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An Open-Label Study Of Celecoxib In Patients With Posttraumatic Pain

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ClinicalTrials.gov Identifier: NCT00976716
Recruitment Status : Completed
First Posted : September 14, 2009
Results First Posted : May 19, 2011
Last Update Posted : May 19, 2011
Sponsor:
Information provided by:
Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pain
Intervention Drug: Celecoxib
Enrollment 80
Recruitment Details Subjects were screened at 12 centers in Japan.
Pre-assignment Details  
Arm/Group Title Celecoxib
Hide Arm/Group Description Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID (twice daily) for up to 7 days from Day 2.
Period Title: Overall Study
Started 80
Completed 79
Not Completed 1
Reason Not Completed
Adverse Event             1
Arm/Group Title Celecoxib
Hide Arm/Group Description Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
Overall Number of Baseline Participants 80
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 80 participants
37.1  (14.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants
Female
39
  48.8%
Male
41
  51.2%
1.Primary Outcome
Title Patient Impressions at Final Visit (the Number of Participants Who Have Rated “Excellent” and “Good”)
Hide Description

The patient impression of the study medication was entered in the patient diary based on the following categories: “excellent,” “good,” “fair” and “poor.”

Efficacy was based on the patient impression of the study medication (“excellent” and “good”) from the first study medication until Final Visit.

Time Frame 8 days
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the last observation carried forward (LOCF) was used.
Arm/Group Title Celecoxib
Hide Arm/Group Description:
Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
Overall Number of Participants Analyzed 80
Measure Type: Number
Unit of Measure: Participants
70
2.Secondary Outcome
Title Patient Impressions Within 8 Days Post-first Dose (the Number of Subjects Who Have Rated “Excellent” and “Good”)
Hide Description

The patient impression of the study medication was entered in the patient diary based on the following categories: “excellent,” “good,” “fair” and “poor.”

Efficacy was based on the patient impression of the study medication ("excellent" and "good") from the first study medication until each time point.

Time Frame 6 hours post first dose and before sleep on Day 1, before sleep on Day 2, Day 4 (Visit 2) and Day 8 (Visit 3)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints.
Arm/Group Title Celecoxib
Hide Arm/Group Description:
Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
Overall Number of Participants Analyzed 80
Measure Type: Number
Unit of Measure: Participants
Day 1, 6 hours post first dose (n=80) 44
Day 1, before sleep (n=80) 48
Day 2, before sleep (n=80) 55
Visit 2 (Day 4), (n=80) 60
Visit 3 (Day 8), (n=68) 60
3.Secondary Outcome
Title Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose
Hide Description The PI of pain at rest (spontaneous pain) was recorded on the 100 mm VAS in the patient diary, where 0 mm=no pain, 100 mm=worst possible pain.
Time Frame Baseline, 2, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used.
Arm/Group Title Celecoxib
Hide Arm/Group Description:
Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
Overall Number of Participants Analyzed 80
Mean (Standard Deviation)
Unit of Measure: mm
Baseline (n=80) 59.9  (11.4)
Day 1, 2 hours post first dose (n=80) 47.3  (19.5)
Day 1, 4 hours post first dose (n=80) 42.5  (20.5)
Day 1, 6 hours post first dose (n=80) 40.3  (20.9)
Day 1, before sleep (n=80) 38.1  (20.0)
Day 2, on awakening (n=80) 34.8  (21.5)
Day 2, before sleep (n=80) 29.0  (22.0)
Day 3, on awakening (n=80) 24.8  (20.0)
Day 3, before sleep (n=78) 21.8  (19.1)
Day 4, on awakening (n=78) 18.4  (19.6)
Day 4, before sleep (n=73) 17.8  (18.9)
Day 5, on awakening (n=73) 15.3  (18.0)
Day 5, before sleep (n=68) 15.0  (18.7)
Day 6, on awakening (n=68) 12.4  (17.2)
Day 6, before sleep (n=68) 11.6  (17.3)
Day 7, on awakening (n=68) 11.3  (18.1)
Day 7, before sleep (n=55) 9.7  (16.2)
Day 8, on awakening (n=55) 8.6  (13.3)
Visit 3 (Day 8) (n=73) 7.2  (13.0)
Final Visit (LOCF, n=80) 7.3  (13.4)
4.Secondary Outcome
Title PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose
Hide Description The PI of pain on active movement was recorded on the 100 mm VAS in the patient diary, where 0 mm=no pain, 100 mm=worst possible pain.
Time Frame Baseline, 2, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used.
Arm/Group Title Celecoxib
Hide Arm/Group Description:
Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2
Overall Number of Participants Analyzed 79
Mean (Standard Deviation)
Unit of Measure: mm
Baseline (n=79) 75.5  (12.7)
Day 1, 2 hours post first dose (n=77) 61.4  (20.2)
Day 1, 4 hours post first dose (n=77) 55.3  (21.0)
Day 1, 6 hours post first dose (n=77) 51.5  (20.6)
Day 1, before sleep (n=77) 49.3  (21.0)
Day 2, on awakening (n=77) 45.5  (21.4)
Day 2, before sleep (n=77) 39.7  (22.6)
Day 3, on awakening (n=77) 35.5  (22.3)
Day 3, before sleep (n=75) 32.4  (21.8)
Day 4, on awakening (n=75) 27.2  (22.9)
Day 4, before sleep (n=70) 26.4  (21.0)
Day 5, on awakening (n=70) 23.5  (21.4)
Day 5, before sleep (n=66) 23.2  (22.0)
Day 6, on awakening (n=66) 19.2  (20.4)
Day 6, before sleep (n=66) 18.2  (20.1)
Day 7, on awakening (n=66) 17.1  (21.7)
Day 7, before sleep (n=55) 15.5  (20.7)
Day 8, on awakening (n=55) 14.3  (20.0)
Visit 3 (Day8) (n=71) 12.1  (18.7)
Final Visit (LOCF, n=78) 11.8  (18.7)
5.Secondary Outcome
Title Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose
Hide Description The PID score was obtained by subtracting the PI (by VAS: 0 mm=no pain, 100 mm=worst possible pain) at each time point from the Baseline PI score. Increase in PID scores indicated a lessening of subjects' pain compared to baseline scores; higher scores indicated a greater reduction in pain.
Time Frame Two, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used.
Arm/Group Title Celecoxib
Hide Arm/Group Description:
Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
Overall Number of Participants Analyzed 80
Mean (Standard Deviation)
Unit of Measure: mm
Day 1, 2 hours post first dose (n=80) 12.6  (14.8)
Day 1, 4 hours post first dose (n=80) 17.4  (16.0)
Day 1, 6 hours post first dose (n=80) 19.6  (16.3)
Day 1, before sleep (n=80) 21.8  (16.8)
Day 2, on awakening (n=80) 25.1  (19.1)
Day 2, before sleep (n=80) 30.9  (20.8)
Day 3, on awakening (n=80) 35.1  (18.7)
Day 3, before sleep (n=78) 37.9  (18.8)
Day 4, on awakening (n=78) 41.3  (19.7)
Day 4, before sleep (n=73) 41.8  (19.2)
Day 5, on awakening (n=73) 44.3  (18.4)
Day 5, before sleep (n=68) 45.4  (19.5)
Day 6, on awakening (n=68) 48.0  (17.7)
Day 6, before sleep (n=68) 48.8  (18.1)
Day 7, on awakening (n=68) 49.2  (19.0)
Day 7, before sleep (n=55) 50.2  (18.7)
Day 8, on awakening (n=55) 51.3  (17.3)
Visit 3 (Day 8) (n=73) 52.4  (15.5)
Final Visit (LOCF, n=80) 52.6  (15.2)
6.Secondary Outcome
Title PID in Pain on Active Movement Within 8 Days Post-first Dose
Hide Description The PID score was obtained by subtracting the PI at each time point from the Baseline PI score. Increase in scores indicated a lessening of subjects' pain compared to baseline scores; higher scores indicated a greater reduction in pain.
Time Frame 2, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used.
Arm/Group Title Celecoxib
Hide Arm/Group Description:
Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2
Overall Number of Participants Analyzed 79
Mean (Standard Deviation)
Unit of Measure: mm
Day 1, 2 hours post first dose (n=77) 14.3  (16.6)
Day 1, 4 hours post first dose (n=77) 20.4  (17.1)
Day 1, 6 hours post first dose (n=77) 24.3  (17.5)
Day 1, before sleep (n=77) 26.5  (17.5)
Day 2, on awakening (n=77) 30.3  (19.2)
Day 2, before sleep (n=77) 36.1  (22.0)
Day 3, on awakening (n=77) 40.2  (21.2)
Day 3, before sleep (n=75) 43.2  (21.5)
Day 4, on awakening (n=75) 48.5  (22.3)
Day 4, before sleep (n=70) 49.5  (20.6)
Day 5, on awakening (n=70) 52.5  (20.8)
Day 5, before sleep (n=66) 53.5  (21.6)
Day 6, on awakening (n=66) 57.5  (19.7)
Day 6, before sleep (n=66) 58.4  (19.9)
Day 7, on awakening (n=66) 59.6  (21.4)
Day 7, before sleep (n=55) 62.1  (20.6)
Day 8, on awakening (n=55) 63.3  (20.6)
Visit 3 (Day 8) (n=71) 63.6  (18.6)
Final Visit (LOCF, n=78) 63.7  (18.1)
7.Secondary Outcome
Title Sum of Pain Intensity Differences (SPID) for Pain at Rest (Spontaneous Pain) and on Active Movement Until 6 Hours Post-first Dose
Hide Description The SPID was derived according to the following rule: each PID was weighted by the width of time interval between previous and current time points in hours and summed up to 6 hours post-first dose
Time Frame 6 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement. If a patient withdrew the study before 6 hours on Day 1 and the measurement of the PI at 6 hours on Day 1 was missing, the LOCF method was used for the PI at 6 hours on Day 1 to derive the SPID.
Arm/Group Title Celecoxib
Hide Arm/Group Description:
Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
Overall Number of Participants Analyzed 80
Mean (95% Confidence Interval)
Unit of Measure: mm
Pain at rest (n=80)
99.3
(79.9 to 118.7)
Pain on active movement (n=77)
118.2
(96.7 to 139.6)
8.Secondary Outcome
Title Peak Pain Intensity Difference (PPID) for Pain at Rest (Spontaneous Pain) and on Active Movement Until 6 Hours Post-first Dose
Hide Description The PPID was obtained by subtracting the maximum value of pain intensity (PI) at a time point among 2 to 6 hours post first dose from baseline value of PI for each patient.
Time Frame Two, 4 and 6 hours post first dose
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints.
Arm/Group Title Celecoxib
Hide Arm/Group Description:
Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
Overall Number of Participants Analyzed 80
Mean (95% Confidence Interval)
Unit of Measure: mm
Pain at rest (n=80)
22.2
(18.6 to 25.8)
Pain on active movement (n=77)
26.7
(22.6 to 30.7)
9.Secondary Outcome
Title Severity of Inflammatory Symptoms (Swelling) Within 8 Days Post-first Dose
Hide Description The investigator assessed the swelling, using the categories “None,” “Mild,” “Moderate,” and “Severe” at Baseline, Visit 2 (Day 4), Visit 3 (Day 8) and Final Visit.
Time Frame Baseline, Days 4 (Visit 2) and 8 (Visit 3)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used.
Arm/Group Title Celecoxib
Hide Arm/Group Description:
Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
Overall Number of Participants Analyzed 80
Measure Type: Number
Unit of Measure: Participants
None at Baseline (n=80) 0
None at Visit 2 (Day 4) (n=80) 5
None at Visit 3 (Day 8) (n=68) 38
None at Final Visit (n=80) 41
Mild at Baseline (n=80) 24
Mild at Visit 2 (Day 4) (n=80) 69
Mild at Visit 3 (Day 8) (n=68) 26
Mild at Final Visit (n=80) 35
Moderate at Baseline (n=80) 48
Moderate at Visit 2 (Day 4) (n=80) 5
Moderate at Visit 3 (Day 8) (n=68) 4
Moderate at Final Visit (n=80) 4
Severe at Baseline (n=80) 8
Severe at Visit 2 (Day 4) (n=80) 1
Severe at Visit 3 (Day 8) (n=68) 0
Severe at Final Visit (n=80) 0
10.Secondary Outcome
Title Severity of Inflammatory Symptoms (Redness) Within 8 Days Post-first Dose
Hide Description The investigator assessed the redness, using the categories “None,” “Mild,” “Moderate,” and “Severe” at Baseline, Visit 2 (Day 4), Visit 3 (Day 8) and Final Visit.
Time Frame Baseline, Days 4 (Visit 2) and 8 (Visit 3)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used.
Arm/Group Title Celecoxib
Hide Arm/Group Description:
Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2
Overall Number of Participants Analyzed 80
Measure Type: Number
Unit of Measure: Participants
None at Baseline (n=80) 16
None at Visit 2 (Day 4) (n=80) 51
None at Visit 3 (Day 8) (n=68) 64
None at Final Visit (n=80) 73
Mild at Baseline (n=80) 40
Mild at Visit 2 (Day 4) (n=80) 28
Mild at Visit 3 (Day 8) (n=68) 4
Mild at Final Visit (n=80) 7
Moderate at Baseline (n=80) 19
Moderate at Visit 2 (Day 4) (n=80) 1
Moderate at Visit 3 (Day 8) (n=68) 0
Moderate at Final Visit (n=80) 0
Severe at Baseline (n=80) 5
Severe at Visit 2 (Day 4) (n=80) 0
Severe at Visit 3 (Day 8) (n=68) 0
Severe at Final Visit (n=80) 0
11.Secondary Outcome
Title Severity of Inflammatory Symptoms (Localized Warmth) Within 8 Days Post First Dose
Hide Description The investigator assessed the localized warmth, using the categories “None,” “Mild,” “Moderate,” and “Severe” at Baseline, Visit 2 (Day 4), Visit 3 (Day 8) and Final Visit.
Time Frame Baseline, Days 4 (Visit 2) and 8 (Visit 3)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the LOCF was used.
Arm/Group Title Celecoxib
Hide Arm/Group Description:
Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2
Overall Number of Participants Analyzed 80
Measure Type: Number
Unit of Measure: Participants
None at Baseine (n=80) 8
None at Visit 2 (Day 4) (n=80) 63
None at Visit 3 (Day 8) (n=68) 66
None at Final Visit (n=80) 76
Mild at Baseine (n=80) 43
Mild at Visit 2 (Day 4) (n=80) 17
Mild at Visit 3 (Day 8) (n=68) 2
Mild at Final Visit (n=80) 4
Moderate at Baseine (n=80) 23
Moderate at Visit 2 (Day 4) (n=80) 0
Moderate at Visit 3 (Day 8) (n=68) 0
Moderate at Final Visit (n=80) 0
Severe at Baseine (n=80) 6
Severe at Visit 2 (Day 4) (n=80) 0
Severe at Visit 3 (Day 8) (n=68) 0
Severe at Final Visit (n=80) 0
12.Secondary Outcome
Title Withdrawal Due to Lack of Efficacy
Hide Description The number of subjects who withdrew due to insufficient clinical response was evaluated.
Time Frame 8 days
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints.
Arm/Group Title Celecoxib
Hide Arm/Group Description:
Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
Overall Number of Participants Analyzed 80
Measure Type: Number
Unit of Measure: Participants
0
13.Secondary Outcome
Title Summary of Adverse Events
Hide Description The number of subjects who experienced adverse events (AEs; all-causality and treatment-related) based on safety assessment was summarized. The severity and seriousness of treatment-emergent AEs as well as discontinuations, dose reductions and temporary discontinuations (DR/TD) due to treatment-emergent AEs were also summarized.
Time Frame 8 days
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set consisted of all patients who had taken at least one study medication.
Arm/Group Title Celecoxib
Hide Arm/Group Description:
Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
Overall Number of Participants Analyzed 80
Measure Type: Number
Unit of Measure: Participants
AEs: all-causality 10
AEs: treatment-related 8
Severe AEs: all-causality 0
Severe AEs: treatment-realted 0
Serious AEs: all-causality 0
Serious AEs: treatment-related 0
Discontinuation due to all-causality AEs 1
Discontinuation due to treatment-related AEs 1
DR/TD due to all-causality AEs 0
DR/TD due to treatment-related AEs 0
Time Frame 8 days
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Celecoxib
Hide Arm/Group Description Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
All-Cause Mortality
Celecoxib
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Celecoxib
Affected / at Risk (%)
Total   0/80 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Celecoxib
Affected / at Risk (%)
Total   10/80 (12.50%) 
Gastrointestinal disorders   
Diarrhoea  1  1/80 (1.25%) 
Injury, poisoning and procedural complications   
Muscle strain  1  1/80 (1.25%) 
Investigations   
Alanine aminotransferase increased  1  1/80 (1.25%) 
Aspartate aminotransferase increased  1  1/80 (1.25%) 
Beta 2 microglobulin urine increased  1  5/80 (6.25%) 
Beta-N-acetyl-D-glucosaminidase increased  1  3/80 (3.75%) 
Blood bilirubin increased  1  1/80 (1.25%) 
Blood creatine phosphokinase increased  1  3/80 (3.75%) 
Blood lactate dehydrogenase increased  1  2/80 (2.50%) 
Urobilin urine present  1  1/80 (1.25%) 
Skin and subcutaneous tissue disorders   
Eczema  1  1/80 (1.25%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
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
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00976716     History of Changes
Other Study ID Numbers: A3191357
First Submitted: September 11, 2009
First Posted: September 14, 2009
Results First Submitted: October 25, 2010
Results First Posted: May 19, 2011
Last Update Posted: May 19, 2011