Comparison · NCT00617461-0dd8f29d
GEn 1200 mg vs GEn 3600 mg: Number of Participants Who Are Responders on the Patient Global Impression of Change (PGIC) at the Last Week of Each Treatment Period Using LOCF Data
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 GEn 3600 mg: Number of Participants Who Are Responders on the Patient Global Impression of Change (PGIC) at the Last Week of Each Treatment Period Using LOCF Data. Trial comparisons, record NCT00617461-0dd8f29d. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00617461-0dd8f29d
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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 | 0.27 | 0.176 | 0.39 | wilson | |
| Risk in group 2 | 0.459 | 0.34 | 0.583 | wilson | |
| Risk difference, group 1 minus group 2 | -0.189 | -0.345 | -0.0199 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.588 | 0.36 | 0.959 | log | |
| Odds ratio, group 1 over group 2 | 0.436 | 0.206 | 0.922 | log | |
| Number needed to treat, for one fewer participant with the outcome on GEn 1200 mg than on GEn 3600 mg | 5.29 | 2.9 | 50.2 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | GEn 1200 mg | GEn 1200 mg daily either in first intervention period or second intervention period | 17 | 63 | OG000 |
| Group 2 | GEn 3600 mg | GEn 3600 mg daily either in first intervention period or second intervention period | 28 | 61 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants Who Are Responders on the Patient Global Impression of Change (PGIC) at the Last Week of Each Treatment Period Using LOCF Data
- Description
The PGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the participant's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of very much improved or much improved Data are summarized by dose, independent of treatment period.
- Time frame
- End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)
- Population
ITT Population. There were 3 and 8 participants who did not take GEn 1200 and 3600 mg, respectively, in the second period. There were many participants who did not respond to the questionnaire and thus could not be included in the analysis.
Source ClinicalTrials.gov
Trial
- Title
- A Clinical Study in Subjects With Neuropathic Pain From PHN Who Have Had an Inadequate Response to Gabapentin Treatment
- NCT number
- NCT00617461
- Phases
- PHASE2
- Conditions
- Neuralgia, Postherpetic
- Interventions
- GEn 1200mg/day, GEn 3600mg/day
- Lead sponsor
- XenoPort, Inc.
- Results first posted
- 2011-05-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00617461?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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