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Open-Label Extension Study Of Safety And Tolerability Of Pregabalin In Pediatric Patients With Partial-Onset Seizures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00448916
Recruitment Status : Completed
First Posted : March 19, 2007
Results First Posted : December 2, 2014
Last Update Posted : December 2, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Epilepsies, Partial
Intervention Drug: Pregabalin
Enrollment 54
Recruitment Details This study was a dose extension study of pediatric participants with refractory partial-onset seizures who had completed study A0081074 (NCT00437281). Participants were enrolled in 3 countries at 13 study centers with 13 investigators: Republic of Korea (1 center), Mexico (1 center), and the United States (11 centers).
Pre-assignment Details Each participant was restricted to the dose levels that they had previously tolerated, or that had shown acceptable safety and tolerability in study A0081074 (NCT00437281) for the participant’s age group.
Arm/Group Title Pregabalin: 1-23 Months Pregabalin: 2-6 Years Pregabalin: 7-11 Years Pregabalin: 12-16 Years
Hide Arm/Group Description Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months. Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.. Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months. Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
Period Title: Overall Study
Started 16 15 12 11
Completed 9 9 6 5
Not Completed 7 6 6 6
Reason Not Completed
Adverse Event             2             2             3             2
Lack of Efficacy             1             0             2             1
Withdrawal by Subject             3             3             1             1
Not specified             1             0             0             0
Lost to Follow-up             0             1             0             1
Protocol Violation             0             0             0             1
Arm/Group Title Pregabalin: 1-23 Months Pregabalin: 2-6 Years Pregabalin: 7-11 Years Pregabalin: 12-16 Years Total
Hide Arm/Group Description Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months. Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.. Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months. Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months. Total of all reporting groups
Overall Number of Baseline Participants 16 15 12 11 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 15 participants 12 participants 11 participants 54 participants
1.18  (0.57) 4.14  (1.23) 9.98  (1.30) 14.86  (1.53) 6.74  (5.35)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 15 participants 12 participants 11 participants 54 participants
Female
8
  50.0%
9
  60.0%
5
  41.7%
3
  27.3%
25
  46.3%
Male
8
  50.0%
6
  40.0%
7
  58.3%
8
  72.7%
29
  53.7%
1.Primary Outcome
Title Number of Participants With Adverse Events (AE).
Hide Description An AE is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. A serious adverse event (SAE) is any untoward medical occurrence at any dose that: results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in congenital anomaly/birth defect.
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: All participants who received at least one dose of study medication were included.
Arm/Group Title Pregabalin: 1-23 Months Pregabalin: 2-6 Years Pregabalin: 7-11 Years Pregabalin: 12-16 Years
Hide Arm/Group Description:
Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
Overall Number of Participants Analyzed 16 15 12 11
Measure Type: Number
Unit of Measure: Participants
Participants with AEs 14 13 11 9
Participants with serious AEs 8 3 0 1
Participants with severe AEs 7 4 0 1
2.Secondary Outcome
Title Number of Participants With Change From Previous Physical Examination Results at Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up.
Hide Description Changes from previous examinations in physical examination were reported. Examination of abdomen, breasts, ears, extremities, eyes, genitourinary, head, heart, lungs, lymph nodes, mouth, musculoskeletal, neck, nose, ocular fundi, skin, throat, thyroid and general examinations were done. Evaluation was done based on presence of abnormality which were noted as "abnormal" and no abnormalities in the sites were reported as "normal". Any change from the previous physical examination results were noted.
Time Frame Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: All participants who received at least one dose of study medication were included.
Arm/Group Title Pregabalin: 1-23 Months Pregabalin: 2-6 Years Pregabalin: 7-11 Years Pregabalin: 12-16 Years
Hide Arm/Group Description:
Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
Overall Number of Participants Analyzed 16 15 12 11
Measure Type: Number
Unit of Measure: Participants
Week 1 (N=16,13,11,10) 2 1 0 0
Month 1 (N=14,13,10,10) 1 1 0 0
Month 6 (N=11,10,6,7) 1 1 0 0
Month 12/Eary Termination (N=16,12,12,9) 1 2 1 1
Follow-up (N=6,4,9,6) 0 0 1 0
3.Secondary Outcome
Title Number of Participants With Change From Previous Neurological Examination Results at Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up.
Hide Description Changes from previous examinations in neurological examination were reported. The neurologic exam were performed by a pediatric neurologist or qualified staff member. Coordination, cranial nerves, gait, level of consciousness, lower and upper extremity sensation, muscle strength, muscle tone, nystagmus, reflexes, Romberg test, and speech were examined.
Time Frame Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: All participants who received at least one dose of study medication were included.
Arm/Group Title Pregabalin: 1-23 Months Pregabalin: 2-6 Years Pregabalin: 7-11 Years Pregabalin: 12-16 Years
Hide Arm/Group Description:
Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
Overall Number of Participants Analyzed 16 15 12 11
Measure Type: Number
Unit of Measure: Participants
Week 1 (N=16,13,11,10) 1 0 0 0
Month 1 (N=14,13,10,10) 0 0 0 0
Month 6 (N=11,10,6,7) 0 0 0 0
Month 12/Early Termination (N=16,11,12,9) 0 0 0 0
Follow-up (N=6,4,9,6) 0 0 0 0
4.Secondary Outcome
Title Number of Participants With Significant Change in Supine Diastolic Blood Pressure (BP) at Post-Baseline Visits (Visit 1 to 12 Months).
Hide Description Participants with significant supine diastolic BP values with the criteria ≥ 20% increase from Baseline or ≥ 20% decrease from Baseline or > 1.25 times upper limit of normal (ULN) or < 0.9 times lower limit of normal (LLN) were identified and recorded. The categorical summary of Post-Baseline supine diastolic BP data are presented below.
Time Frame Visit 1 to 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: All participants who received at least one dose of study medication were included.
Arm/Group Title Pregabalin: 1-23 Months Pregabalin: 2-6 Years Pregabalin: 7-11 Years Pregabalin: 12-16 Years
Hide Arm/Group Description:
Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
Overall Number of Participants Analyzed 16 15 12 11
Measure Type: Number
Unit of Measure: Participants
≥ 20% increase from Baseline 12 5 8 3
≥ 20% decrease from Baseline 5 7 3 3
> 1.25 * ULN 1 1 0 0
< 0.9 * LLN 0 0 3 0
5.Secondary Outcome
Title Number of Participants With Significant Change in Supine Systolic BP at Post Baseline Visits (Visit 1 to 12 Months).
Hide Description Participants with significant supine systolic BP values with the criteria ≥ 30% increase from Baseline or ≥ 30% decrease from Baseline or > 1.25 times ULN or < 0.9 times LLN were identified and recorded. The categorical summary of Post-Baseline supine systolic BP data are presented below.
Time Frame Visit 1 to 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: All participants who received at least one dose of study medication were included.
Arm/Group Title Pregabalin: 1-23 Months Pregabalin: 2-6 Years Pregabalin: 7-11 Years Pregabalin: 12-16 Years
Hide Arm/Group Description:
Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
Overall Number of Participants Analyzed 16 15 12 11
Measure Type: Number
Unit of Measure: Participants
≥ 30% increase from Baseline 2 3 1 1
≥ 30% decrease from Baseline 2 1 0 0
> 1.25 * ULN 0 0 0 0
< 0.9 * LLN 0 0 1 0
6.Secondary Outcome
Title Number of Participants With Significant Change in Supine Heart Rate (HR) at Post Baseline Visits (Visit 1 to 12 Months).
Hide Description Participants with significant heart rate values with the criteria > 1.5 times ULN or < 0.9 times LLN were identified and recorded. The categorical summary of Post-Baseline supine HR data are presented below.
Time Frame Visit 1 to 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: All participants who received at least one dose of study medication were included.
Arm/Group Title Pregabalin: 1-23 Months Pregabalin: 2-6 Years Pregabalin: 7-11 Years Pregabalin: 12-16 Years
Hide Arm/Group Description:
Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
Overall Number of Participants Analyzed 16 15 12 11
Measure Type: Number
Unit of Measure: Participants
> 1.5 * ULN 0 0 0 0
< 0.9 * LLN 5 2 1 0
7.Secondary Outcome
Title Derived Body Mass Index Data (BMI) at Month 12/Early Termination.
Hide Description BMI was calculated from height and weight measured at Month 12 visit using the formula: weight(kg)/height(m)2.
Time Frame Month 12/Early Termination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: All participants who received at least one dose of study medication were included. Data was available for 15, 11, 10 and 7 participants in Pregabalin 1-23 months group, 2-6 years group, 7-11 years group and 12-16 years group respectively.
Arm/Group Title Pregabalin: 1-23 Months Pregabalin: 2-6 Years Pregabalin: 7-11 Years Pregabalin: 12-16 Years
Hide Arm/Group Description:
Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
Overall Number of Participants Analyzed 15 11 10 7
Mean (Standard Deviation)
Unit of Measure: Kg/m^2
16.2  (1.73) 18.0  (3.52) 20.6  (6.52) 24.8  (7.72)
8.Secondary Outcome
Title Change From Baseline in Body Weight at Day 9, Week 1, Month 1, Month 2, Month 4, Month 6, Month 9, Month 12/Early Termination and Follow-up.
Hide Description Weight was recorded in kilograms and weight change from Baseline was reported.
Time Frame Baseline, Day 9, Week 1, Month 1, Month 2, Month 4, Month 6, Month 9, Month 12/Early Termination and Follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: All participants who received at least one dose of study medication were included.
Arm/Group Title Pregabalin: 1-23 Months Pregabalin: 2-6 Years Pregabalin: 7-11 Years Pregabalin: 12-16 Years
Hide Arm/Group Description:
Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
Overall Number of Participants Analyzed 16 15 12 11
Mean (Standard Deviation)
Unit of Measure: Kg
Day 9 (N=16,14,12,11) 0.1  (0.16) 0.1  (0.29) -0.1  (0.79) 0.4  (1.07)
Week 1 (N=16,13,11,10) 0.3  (0.29) 0.4  (0.61) 1.5  (1.15) 1.2  (1.43)
Month 1 (N=14,13,10,10) 0.4  (0.45) 0.8  (0.73) 2.1  (1.77) 2.4  (1.52)
Month 2 (N=11,12,8,9) 1.0  (0.73) 1.2  (1.12) 3.8  (3.25) 3.0  (1.81)
Month 4 (N=11,10,7,9) 1.3  (0.86) 1.3  (1.29) 5.2  (4.32) 4.1  (2.28)
Month 6 (N=11,10,6,7) 1.8  (0.98) 1.4  (1.52) 5.9  (4.17) 5.9  (3.32)
Month 9 (N=9,10,6,5) 2.4  (1.18) 2.3  (2.52) 6.3  (4.66) 7.3  (4.32)
Month 12/Early Termination (N=15,12,11,8) 1.8  (1.33) 2.4  (2.71) 6.0  (4.78) 6.6  (4.51)
9.Secondary Outcome
Title Height at Month 12/Early Termination.
Hide Description Height was recorded in centimeters.
Time Frame Month 12/Early Termination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: All participants who received at least one dose of study medication were included.
Arm/Group Title Pregabalin: 1-23 Months Pregabalin: 2-6 Years Pregabalin: 7-11 Years Pregabalin: 12-16 Years
Hide Arm/Group Description:
Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
Overall Number of Participants Analyzed 15 11 10 7
Mean (Standard Deviation)
Unit of Measure: cm
83.3  (8.87) 109.9  (12.76) 145.6  (13.21) 167.3  (8.18)
10.Secondary Outcome
Title Number of Participants With Changes in Electrocardiogram (ECG) Data Post-Baseline Visits (Week 1 to 12 Months).
Hide Description

Based on the criteria for safety values of potential clinical concern, the PR interval (≥200 msec; ≥25% increase from Baseline; ≥50% increase from Baseline), QRS complex (≥200 msec; ≥25% increase from Baseline), QT (≥500 msec), maximum QTcB interval (450-<480; 480-<500; ≥500 msec) and maximum QTcF interval (450-<480; 480-<500; ≥500 msec) values were calculated.

Baseline was defined as Day 1 of the parent study A0081074 (NCT00437281). Categorical data of the Post-Baseline vists are represented below.

Time Frame Week 1 to 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: All participants who received at least one dose of study medication were included.
Arm/Group Title Pregabalin: 1-23 Months Pregabalin: 2-6 Years Pregabalin: 7-11 Years Pregabalin: 12-16 Years
Hide Arm/Group Description:
Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
Overall Number of Participants Analyzed 16 15 12 11
Measure Type: Number
Unit of Measure: Participants
PR interval: ≥ 200 msec 0 0 0 0
PR interval: ≥50% increase from Baseline 0 0 0 0
PR interval: ≥25% increase from Baseline 1 0 1 0
QRS interval: ≥ 200 msec 0 0 0 0
QRS interval: ≥25% increase from Baseline 0 0 0 0
QT interval: ≥ 500 msec 0 0 0 0
QTcB interval: 450-<480 msec 1 1 1 2
QTcB interval: 480-<500 msec 0 0 0 0
QTcB interval: ≥ 500 msec 0 0 0 0
QTcF interval: 450-<480 msec 0 0 0 0
QTcF interval: 480-<500 msec 0 0 0 0
QTcF interval: ≥ 500 msec 0 0 0 0
11.Secondary Outcome
Title Number of Participants With Hematotolgical Abnormalities.
Hide Description Based on criteria for safety values of potential clinical concern, the participants with abnormal values were noted. Some of the values are: platelets (10*3/mm*3): <0.5 LLN or >1.75 ULN; white blood cell (WBC) count (X10E9/L): <0.6 LLN or >1.5 ULN; lymphocytes-Abs (10*3/mm*3): <0.8 LLN or >1.2 ULN; total neutrophils-Abs (10*3/mm*3): <0.8 LLN or >1.2 ULN; and eosinophils-Abs: >1.2 ULN.
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: All participants who received at least one dose of study medication were included.
Arm/Group Title Pregabalin: 1-23 Months Pregabalin: 2-6 Years Pregabalin: 7-11 Years Pregabalin: 12-16 Years
Hide Arm/Group Description:
Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
Overall Number of Participants Analyzed 16 15 12 11
Measure Type: Number
Unit of Measure: Participants
Platelets: <0.5xLLN (N=16,15,12,11) 1 1 0 0
Platelets: >1.75xULN (N=16,15,12,11) 1 0 0 0
WBC count: <0.6xLLN (N=15,15,12,11) 1 2 0 0
WBC count: >1.5xULN (N=15,15,12,11) 0 0 0 0
Lymphocytes-Abs: <0.8xLLN (N=15,15,12,11) 0 0 0 0
Lymphocytes-Abs: >1.2xULN (N=15,15,12,11) 1 0 0 2
Total neutrophils-Abs: <0.8xLLN (N=15,15,12,11) 3 4 3 3
Total neutrophils-Abs: >1.2xULN (N=15,15,12,11) 1 1 0 0
Eosinophils-Abs: >1.2xULN (N=15,15,12,11) 3 1 1 0
Hemoglobin: <0.8xLLN(N=15,15,12,11) 0 0 0 0
Hematocrit: <0.8xLLN (N=15,15,12,11) 0 0 0 0
Red blood cell count: <0.8xLLN (N=15,15,12,11) 0 0 0 0
Basophils: >1.2xULN (N=15,15,12,11) 0 0 0 0
Monocytes: >1.2xULN (N=15,15,12,11) 0 0 0 0
12.Secondary Outcome
Title Number of Participants With Abnormalities in Urinalysis (Dipstick/Microscopy).
Hide Description Based on criteria for safety values of potential clinical concern, the participants with abnormal values were noted. Participants with Urine Protein (mg/dL) abnormalities (≥1) were noted based on urinalysis (dipstick). No participants with abnormalities in urinalysis (microscopy) were noted.
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: All participants who received at least one dose of study medication were included.
Arm/Group Title Pregabalin: 1-23 Months Pregabalin: 2-6 Years Pregabalin: 7-11 Years Pregabalin: 12-16 Years
Hide Arm/Group Description:
Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
Overall Number of Participants Analyzed 11 15 11 11
Measure Type: Number
Unit of Measure: Participants
1 1 0 1
13.Secondary Outcome
Title Number of Participants With Abnormalities in Endocrine Panel (Hormones).
Hide Description Based on criteria for safety values of potential clinical concern, the participants with abnormal values were noted. Some of the criteria are: Free thyroxine (T4 free) (ng/dL): <0.8 LLN or >1.2 ULN and Thyroid-stimulating hormone (TSH) (mu/L): <0.8 LLN or >1.2 ULN.
Time Frame 12 Months
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Hide Analysis Population Description
Safety analysis set: All participants who received at least one dose of study medication were included.
Arm/Group Title Pregabalin: 1-23 Months Pregabalin: 2-6 Years Pregabalin: 7-11 Years Pregabalin: 12-16 Years
Hide Arm/Group Description:
Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
Overall Number of Participants Analyzed 16 15 12 11
Measure Type: Number
Unit of Measure: Participants
T4 (free): <0.8xLLN (N=13,13,11,10) 0 1 0 0
T4 (free): >1.2xULN (N=13,13,11,10) 0 0 0 0
TSH: <0.8xLLN (N=14,12,11,10) 1 0 0 0
TSH: >1.2xULN (N=14,12,11,10) 0 0 0 0
14.Secondary Outcome
Title Number of Participants With Abnormalities in Creatine Kinase.
Hide Description Based on criteria for safety values of potential clinical concern, the participants with abnormal values in creatine kinase (>2.0 times upper limit of the reference range) (u/L) were noted.
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: All participants who received at least one dose of study medication were included.
Arm/Group Title Pregabalin: 1-23 Months Pregabalin: 2-6 Years Pregabalin: 7-11 Years Pregabalin: 12-16 Years
Hide Arm/Group Description:
Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
Overall Number of Participants Analyzed 15 15 12 11
Measure Type: Number
Unit of Measure: Participants
0 1 1 4
15.Secondary Outcome
Title Seizure Frequency.
Hide Description Twenty-eight-day seizure frequencies were to be calculated from the seizure diaries and were to be reviewed. However, due to the nature of the data collection and due to unability to clearly differentiate no seizures versus seizures, accurate computation of this data was not performed. Hence, the seizure data was reported as AE.
Time Frame 28 Days
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Hide Analysis Population Description
Safety analysis set: All participants who received at least one dose of study medication were included.
Arm/Group Title Pregabalin: 1-23 Months Pregabalin: 2-6 Years Pregabalin: 7-11 Years Pregabalin: 12-16 Years
Hide Arm/Group Description:
Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
Overall Number of Participants Analyzed 16 15 12 11
Measure Type: Number
Unit of Measure: Participants
NA [1]  NA [1]  NA [1]  NA [1] 
[1]
Due to the nature of the data collection and due to unability to clearly differentiate no seizures versus seizures, accurate computation of this data was not performed
16.Secondary Outcome
Title Number of Participants With Abnormalities in Chemistry (Including Liver Function, Renal Function, Lipids, Electrolytes, Glucose, Insulin Like Growth Factor (IGF) and IGF Binding Protein).
Hide Description Based on criteria for safety values of potential clinical concern, the participants with abnormal values in liver function tests, renal function tests, lipid profile, electrolytes, glucose, Insulin like growth factor (IGF) and IGF binding protein were noted and reported in this section.
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: All participants who received at least one dose of study medication were included.
Arm/Group Title Pregabalin: 1-23 Months Pregabalin: 2-6 Years Pregabalin: 7-11 Years Pregabalin: 12-16 Years
Hide Arm/Group Description:
Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
Overall Number of Participants Analyzed 15 15 12 11
Measure Type: Number
Unit of Measure: Participants
Alanine Aminotransferase: >3.0xULN (N=15,15,12,11) 0 1 1 0
Blood Urea Nitrogen: >1.3xULN 2 5 1 0
Albumin: <0.8xLLN (N=15,15,12,11) 0 0 0 0
Albumin: >1.2xULN (N=15,15,12,11) 2 0 0 0
Potassium: <0.9xLLN (N=15,15,12,11) 0 0 0 0
Potassium: >1.1xULN (N=15,15,12,11) 1 0 1 0
Magnesium: <0.9xLLN (N=15,15,12,11) 0 0 0 0
Magnesium: >1.1xULN (N=15,15,12,11) 1 2 0 1
Phosphate: <0.8xLLN (N=15,15,12,11) 0 0 0 0
Phosphate: >1.2xULN (N=15,15,12,11) 0 1 1 0
Bicarbonate (venous): <0.9xLLN (N=15,15,12,11) 9 11 7 3
Bicarbonate (venous): >1.1xULN (N=15,15,12,11) 0 0 0 0
Glucose: <0.6xLLN (N=15,15,12,11) 1 1 0 0
Glucose: >1.5xULN (N=15,15,12,11) 0 0 0 0
Insulin-like GrowthFactor:<0.9xLLN(N=12,13,11,10) 0 0 1 0
Insulin-like GrowthFactor:>1.1xULN(N=12,13,11,10) 5 8 4 6
IGF Binding Protein: <0.9xLLN (N=12,13,11,10) 0 0 0 0
IGF Binding Protein: >1.1xULN (N=12,13,11,10) 4 2 5 0
Lipid profile cholesterol/triglycerides(N=1,4,0,1) 0 0 0 0
Time Frame From Visit 1 to Visit 9 (Follow-up visit)
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Pregabalin: 1-23 Months Pregabalin: 2-6 Years Pregabalin: 7-11 Years Pregabalin: 12-16 Years Overall
Hide Arm/Group Description Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months. Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.. Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months. Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months. This arm summarizes the AE data from all the treatment groups.
All-Cause Mortality
Pregabalin: 1-23 Months Pregabalin: 2-6 Years Pregabalin: 7-11 Years Pregabalin: 12-16 Years Overall
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pregabalin: 1-23 Months Pregabalin: 2-6 Years Pregabalin: 7-11 Years Pregabalin: 12-16 Years Overall
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/16 (50.00%)   3/15 (20.00%)   0/12 (0.00%)   1/11 (9.09%)   12/54 (22.22%) 
Blood and lymphatic system disorders           
Thrombocytopenia * 1  1/16 (6.25%)  0/15 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Gastrointestinal disorders           
Gastritis * 1  0/16 (0.00%)  1/15 (6.67%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Gastrooesophageal reflux disease * 1  1/16 (6.25%)  0/15 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Ileus * 1  1/16 (6.25%)  0/15 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Salivary hypersecretion * 1  1/16 (6.25%)  0/15 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Infections and infestations           
Croup infectious * 1  1/16 (6.25%)  0/15 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Otitis media acute * 1  1/16 (6.25%)  0/15 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Pneumonia * 1  1/16 (6.25%)  1/15 (6.67%)  0/12 (0.00%)  0/11 (0.00%)  2/54 (3.70%) 
Respiratory syncytial virus bronchiolitis * 1  1/16 (6.25%)  0/15 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Upper respiratory tract infection * 1  0/16 (0.00%)  1/15 (6.67%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Nervous system disorders           
Convulsion * 1  3/16 (18.75%)  0/15 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  3/54 (5.56%) 
Status epilepticus * 1  1/16 (6.25%)  1/15 (6.67%)  0/12 (0.00%)  0/11 (0.00%)  2/54 (3.70%) 
Unresponsive to stimuli * 1  0/16 (0.00%)  0/15 (0.00%)  0/12 (0.00%)  1/11 (9.09%)  1/54 (1.85%) 
Respiratory, thoracic and mediastinal disorders           
Apnoea * 1  1/16 (6.25%)  0/15 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Bronchial hyperreactivity * 1  1/16 (6.25%)  0/15 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Respiratory distress * 1  0/16 (0.00%)  1/15 (6.67%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Respiratory failure * 1  1/16 (6.25%)  0/15 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pregabalin: 1-23 Months Pregabalin: 2-6 Years Pregabalin: 7-11 Years Pregabalin: 12-16 Years Overall
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   14/16 (87.50%)   13/15 (86.67%)   11/12 (91.67%)   9/11 (81.82%)   47/54 (87.04%) 
Blood and lymphatic system disorders           
Cyclic neutropenia * 1  1/16 (6.25%)  0/15 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Leukocytosis * 1  0/16 (0.00%)  1/15 (6.67%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Neutropenia * 1  1/16 (6.25%)  0/15 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Normochromic normocytic anaemia * 1  1/16 (6.25%)  0/15 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Thrombocytosis * 1  1/16 (6.25%)  0/15 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Cardiac disorders           
Bundle branch block left * 1  1/16 (6.25%)  0/15 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Congenital, familial and genetic disorders           
Cryptorchism * 1  1/16 (6.25%)  0/15 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Ear and labyrinth disorders           
Ear pain * 1  0/16 (0.00%)  1/15 (6.67%)  0/12 (0.00%)  1/11 (9.09%)  2/54 (3.70%) 
Eye disorders           
Astigmatism * 1  1/16 (6.25%)  0/15 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Conjunctivitis * 1  1/16 (6.25%)  1/15 (6.67%)  0/12 (0.00%)  0/11 (0.00%)  2/54 (3.70%) 
Excessive eye blinking * 1  0/16 (0.00%)  0/15 (0.00%)  1/12 (8.33%)  0/11 (0.00%)  1/54 (1.85%) 
Hypermetropia * 1  1/16 (6.25%)  0/15 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Gastrointestinal disorders           
Abdominal distension * 1  2/16 (12.50%)  0/15 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  2/54 (3.70%) 
Abdominal pain * 1  3/16 (18.75%)  0/15 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  3/54 (5.56%) 
Abdominal tenderness * 1  1/16 (6.25%)  0/15 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Constipation * 1  5/16 (31.25%)  1/15 (6.67%)  1/12 (8.33%)  0/11 (0.00%)  7/54 (12.96%) 
Diarrhoea * 1  3/16 (18.75%)  3/15 (20.00%)  0/12 (0.00%)  0/11 (0.00%)  6/54 (11.11%) 
Faeces pale * 1  1/16 (6.25%)  0/15 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Gastrooesophageal reflux disease * 1  3/16 (18.75%)  0/15 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  3/54 (5.56%) 
Retching * 1  0/16 (0.00%)  1/15 (6.67%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Salivary hypersecretion * 1  1/16 (6.25%)  0/15 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Tooth impacted * 1  0/16 (0.00%)  0/15 (0.00%)  0/12 (0.00%)  1/11 (9.09%)  1/54 (1.85%) 
Vomiting * 1  2/16 (12.50%)  1/15 (6.67%)  0/12 (0.00%)  1/11 (9.09%)  4/54 (7.41%) 
General disorders           
Chest pain * 1  0/16 (0.00%)  0/15 (0.00%)  0/12 (0.00%)  1/11 (9.09%)  1/54 (1.85%) 
Crying * 1  0/16 (0.00%)  0/15 (0.00%)  1/12 (8.33%)  0/11 (0.00%)  1/54 (1.85%) 
Fatigue * 1  0/16 (0.00%)  1/15 (6.67%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Irritability * 1  3/16 (18.75%)  0/15 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  3/54 (5.56%) 
Pyrexia * 1  9/16 (56.25%)  3/15 (20.00%)  0/12 (0.00%)  3/11 (27.27%)  15/54 (27.78%) 
Thirst * 1  0/16 (0.00%)  0/15 (0.00%)  1/12 (8.33%)  0/11 (0.00%)  1/54 (1.85%) 
Infections and infestations           
Bacterial sepsis * 1  1/16 (6.25%)  0/15 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Bronchitis * 1  0/16 (0.00%)  0/15 (0.00%)  0/12 (0.00%)  1/11 (9.09%)  1/54 (1.85%) 
Cystitis * 1  0/16 (0.00%)  0/15 (0.00%)  0/12 (0.00%)  1/11 (9.09%)  1/54 (1.85%) 
Device related infection * 1  1/16 (6.25%)  0/15 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Ear infection * 1  0/16 (0.00%)  4/15 (26.67%)  1/12 (8.33%)  0/11 (0.00%)  5/54 (9.26%) 
Eye infection * 1  1/16 (6.25%)  0/15 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Gastroenteritis * 1  1/16 (6.25%)  1/15 (6.67%)  0/12 (0.00%)  0/11 (0.00%)  2/54 (3.70%) 
Hordeolum * 1  1/16 (6.25%)  0/15 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Nasopharyngitis * 1  3/16 (18.75%)  0/15 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  3/54 (5.56%) 
Otitis media * 1  4/16 (25.00%)  4/15 (26.67%)  0/12 (0.00%)  0/11 (0.00%)  8/54 (14.81%) 
Otitis media acute * 1  2/16 (12.50%)  1/15 (6.67%)  0/12 (0.00%)  0/11 (0.00%)  3/54 (5.56%) 
Pharyngitis streptococcal * 1  0/16 (0.00%)  2/15 (13.33%)  1/12 (8.33%)  0/11 (0.00%)  3/54 (5.56%) 
Pharyngotonsillitis * 1  1/16 (6.25%)  0/15 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Pneumonia * 1  1/16 (6.25%)  0/15 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Rhinitis * 1  2/16 (12.50%)  1/15 (6.67%)  0/12 (0.00%)  0/11 (0.00%)  3/54 (5.56%) 
Sinusitis * 1  0/16 (0.00%)  0/15 (0.00%)  0/12 (0.00%)  1/11 (9.09%)  1/54 (1.85%) 
Staphylococcal infection * 1  0/16 (0.00%)  1/15 (6.67%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Tinea infection * 1  0/16 (0.00%)  0/15 (0.00%)  0/12 (0.00%)  1/11 (9.09%)  1/54 (1.85%) 
Upper respiratory tract infection * 1  3/16 (18.75%)  5/15 (33.33%)  2/12 (16.67%)  0/11 (0.00%)  10/54 (18.52%) 
Urinary tract infection * 1  0/16 (0.00%)  0/15 (0.00%)  1/12 (8.33%)  0/11 (0.00%)  1/54 (1.85%) 
Viral upper respiratory tract infection * 1  1/16 (6.25%)  0/15 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Injury, poisoning and procedural complications           
Anal injury * 1  1/16 (6.25%)  0/15 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Arthropod bite * 1  0/16 (0.00%)  0/15 (0.00%)  1/12 (8.33%)  0/11 (0.00%)  1/54 (1.85%) 
Arthropod sting * 1  0/16 (0.00%)  0/15 (0.00%)  1/12 (8.33%)  0/11 (0.00%)  1/54 (1.85%) 
Excoriation * 1  0/16 (0.00%)  0/15 (0.00%)  0/12 (0.00%)  2/11 (18.18%)  2/54 (3.70%) 
Fall * 1  1/16 (6.25%)  0/15 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Foot fracture * 1  0/16 (0.00%)  0/15 (0.00%)  0/12 (0.00%)  1/11 (9.09%)  1/54 (1.85%) 
Laceration * 1  0/16 (0.00%)  0/15 (0.00%)  0/12 (0.00%)  1/11 (9.09%)  1/54 (1.85%) 
Investigations           
Alanine aminotransferase increased * 1  0/16 (0.00%)  0/15 (0.00%)  1/12 (8.33%)  0/11 (0.00%)  1/54 (1.85%) 
Anticonvulsant drug level increased * 1  1/16 (6.25%)  0/15 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Blood thyroid stimulating hormone decreased * 1  1/16 (6.25%)  0/15 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Neutrophil count decreased * 1  0/16 (0.00%)  1/15 (6.67%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Weight increased * 1  0/16 (0.00%)  1/15 (6.67%)  1/12 (8.33%)  0/11 (0.00%)  2/54 (3.70%) 
Metabolism and nutrition disorders           
Dehydration * 1  2/16 (12.50%)  1/15 (6.67%)  0/12 (0.00%)  0/11 (0.00%)  3/54 (5.56%) 
Hyperkalaemia * 1  1/16 (6.25%)  0/15 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Increased appetite * 1  0/16 (0.00%)  1/15 (6.67%)  1/12 (8.33%)  0/11 (0.00%)  2/54 (3.70%) 
Metabolic acidosis * 1  1/16 (6.25%)  0/15 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Polydipsia * 1  0/16 (0.00%)  1/15 (6.67%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Musculoskeletal and connective tissue disorders           
Muscle twitching * 1  0/16 (0.00%)  0/15 (0.00%)  1/12 (8.33%)  0/11 (0.00%)  1/54 (1.85%) 
Musculoskeletal pain * 1  0/16 (0.00%)  1/15 (6.67%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Nervous system disorders           
Cognitive disorder * 1  0/16 (0.00%)  0/15 (0.00%)  1/12 (8.33%)  0/11 (0.00%)  1/54 (1.85%) 
Convulsion * 1  2/16 (12.50%)  1/15 (6.67%)  3/12 (25.00%)  1/11 (9.09%)  7/54 (12.96%) 
Dizziness * 1  0/16 (0.00%)  0/15 (0.00%)  1/12 (8.33%)  1/11 (9.09%)  2/54 (3.70%) 
Headache * 1  0/16 (0.00%)  0/15 (0.00%)  1/12 (8.33%)  0/11 (0.00%)  1/54 (1.85%) 
Lethargy * 1  0/16 (0.00%)  2/15 (13.33%)  0/12 (0.00%)  1/11 (9.09%)  3/54 (5.56%) 
Partial seizures * 1  1/16 (6.25%)  0/15 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Somnolence * 1  2/16 (12.50%)  0/15 (0.00%)  1/12 (8.33%)  1/11 (9.09%)  4/54 (7.41%) 
Status epilepticus * 1  0/16 (0.00%)  1/15 (6.67%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Psychiatric disorders           
Aggression * 1  0/16 (0.00%)  0/15 (0.00%)  1/12 (8.33%)  0/11 (0.00%)  1/54 (1.85%) 
Anger * 1  0/16 (0.00%)  0/15 (0.00%)  0/12 (0.00%)  1/11 (9.09%)  1/54 (1.85%) 
Attention deficit/hyperactivity disorder * 1  0/16 (0.00%)  1/15 (6.67%)  1/12 (8.33%)  0/11 (0.00%)  2/54 (3.70%) 
Depression * 1  0/16 (0.00%)  0/15 (0.00%)  0/12 (0.00%)  1/11 (9.09%)  1/54 (1.85%) 
Dissociation * 1  0/16 (0.00%)  0/15 (0.00%)  1/12 (8.33%)  0/11 (0.00%)  1/54 (1.85%) 
Dysphemia * 1  1/16 (6.25%)  0/15 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Dyssomnia * 1  1/16 (6.25%)  0/15 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Hallucination, visual * 1  0/16 (0.00%)  0/15 (0.00%)  1/12 (8.33%)  0/11 (0.00%)  1/54 (1.85%) 
Insomnia * 1  1/16 (6.25%)  0/15 (0.00%)  1/12 (8.33%)  0/11 (0.00%)  2/54 (3.70%) 
Personality change * 1  0/16 (0.00%)  1/15 (6.67%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Restlessness * 1  1/16 (6.25%)  0/15 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Renal and urinary disorders           
Proteinuria * 1  2/16 (12.50%)  0/15 (0.00%)  1/12 (8.33%)  0/11 (0.00%)  3/54 (5.56%) 
Urine odour abnormal * 1  0/16 (0.00%)  1/15 (6.67%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Respiratory, thoracic and mediastinal disorders           
Bronchospasm * 1  1/16 (6.25%)  0/15 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Cough * 1  4/16 (25.00%)  2/15 (13.33%)  0/12 (0.00%)  0/11 (0.00%)  6/54 (11.11%) 
Epistaxis * 1  0/16 (0.00%)  2/15 (13.33%)  1/12 (8.33%)  1/11 (9.09%)  4/54 (7.41%) 
Hypoxia * 1  1/16 (6.25%)  0/15 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Nasal congestion * 1  2/16 (12.50%)  3/15 (20.00%)  1/12 (8.33%)  0/11 (0.00%)  6/54 (11.11%) 
Productive cough * 1  2/16 (12.50%)  1/15 (6.67%)  0/12 (0.00%)  0/11 (0.00%)  3/54 (5.56%) 
Respiratory distress * 1  1/16 (6.25%)  0/15 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Rhinorrhoea * 1  1/16 (6.25%)  2/15 (13.33%)  0/12 (0.00%)  0/11 (0.00%)  3/54 (5.56%) 
Rhonchi * 1  0/16 (0.00%)  1/15 (6.67%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Snoring * 1  1/16 (6.25%)  0/15 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Upper-airway cough syndrome * 1  0/16 (0.00%)  0/15 (0.00%)  1/12 (8.33%)  0/11 (0.00%)  1/54 (1.85%) 
Wheezing * 1  0/16 (0.00%)  1/15 (6.67%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Skin and subcutaneous tissue disorders           
Dermatitis contact * 1  1/16 (6.25%)  0/15 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Dermatitis diaper * 1  3/16 (18.75%)  1/15 (6.67%)  0/12 (0.00%)  0/11 (0.00%)  4/54 (7.41%) 
Pruritus * 1  0/16 (0.00%)  0/15 (0.00%)  1/12 (8.33%)  0/11 (0.00%)  1/54 (1.85%) 
Rash * 1  0/16 (0.00%)  1/15 (6.67%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
Surgical and medical procedures           
Adenoidectomy * 1  1/16 (6.25%)  0/15 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/54 (1.85%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00448916     History of Changes
Other Study ID Numbers: A0081075
2010-020731-39 ( EudraCT Number )
First Submitted: March 15, 2007
First Posted: March 19, 2007
Results First Submitted: October 6, 2014
Results First Posted: December 2, 2014
Last Update Posted: December 2, 2014