Comparison · NCT00748098-6eb5b57b
GEn 1200 mg vs Placebo: Number of Participants Who Were Defined as Clinical Global Impression of Illness (CGI-I) Scale 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 Participants Who Were Defined as Clinical Global Impression of Illness (CGI-I) Scale Responders at Week 4/10 Using LOCF. Trial comparisons, record NCT00748098-6eb5b57b. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00748098-6eb5b57b
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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 | 0.74 | 0.656 | 0.809 | wilson | |
| Risk in group 2 | 0.362 | 0.284 | 0.449 | wilson | |
| Risk difference, group 1 minus group 2 | 0.378 | 0.257 | 0.482 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.04 | 1.59 | 2.63 | log | |
| Odds ratio, group 1 over group 2 | 5.01 | 2.91 | 8.61 | log | |
| Number needed to treat, for one more participant with the outcome on GEn 1200 mg than on Placebo | 2.65 | 2.07 | 3.89 | 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 | 91 | 123 | OG001 |
| Group 2 | Placebo | Placebo once daily either in first intervention period or second intervention period. | 46 | 127 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants Who Were Defined as Clinical Global Impression of Illness (CGI-I) Scale Responders at Week 4/10 Using LOCF
- Description
The CGI-I scale allows the investigator to rate the participant's global improvement or worsening compared with the condition at baseline (i.e., Day 1), and whether or not the change is thought to be due to treatment with study medication. The scale is rated from 1-7 (1=Very much improved to 7=Very much worse). Participants with a score of 1 (Very much improved) or 2 (Much improved) are considered to be responders.
- 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 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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