Trial · NCT01533428
Outcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 8 | Baseline to between Weeks 2 to 8 | Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used. | percentage change | MEAN |
| SECONDARY | Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 12 | Baseline to between Weeks 2 and 12 | Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used. | percentage change | MEAN |
| SECONDARY | Weekly Percent Change From Baseline in Average Daily Pain Score | Baseline to Weeks 2, 3, 4, 5, 6, 7, 8, 9,10, 11 and 12 | Intention to Treat (ITT ); Baseline last observation carried forward (BLOCF) imputation was used. | percentage change | MEAN |
| SECONDARY | Weekly Average of Average Daily Pain at Baseline and Every Week After Baseline | Baseline and Weeks 2, 4, 8 and 12 | Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used. | units on a scale | MEAN |
| SECONDARY | Percentage of Participants With 30% Reduction in Average Daily Pain Score. | Baseline, Weeks 2-8 and Weeks 2-12 | Intention to Treat (ITT ); Baseline last observation carried forward(BLOCF) imputation was used. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With 50% Reduction in Average Daily Pain Score. | Baseline, Weeks 2-8 and Weeks 2-12 | Intention to Treat (ITT ); Baseline last observation carried forward(BLOCF) imputation was used. | percentage of participants | NUMBER |
| SECONDARY | Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 2 | Baseline to Week 2 | Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used. | participants | NUMBER |
| SECONDARY | Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 8 | Baseline to Week 8 | Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used. | participants | NUMBER |
| SECONDARY | Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 12 | Baseline to Week 12 | Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used. | participants | NUMBER |
| SECONDARY | Change From Baseline in the European Quality Of Life (QOL) Questionnaire in 5 Dimensions (EQ-5D) With Visual Analog Scale (VAS) to Weeks 2, 8 and 12 | Baseline to Weeks 2, 8 and 12 | Intention to Treat (ITT); Baseline and Last Observation Carried Forward (BLOCF) imputation was used. | units on a scale | MEAN |
| SECONDARY | Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Scale From Baseline to Weeks 2, 8 and 12 | Baseline to Weeks 2, 8 and 12 | Intention to Treat (ITT); Baseline and Last Observation Carried Forward (BLOCF) imputation was used. | units on a scale | MEAN |
| SECONDARY | Change in Hospital Anxiety and Depression Scale (HADS) Depression Scale From Baseline to Weeks 2, 8 and 12. | Baseline to Weeks 2, 8 and 12 | Intention to Treat (ITT); Baseline and Last Observation Carried Forward (BLOCF) imputation was used. | units on a scale | MEAN |
| SECONDARY | Treatment Satisfaction Assessment Based on Self-Assessment of Treatment (SAT II) Questionnaire at Baseline, Weeks 8 and 12 | Baseline, Weeks 8 and 12 | Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used. | participants | NUMBER |
| SECONDARY | Percent Change in Average Sleep Interference Score From Baseline to Between Weeks 2-8 and Weeks 2-12 | Baseline, Weeks 2-8 and Weeks 2-12 | Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used. | percentage of change | MEAN |
| SECONDARY | Tolerability of Patch Application Assessed by Dermal Assessment on Day 1, 15 Minutes and 60 Minutes After Patch Removal. | Day 1, 15 minutes and 60 minutes after patch removal | Safety Analysis Set (SAF) | participants | NUMBER |
| SECONDARY | Change From Pre-application inPain Now Score | Pre-application and 15 minutes and 60 minutes after patch removal | Safety Analysis Set (SAF) | units on a scale | MEAN |
| SECONDARY | Number of Participants Who Used Rescue Pain Medication Days 1 Through 5 | Days 1 - 5 | Safety Analysis Set (SAF) | participants | NUMBER |
| SECONDARY | Safety Assessed Through Adverse Events (AE) and Serious Adverse Events (SAE), Vital Signs, and Laboratory Analyses From Baseline to Week 12 | Baseline to Week 12 | Safety Analysis Set (SAF) | participants | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01533428/outcomes