Trial · NCT02031432
Outcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment Emergent Adverse Event (TEAEs) | Up to 28 weeks (26 weeks of cebranopadol treatment and 2 weeks follow up after the last dose) | Safety Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Intensity of Treatment Emergent Adverse Events | Up to 28 weeks (26 weeks of cebranopadol treatment and 2 weeks follow-up after the last dose) | Safety Set; event-based analysis | Number of TEAEs | NUMBER |
| SECONDARY | Changes From Baseline in the Average Pain Intensity in the Last Week During the Treatment Period | Baseline Visit (Day 1) to End of Treatment Visit (up to 26 weeks). | Safety Set - participants with data available | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Outcome of Treatment Emergent Adverse Events (TEAE) | Baseline (Day 2) to End of trial (i.e., up to Week 28) | Safety Set; event-based analysis | Number of TEAEs | NUMBER |
| OTHER_PRE_SPECIFIED | Time to Onset of Treatment Emergent Adverse Events (TEAEs) | Baseline (Day 2) to End of trial (up to Week 28) | Safety Set; event-based analysis for 661 TEAEs. | days | MEDIAN |
| OTHER_PRE_SPECIFIED | Duration of Treatment Emergent Adverse Events (TEAEs) | Baseline (Day 2) to End of trial (up to Week 28) | Safety Set; data available for 373 TEAEs (duration data for 288 of 661 TEAEs were not available) | days | MEDIAN |
| OTHER_PRE_SPECIFIED | Causal Relationship of Treatment Emergent Adverse Events (TEAEs) | Baseline (Day 2) to End of trial (up to Week 28) | Safety Set; event-based analysis on 661 TEAEs | Number of TEAEs | NUMBER |
| OTHER_PRE_SPECIFIED | Countermeasures Taken for Treatment Emergent Adverse Events (TEAEs) | Baseline (Day 2) to End of trial (up to Week 28) | Safety Set; event-based analysis. | Number of TEAEs | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Related to Cebranopadol | Baseline (Day 2) to End of trial (up to Week 28) | Safety Set | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Columbia-Suicide Severity Rating Scale (C-SSRS) Scores | Baseline (Day 1) to End of trial (up to Week 28) | Safety Set | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Mean Scores of Chronic Pain Sleep Inventory (CPSI) and Changes From Baseline | Baseline (Day 1); End of Treatment (up to Week 26) | Safety Set; participants with data available at respective time point. | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Weekly Means of Daily Average Pain Intensity During the First Month of Treatment | Baseline (Day 1); Titration Weeks 1 and 2; Maintenance Weeks 1 and 2 | Safety Set; data for participants who completed respective visit. | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Worst Pain Intensity in the Last Week of Treatment (Week 26) | Baseline (Day 1); End of Treatment (Week 26) | Safety Set; 59 participants completed End of Treatment Visit | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Weekly Average Number of Breakthrough Pain Episodes | Baseline (Day 1); End of Treatment (Week 26) | Safety Set; 61 participants completed End of Treatment Visit | Weekly average number of episodes | MEDIAN |
| OTHER_PRE_SPECIFIED | Mean Scores of Neuropathic Pain Symptom Inventory (NPSI) | Baseline (Day 1); Weeks 2, 6, 14, 18; End of Treatment (up to Week 26) | Safety Set (21 participants with neuropathic pain of 76 participants enrolled) | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | EuroQol-5 Dimension (EQ-5D) Health Status Index Outcome | Baseline (Day 1); End of Treatment (up to Week 26) | Safety Set; participants with data available at respective time point. | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | EuroQol-5 Dimension (EQ-5D) Health Questionnaire - Visual Analog Scale (VAS) | Baseline (Day 1); End of Treatment (up to Week 26) | Safety Set; participants with data available at respective time point. | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Patient Global Impression of Change (PGIC) | Baseline (Day 1); End of Treatment (up to Week 26) | Safety Set; 62 participants completed the End of Treatment Visit. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Clinical Global Impression of Change (CGIC) | Baseline (Day 1); End of Treatment Visit (up to Week 26) | Safety Set; 62 participants completed the End of Treatment Visit. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Use of On-demand Opioid Analgesic Medication | From Day 3 to End of Treatment (up to Week 26) (13 time points) | Safety Set; participants with data available at the respective visit. | units | MEAN |
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/NCT02031432/outcomes