Trial Outcomes & Findings for This Study is An Open-Label Trial Of Pregabalin In Patients With Fibromyalgia (NCT NCT00346034)

Last Updated: 2021-01-22

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

357 participants

Primary outcome timeframe

Week 4

Results posted on

2021-01-22

Participant Flow

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).

Following the termination visit in study A0081100, subjects had an option of starting pregabalin under open-label conditions the day after the termination visit.

Participant milestones

Participant milestones
Measure	Pregabalin 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 Study STARTED	357
Overall Study COMPLETED	300
Overall Study NOT COMPLETED	57

Reasons for withdrawal

Reasons for withdrawal
Measure	Pregabalin 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 Study Adverse Event	34
Overall Study Lack of Efficacy	8
Overall Study Withdrawal by Subject	13
Overall Study Patient Stopped Taking Study Drug	1
Overall Study Not Willing to Follow Dosing Regimen	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pregabalin n=357 Participants 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.
Age, Continuous	48.3 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	322 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 4

Population: This will include all patients who have received at least one dose of study medication and had observations at both baseline and week 4.

Outcome measures

Outcome measures
Measure	Pregabalin n=306 Participants 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.
Change From Baseline to Week 4 in Pain Visual Analog Scale (VAS) Score	-18.1 mm Standard Deviation 24.1

PRIMARY outcome

Timeframe: Week 12 (end of treatment)

Population: This will include all patients who have received at least one dose of study medication and observations at both baseline and week 12.

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.

Outcome measures

Outcome measures
Measure	Pregabalin n=335 Participants 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.
Change From Baseline to Week 12 in Pain Visual Analog Scale (VAS) Score	-20.1 mm Standard Deviation 26.8

Adverse Events

Pregabalin

Serious events: 6 serious events

Other events: 173 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pregabalin 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.
Gastrointestinal disorders Diarrhea	0.28% 1/357
Gastrointestinal disorders Melaena	0.28% 1/357
Gastrointestinal disorders Vomiting	0.28% 1/357
Infections and infestations Urinary tract infection	0.28% 1/357
Injury, poisoning and procedural complications Fall	0.28% 1/357
Injury, poisoning and procedural complications Wrist fracture	0.28% 1/357
Injury, poisoning and procedural complications Spinal osteoarthritis	0.28% 1/357
Nervous system disorders Myoclonus	0.28% 1/357
Reproductive system and breast disorders Vulva cyst	0.28% 1/357
Respiratory, thoracic and mediastinal disorders Epistaxis	0.28% 1/357

Other adverse events

Other adverse events
Measure	Pregabalin 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.
Nervous system disorders Dizziness	23.8% 85/357
Nervous system disorders Headache	9.2% 33/357
Nervous system disorders Somnolence	8.4% 30/357
Ear and labyrinth disorders Vertigo	3.4% 12/357
Gastrointestinal disorders Constipation	4.2% 15/357
Gastrointestinal disorders Dry mouth	3.9% 14/357
Gastrointestinal disorders Nausea	5.9% 21/357
Gastrointestinal disorders Vomiting	3.6% 13/357
General disorders Fatigue	6.7% 24/357
General disorders Oedema peripheral	3.4% 12/357
Infections and infestations Nasopharyngitis	3.1% 11/357
Investigations Weight increased	3.9% 14/357

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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
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Restriction type: OTHER