Comparison · NCT00830167-ee461308
Pregabalin vs Placebo: Medical Outcomes Study (MOS) Sleep Scale - Number of Participants With Optimal Sleep at Endpoint
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Pregabalin vs Placebo: Medical Outcomes Study (MOS) Sleep Scale - Number of Participants With Optimal Sleep at Endpoint. Trial comparisons, record NCT00830167-ee461308. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00830167-ee461308
On this page
Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.285 | 0.233 | 0.344 | wilson | |
| Risk in group 2 | 0.215 | 0.168 | 0.27 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0706 | -0.00572 | 0.146 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.33 | 0.975 | 1.81 | log | |
| Odds ratio, group 1 over group 2 | 1.46 | 0.969 | 2.2 | log | |
| Number needed to treat, for one more participant with the outcome on Pregabalin than on Placebo | 14.2 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Pregabalin | Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant's individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase. | 71 | 249 | OG001 |
| Group 2 | Placebo | Placebo was administered twice a day for 15 weeks. | 53 | 247 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Medical Outcomes Study (MOS) Sleep Scale - Number of Participants With Optimal Sleep at Endpoint
- Description
MOS-Sleep is a patient-rated questionnaire to assess sleep quality and quantity. Optimal sleep component is derived from Sleep Quantity average hours of sleep each night during the past 4 weeks. Optimal sleep was defined as sleep quantity of 7 or 8 hours per night.
- Time frame
- Week 15 or study discontinuation
- Population
The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
Source ClinicalTrials.gov
Trial
- Title
- Randomized, Double-Blind, Placebo-Controlled Study Of Pregabalin In Patients With Fibromyalgia
- NCT number
- NCT00830167
- Phases
- PHASE3
- Conditions
- Fibromyalgia
- Interventions
- Placebo, Pregabalin
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Results first posted
- 2012-06-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00830167?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT00830167-ee461308