Fibromyalgia
Conditions
Brief summary
The purpose of this study is to evaluate if DVS SR is safe and effective in the treatment of pain associated with fibromyalgia syndrome, and if so to identify the efficacious doses.
Interventions
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Fibromyalgia diagnosed according to 1990 American College of Rheumatology criteria
Exclusion criteria
* Unstable medical or psychological conditions that would compromise the subject's safety or put the subject at greater risk during study participation * Other painful conditions that may confound the diagnosis or assessment of fibromyalgia * Treatment with other drugs for fibromyalgia with 14 days of study start or during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline on the Numeric Rating Scale (NRS) | Baseline and 8 weeks | The primary efficacy variable was the change from baseline on the NRS. The primary time point was the average pain score during the last data-analysis-interval of week 8. The baseline score was the average of the NRS scores across the last 7 days of the screening period (just prior to the start of the placebo run-in). The primary efficacy variable was the pain severity score measured on an 11 point NRS on which 0=no pain and 10=worst possible pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline on the Numeric Rating Scale (NRS) in the Treatment of Pain Associated With Fibromyalgia in Adult Female Outpatients | Baseline and 8 weeks | The efficacy variable was the change from baseline on the numeric rating scale (NRS). The time point was the average pain score during the last data-analysis-interval of week 8, data analysis interval. The baseline score was the average of the NRS scores across the last 7 days of the screening period (just prior to the start of the placebo run-in). The efficacy variable was the pain severity score measured on an 11 point NRS on which 0=no pain and 10=worst possible pain. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited in the United States from June 2006 to November 2008.
Pre-assignment details
After a 7 to 30 day screening period, eligible subjects entered a 7 day single blind placebo run-in period during which placebo responses were assessed.
Participants by arm
| Arm | Count |
|---|---|
| Placebo In the first stage, subjects were randomly assigned to receive placebo. Study was stopped after stage 1 by sponsor. | 40 |
| DVS SR In the first stage, subjects were randomly assigned to receive DVS SR 200 mg/day. Study was stopped after stage 1 by sponsor. | 42 |
| Pregabalin In the first stage, subjects were randomly assigned to receive Pregabalin 450 mg/day. Study was stopped after stage 1 by sponsor. | 43 |
| Total | 125 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 6 |
| Overall Study | Discontinuation by Sponsor | 9 | 13 | 14 |
| Overall Study | Failed to return | 1 | 3 | 1 |
| Overall Study | Lack of Efficacy | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 4 | 0 | 3 |
| Overall Study | Withdrawal by Subject | 0 | 3 | 2 |
Baseline characteristics
| Characteristic | Placebo | DVS SR | Pregabalin | Total |
|---|---|---|---|---|
| Age Continuous | 46.90 years STANDARD_DEVIATION 12.65 | 47.83 years STANDARD_DEVIATION 10.53 | 45.42 years STANDARD_DEVIATION 12.11 | 46.70 years STANDARD_DEVIATION 11.74 |
| Sex: Female, Male Female | 40 Participants | 42 Participants | 43 Participants | 125 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 25 / 40 | 25 / 42 | 32 / 43 |
| serious Total, serious adverse events | 0 / 40 | 0 / 42 | 1 / 43 |
Outcome results
Primary
Change From Baseline on the Numeric Rating Scale (NRS)
The primary efficacy variable was the change from baseline on the NRS. The primary time point was the average pain score during the last data-analysis-interval of week 8. The baseline score was the average of the NRS scores across the last 7 days of the screening period (just prior to the start of the placebo run-in). The primary efficacy variable was the pain severity score measured on an 11 point NRS on which 0=no pain and 10=worst possible pain.
Time frame: Baseline and 8 weeks
Population: The Modified Intent to Treat (MITT) population included all randomized subjects who had taken at least one dose of double-blind test article, who had a baseline primary efficacy evaluation, and who had at least one primary efficacy evaluation on double-blind therapy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline on the Numeric Rating Scale (NRS) | -1.98 units on scale | Standard Error 0.37 |
| DVS SR | Change From Baseline on the Numeric Rating Scale (NRS) | -1.60 units on scale | Standard Error 0.37 |
| Pregabalin | Change From Baseline on the Numeric Rating Scale (NRS) | -1.70 units on scale | Standard Error 0.38 |
p-value: 0.47195% CI: [-1.42, 0.66]ANCOVA
p-value: 0.60495% CI: [-1.33, 0.77]ANCOVA
Secondary
Change From Baseline on the Numeric Rating Scale (NRS) in the Treatment of Pain Associated With Fibromyalgia in Adult Female Outpatients
The efficacy variable was the change from baseline on the numeric rating scale (NRS). The time point was the average pain score during the last data-analysis-interval of week 8, data analysis interval. The baseline score was the average of the NRS scores across the last 7 days of the screening period (just prior to the start of the placebo run-in). The efficacy variable was the pain severity score measured on an 11 point NRS on which 0=no pain and 10=worst possible pain.
Time frame: Baseline and 8 weeks
Population: All randomized subjects who had taken at least one dose of double-blind test article, had a baseline primary efficacy evaluation, and had at least one primary efficacy evaluation on double-blind therapy. Subjects who did not complete the study due to its discontinuation were excluded.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline on the Numeric Rating Scale (NRS) in the Treatment of Pain Associated With Fibromyalgia in Adult Female Outpatients | -2.00 units on scale | Standard Error 0.37 |
| DVS SR | Change From Baseline on the Numeric Rating Scale (NRS) in the Treatment of Pain Associated With Fibromyalgia in Adult Female Outpatients | -1.64 units on scale | Standard Error 0.39 |
| Pregabalin | Change From Baseline on the Numeric Rating Scale (NRS) in the Treatment of Pain Associated With Fibromyalgia in Adult Female Outpatients | -1.45 units on scale | Standard Error 0.4 |
p-value: 0.5195% CI: [-1.42, 0.71]ANCOVA
p-value: 0.31795% CI: [-1.64, 0.54]ANCOVA