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This Study is An Open-Label Trial Of Pregabalin In Patients With Fibromyalgia

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: NCT00346034
Recruitment Status : Completed
First Posted : June 29, 2006
Results First Posted : March 13, 2009
Last Update Posted : December 6, 2018
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 Fibromyalgia
Intervention Drug: Pregabalin
Enrollment 357
Recruitment Details The study was planned to include all eligible subjects continuing from the preceding double-blind study A0081100 NCT00333866 (Subjects had to be at least 18 years old and have met the American College of Rheumatology criteria for fibromyalgia).
Pre-assignment Details Following the termination visit in study A0081100, subjects had an option of starting pregabalin under open-label conditions the day after the termination visit.
Arm/Group Title Pregabalin
Hide Arm/Group Description Subjects began the open-label study (A0081101) medication the morning after termination visit from double-blind study (A0081100) at a fixed dose of 300 mg/day. Pregabalin daily dose was adjusted thereafter by the investigator to optimize pain control and to minimize adverse events. Adjustments to total daily doses were permitted for the remainder of the study. The minimum permissible daily dose was 150 mg/day (75 mg BID) and the maximum daily dose was 600 mg/day (300 mg BID) of pregabalin.
Period Title: Overall Study
Started 357
Completed 300
Not Completed 57
Reason Not Completed
Adverse Event             34
Lack of Efficacy             8
Withdrawal by Subject             13
Patient Stopped Taking Study Drug             1
Not Willing to Follow Dosing Regimen             1
Arm/Group Title Pregabalin
Hide Arm/Group Description Subjects began the open-label study (A0081101) medication the morning after termination visit from double-blind study (A0081100) at a fixed dose of 300 mg/day. Pregabalin daily dose was adjusted thereafter by the investigator to optimize pain control and to minimize adverse events. Adjustments to total daily doses were permitted for the remainder of the study. The minimum permissible daily dose was 150 mg/day (75 mg BID) and the maximum daily dose was 600 mg/day (300 mg BID) of pregabalin.
Overall Number of Baseline Participants 357
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 357 participants
48.3  (11.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 357 participants
Female
322
  90.2%
Male
35
   9.8%
1.Primary Outcome
Title Change From Baseline to Week 4 in Pain Visual Analog Scale (VAS) Score
Hide Description Mean Change: Observation VAS score minus Baseline score. Pain VAS: 100 mm horizontal line to rate (score) pain from 0 “no pain” to 100 “worst possible pain”. Baseline = value @ double-blind screening if randomized to pregabalin during double-blind or value @ last visit from double-blind if randomized to placebo during double-blind.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
This will include all patients who have received at least one dose of study medication and had observations at both baseline and week 4.
Arm/Group Title Pregabalin
Hide Arm/Group Description:
Subjects began the open-label study (A0081101) medication the morning after termination visit from double-blind study (A0081100) at a fixed dose of 300 mg/day. Pregabalin daily dose was adjusted thereafter by the investigator to optimize pain control and to minimize adverse events. Adjustments to total daily doses were permitted for the remainder of the study. The minimum permissible daily dose was 150 mg/day (75 mg BID) and the maximum daily dose was 600 mg/day (300 mg BID) of pregabalin.
Overall Number of Participants Analyzed 306
Mean (Standard Deviation)
Unit of Measure: mm
-18.1  (24.1)
2.Primary Outcome
Title Change From Baseline to Week 12 in Pain Visual Analog Scale (VAS) Score
Hide Description Mean Change: Observation VAS score minus Baseline score. Pain VAS is a 100mm horizontal line used to rate (score) pain by subject from 0 “no pain” to 100 “worst possible pain”. Baseline=value @ double-blind screening if randomized to pregabalin during double-blind OR value @ last visit from double-blind if randomized to placebo during double-blind.
Time Frame Week 12 (end of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
This will include all patients who have received at least one dose of study medication and observations at both baseline and week 12.
Arm/Group Title Pregabalin
Hide Arm/Group Description:
Subjects began the open-label study (A0081101) medication the morning after termination visit from double-blind study (A0081100) at a fixed dose of 300 mg/day. Pregabalin daily dose was adjusted thereafter by the investigator to optimize pain control and to minimize adverse events. Adjustments to total daily doses were permitted for the remainder of the study. The minimum permissible daily dose was 150 mg/day (75 mg BID) and the maximum daily dose was 600 mg/day (300 mg BID) of pregabalin.
Overall Number of Participants Analyzed 335
Mean (Standard Deviation)
Unit of Measure: mm
-20.1  (26.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pregabalin
Hide Arm/Group Description Subjects began the open-label study (A0081101) medication the morning after termination visit from double-blind study (A0081100) at a fixed dose of 300 mg/day. Pregabalin daily dose was adjusted thereafter by the investigator to optimize pain control and to minimize adverse events. Adjustments to total daily doses were permitted for the remainder of the study. The minimum permissible daily dose was 150 mg/day (75 mg BID) and the maximum daily dose was 600 mg/day (300 mg BID) of pregabalin.
All-Cause Mortality
Pregabalin
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pregabalin
Affected / at Risk (%)
Total   6 
Gastrointestinal disorders   
Diarrhea * 1  1/357 (0.28%) 
Melaena * 1  1/357 (0.28%) 
Vomiting * 1  1/357 (0.28%) 
Infections and infestations   
Urinary tract infection * 1  1/357 (0.28%) 
Injury, poisoning and procedural complications   
Fall * 1  1/357 (0.28%) 
Wrist fracture * 1  1/357 (0.28%) 
Spinal osteoarthritis * 1  1/357 (0.28%) 
Nervous system disorders   
Myoclonus * 1  1/357 (0.28%) 
Reproductive system and breast disorders   
Vulva cyst * 1  1/357 (0.28%) 
Respiratory, thoracic and mediastinal disorders   
Epistaxis * 1  1/357 (0.28%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, medDRA (v11.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Pregabalin
Affected / at Risk (%)
Total   173 
Ear and labyrinth disorders   
Vertigo * 1  12/357 (3.36%) 
Gastrointestinal disorders   
Constipation * 1  15/357 (4.20%) 
Dry mouth * 1  14/357 (3.92%) 
Nausea * 1  21/357 (5.88%) 
Vomiting * 1  13/357 (3.64%) 
General disorders   
Fatigue * 1  24/357 (6.72%) 
Oedema peripheral * 1  12/357 (3.36%) 
Infections and infestations   
Nasopharyngitis * 1  11/357 (3.08%) 
Investigations   
Weight increased * 1  14/357 (3.92%) 
Nervous system disorders   
Dizziness * 1  85/357 (23.81%) 
Headache * 1  33/357 (9.24%) 
Somnolence * 1  30/357 (8.40%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (v11.1)
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 <60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), <12 mo from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info 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.govCallCenter@pfizer.com
Layout table for additonal information
Responsible Party: Director, Clinical Trials Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00346034     History of Changes
Other Study ID Numbers: A0081101
First Submitted: June 28, 2006
First Posted: June 29, 2006
Results First Submitted: February 12, 2009
Results First Posted: March 13, 2009
Last Update Posted: December 6, 2018