Safety, Tolerability, and Pharmacokinetic Study of Pregabalin in Pediatric Patients With Partial Onset Seizures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00437281
First received: February 16, 2007
Last updated: January 29, 2014
Last verified: January 2014
Results First Received: September 16, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Epilepsies, Partial
Interventions: Drug: Placebo
Drug: Pregabalin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants who completed this study and who tolerated study medication were eligible to enroll in study A0081075 (NCT00448916), a 12-month open-label extension study of pregabalin.

Reporting Groups
  Description
Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months) Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 milligram per kilogram per day (mg/kg/day) in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months) Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months) Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months) Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
Placebo (Age Cohort: 1 to 23 Months) Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years) Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years) Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years) Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years) Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
Placebo (Age Cohort: 2 to 6 Years) Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years) Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years) Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years) Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years) Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
Placebo (Age Cohort: 7 to 11 Years) Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years) Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years) Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years) Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years) Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
Placebo (Age Cohort: 12 to 16 Years) Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.

Participant Flow:   Overall Study
    Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)     Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)     Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)     Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)     Placebo (Age Cohort: 1 to 23 Months)     Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)     Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)     Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)     Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)     Placebo (Age Cohort: 2 to 6 Years)     Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)     Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)     Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)     Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)     Placebo (Age Cohort: 7 to 11 Years)     Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)     Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)     Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)     Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)     Placebo (Age Cohort: 12 to 16 Years)  
STARTED     3     3     3     3     4     4     3     3     3     5     3     3     2     3     5     3     3     4     2     3  
COMPLETED     3     3     3     2     4     3     3     3     3     4     3     3     2     2     4     3     3     4     1     2  
NOT COMPLETED     0     0     0     1     0     1     0     0     0     1     0     0     0     1     1     0     0     0     1     1  
Adverse Event                 0                 0                 0                 1                 0                 1                 0                 0                 0                 1                 0                 0                 0                 1                 1                 0                 0                 0                 1                 0  
Lost to Follow-up                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months) Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 milligram per kilogram per day (mg/kg/day) in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months) Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months) Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months) Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
Placebo (Age Cohort: 1 to 23 Months) Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years) Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years) Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years) Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years) Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
Placebo (Age Cohort: 2 to 6 Years) Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years) Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years) Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years) Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years) Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
Placebo (Age Cohort: 7 to 11 Years) Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years) Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years) Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years) Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years) Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
Placebo (Age Cohort: 12 to 16 Years) Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
Total Total of all reporting groups

Baseline Measures
    Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)     Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)     Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)     Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)     Placebo (Age Cohort: 1 to 23 Months)     Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)     Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)     Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)     Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)     Placebo (Age Cohort: 2 to 6 Years)     Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)     Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)     Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)     Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)     Placebo (Age Cohort: 7 to 11 Years)     Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)     Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)     Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)     Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)     Placebo (Age Cohort: 12 to 16 Years)     Total  
Number of Participants  
[units: participants]
  3     3     3     3     4     4     3     3     3     5     3     3     2     3     5     3     3     4     2     3     65  
Age  
[units: years]
Mean ± Standard Deviation
  1.2  ± 0.7     1.4  ± 0.5     0.7  ± 0.5     0.6  ± 0.1     1.6  ± 0.3     4.0  ± 0.8     2.9  ± 0.1     4.0  ± 1.7     3.9  ± 1.8     3.7  ± 1.0     9.3  ± 1.2     9.7  ± 2.3     10.0  ± 0.0     9.0  ± 1.0     9.2  ± 1.5     15.7  ± 0.6     13.7  ± 2.1     14.0  ± 1.8     15.5  ± 0.7     13.0  ± 1.7     6.9  ± 5.2  
Gender  
[units: participants]
                                         
Female     1     2     1     2     2     4     2     1     1     3     2     1     0     0     4     2     1     0     0     3     32  
Male     2     1     2     1     2     0     1     2     2     2     1     2     2     3     1     1     2     4     2     0     33  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Treatment-Emergent Adverse Events (AEs) by Severity: Double-blind Treatment   [ Time Frame: Baseline to Day 7 ]

2.  Primary:   Number of Treatment-Emergent Adverse Events (AEs) by Severity: Open-label Treatment   [ Time Frame: Day 8 up to 28 days after open-label dose of study medication ]

3.  Secondary:   Number of Participants With Clinically Significant Change in Physical and Neurological Findings   [ Time Frame: Baseline up to 7 days post-last dose of study medication ]

4.  Secondary:   28-Day Seizure Frequency Rate   [ Time Frame: Baseline up to 7 days post-last dose of study medication ]

5.  Secondary:   Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau): Multiple-Dose Analysis   [ Time Frame: Pre-dose, 0.5, 1, 2, 4, 8, 12 hours post-dose on Day 8 ]

6.  Secondary:   Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: Single-Dose Analysis   [ Time Frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8 ]

7.  Secondary:   Maximum Observed Plasma Concentration (Cmax): Multiple-Dose Analysis   [ Time Frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8 ]

8.  Secondary:   Maximum Observed Plasma Concentration (Cmax): Single-Dose Analysis   [ Time Frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8 ]

9.  Secondary:   Time to Reach Maximum Observed Plasma Concentration (Tmax): Multiple-Dose Analysis   [ Time Frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8 ]

10.  Secondary:   Time to Reach Maximum Observed Plasma Concentration (Tmax): Single-Dose Analysis   [ Time Frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8 ]

11.  Secondary:   Plasma Decay Half-Life (t1/2): Multiple-Dose Analysis   [ Time Frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8 ]

12.  Secondary:   Plasma Decay Half-Life (t1/2): Single-Dose Analysis   [ Time Frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8 ]

13.  Secondary:   Apparent Oral Clearance (CL/F): Multiple-Dose Analysis   [ Time Frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8 ]

14.  Secondary:   Apparent Oral Clearance (CL/F): Single-Dose Analysis   [ Time Frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8 ]

15.  Secondary:   Renal Clearance (CLr): Multiple-Dose Analysis   [ Time Frame: 0 to 12 hours post-dose, 12 to 24 hours post-dose on Day 8 ]

16.  Secondary:   Renal Clearance (CLr): Single-Dose Analysis   [ Time Frame: 0 to 12 hours post-dose, 12 to 24 hours post-dose on Day 8 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Results are reported for AUCtau for multiple-dose PK analysis and AUC (0-∞) for single-dose PK analysis, instead of AUC (0-24), as per change in planned analysis.  


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00437281     History of Changes
Other Study ID Numbers: A0081074
Study First Received: February 16, 2007
Results First Received: September 16, 2013
Last Updated: January 29, 2014
Health Authority: United States: Food and Drug Administration