Comparison · NCT00748098-75d15fce
GEn 1200 mg vs Placebo: Number of Participants With no Self-reported Awakenings (SPSD) Due to RLS at Week 4/10 Using LOCF
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. GEn 1200 mg vs Placebo: Number of Participants With no Self-reported Awakenings (SPSD) Due to RLS at Week 4/10 Using LOCF. Trial comparisons, record NCT00748098-75d15fce. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00748098-75d15fce
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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 | 0.757 | 0.671 | 0.826 | wilson | |
| Risk in group 2 | 0.544 | 0.457 | 0.629 | wilson | |
| Risk difference, group 1 minus group 2 | 0.213 | 0.0919 | 0.324 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.39 | 1.15 | 1.68 | log | |
| Odds ratio, group 1 over group 2 | 2.6 | 1.5 | 4.53 | log | |
| Number needed to treat, for one more participant with the outcome on GEn 1200 mg than on Placebo | 4.71 | 3.09 | 10.9 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | GEn 1200 mg | GEn 1200 mg once daily either in first intervention period or second intervention period | 87 | 115 | OG001 |
| Group 2 | Placebo | Placebo once daily either in first intervention period or second intervention period | 68 | 125 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With no Self-reported Awakenings (SPSD) Due to RLS at Week 4/10 Using LOCF
- Description
Each day upon awakening, participants recorded, using the SPSD, the number of awakenings due to RLS they experienced the previous night. Number of awakenings was calculated for each visit by averaging the last 7 available diary days. Only participants with at least 4 days of diary data available (not in consecutive order) at any visit were included in the analysis.
- Time frame
- Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)
- Population
- ITT Population: The number of participants assessed varied due to missing/incomplete diary data.
Source ClinicalTrials.gov
Trial
- Title
- Polysomnography Study of GSK1838262 Extended Release Tablets Versus Placebo in RLS and Associated Sleep Disturbance
- NCT number
- NCT00748098
- Phases
- PHASE3
- Conditions
- Restless Legs Syndrome, Restless Legs Syndrome (RLS)
- Interventions
- GSK1838262 Extended Release Tablets, Placebo
- Lead sponsor
- XenoPort, Inc.
- Results first posted
- 2011-05-18
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00748098?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.
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