Fibromyalgia
Conditions
Brief summary
The main purpose of this protocol is to evaluate the long-term safety of pregabalin in patients who participated in the previous fibromyalgia Study A0081100 and who wish to receive open-label pregabalin therapy.
Interventions
DRUGPregabalin
150 to 600mg/day
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must have met the inclusion criteria for the preceding fibromyalgia Protocol A0081100, and must have received pregabalin/placebo under double-blind conditions.
Exclusion criteria
* Patients may not participate in the study if they experienced a serious adverse event during the previous fibromyalgia Study A0081100 which was determined to be related to the study medication by the investigator or the sponsor.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 4 in Pain Visual Analog Scale (VAS) Score | Week 4 | 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. |
| Change From Baseline to Week 12 in Pain Visual Analog Scale (VAS) Score | Week 12 (end of treatment) | 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. |
Countries
Canada, Denmark, France, Germany, India, Italy, Netherlands, Portugal, South Korea, Sweden, Switzerland, United Kingdom
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 357 |
| Total | 357 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 34 |
| Overall Study | Lack of Efficacy | 8 |
| Overall Study | Not Willing to Follow Dosing Regimen | 1 |
| Overall Study | Patient Stopped Taking Study Drug | 1 |
| Overall Study | Withdrawal by Subject | 13 |
Baseline characteristics
| Characteristic | Pregabalin |
|---|---|
| Age, Continuous | 48.3 years STANDARD_DEVIATION 11.1 |
| Sex: Female, Male Female | 322 Participants |
| Sex: Female, Male Male | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 173 / — |
| serious Total, serious adverse events | 6 / — |
Outcome results
Primary
Change From Baseline to Week 12 in Pain Visual Analog Scale (VAS) Score
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)
Population: This will include all patients who have received at least one dose of study medication and observations at both baseline and week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Change From Baseline to Week 12 in Pain Visual Analog Scale (VAS) Score | -20.1 mm | Standard Deviation 26.8 |
Primary
Change From Baseline to Week 4 in Pain Visual Analog Scale (VAS) Score
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Change From Baseline to Week 4 in Pain Visual Analog Scale (VAS) Score | -18.1 mm | Standard Deviation 24.1 |