Comparison · NCT01711021-0e38dd33
d-Amphetamine Transdermal Patch vs Placebo Patch: Number of Responders Evaluated by Clinical Global Impression (CGI-I) Scale by Treatments From the Double-blind Treatment Period
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. d-Amphetamine Transdermal Patch vs Placebo Patch: Number of Responders Evaluated by Clinical Global Impression (CGI-I) Scale by Treatments From the Double-blind Treatment Period. Trial comparisons, record NCT01711021-0e38dd33. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01711021-0e38dd33
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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 | 0.84 | 0.758 | 0.897 | wilson | |
| Risk in group 2 | 0.236 | 0.165 | 0.325 | wilson | |
| Risk difference, group 1 minus group 2 | 0.604 | 0.483 | 0.695 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3.56 | 2.5 | 5.07 | log | |
| Odds ratio, group 1 over group 2 | 17 | 8.54 | 33.7 | log | |
| Number needed to treat, for one more participant with the outcome on d-Amphetamine Transdermal Patch than on Placebo Patch | 1.66 | 1.44 | 2.07 | 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 | d-Amphetamine Transdermal Patch | Subjects who reached the optimal dose by end of dose optimization treatment period were randomized to receive double-blind treatment.~Participants first received study patches everyday for one week, then subjects were crossed-over to receive the placebo treatment.~d-Amphetamine Transdermal System: Patches will be worn for 9 hours every day. After 9 hours the patch will be removed. Every day a new patch will be applied. | 89 | 106 | OG000 |
| Group 2 | Placebo Patch | Subjects who reached the optimal dose by end of dose optimization treatment period were randomized to receive double-blind treatment.~Participants first received placebo patches everyday for one week, then subjects were crossed-over to receive the study treatment.~Placebo patch: Patches will be worn for 9 hours every day. After 9 hours the patch will be removed. Every day a new patch will be applied. | 25 | 106 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Responders Evaluated by Clinical Global Impression (CGI-I) Scale by Treatments From the Double-blind Treatment Period
- Description
The CGI scale permits a global evaluation of the subject's improvement over time. During the Dose Optimization Period and the Double-Blind Treatment Period, the investigator assessed the subject's improvement relative to symptoms prior to dosing, using the CGI-I Scale.~For CGI-I scale, the responders are defined as subjects achieving a score of~1. Very much improved or~2. Much improved or~ The non-responders are defined as subjects achieving a score of~3. Minimally improved on the clinician-rated CGI global improvement item or~4. No change or~5. Minimally worse or~6. Much worse or~7. Very much worse~Then the number of responders are calculated by treatment arms. Note: Week 6 is the first week of the double-blind treatment period, week 7 is the second week of the double-blind treatment period.
- Time frame
- the double-blind treatment period
- Population
Responder includes the categories Very Much Improved and Much Improved; Non-Responder includes all other categories, with the exception of not assessed which has been considered missing data.~Note: the Full Analysis Set is 106 (N)
Source ClinicalTrials.gov
Trial
- Title
- Study to Evaluate Safety & Efficacy of d-Amphetamine Transdermal System vs Placebo in Children & Adolescents With ADHD
- NCT number
- NCT01711021
- Phases
- PHASE2
- Conditions
- Attention Deficit Hyperactivity Disorder
- Interventions
- d-Amphetamine Transdermal Patch, Placebo patch
- Lead sponsor
- Noven Pharmaceuticals, Inc.
- Results first posted
- 2023-12-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01711021?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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