Comparison · NCT00748098-3e8ab7d0
GEn 1200 mg vs Placebo: Number of PLMAI Responders 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 PLMAI Responders at Week 4/10 Using LOCF. Trial comparisons, record NCT00748098-3e8ab7d0. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00748098-3e8ab7d0
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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 | 0.529 | 0.44 | 0.616 | wilson | |
| Risk in group 2 | 0.358 | 0.279 | 0.446 | wilson | |
| Risk difference, group 1 minus group 2 | 0.171 | 0.0465 | 0.289 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.48 | 1.11 | 1.98 | log | |
| Odds ratio, group 1 over group 2 | 2.02 | 1.21 | 3.37 | log | |
| Number needed to treat, for one more participant with the outcome on GEn 1200 mg than on Placebo | 5.84 | 3.46 | 21.5 | 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 | 64 | 121 | OG001 |
| Group 2 | Placebo | Placebo once daily either in first intervention period or second intervention period. | 44 | 123 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of PLMAI Responders at Week 4/10 Using LOCF
- Description
- PLMAI is defined as the number of PLMs associated with arousal per hour of sleep. Participants with \<=5 PLMAI were evaluated as responders.
- Time frame
- Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)
- Population
ITT Population: Of the 131 ITT participants, 2 and 6 participants did not take Placebo and GEn 1200 mg, respectively, in the second period. In addition, 6 placebo and 4 GEn 1200 participants did not have PSG data during the second intervention period and were therefore not included in this analysis.
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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