Trial · NCT01964378
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Average Amount of Daily Rescue Medication at the End of the Maintenance Period (Per Protocol Set) | The last 2 weeks of the expected 6-week treatment period. | The Per Protocol Set (PPS) describes a subset of subjects in the Full Analysis Set (FAS). The PPS included all allocated participants who completed at least 2 weeks of treatment in the maintenance phase and had no major protocol deviations relevant for efficacy evaluations. | milligram(s)/24 hours | LEAST_SQUARES_MEAN |
| PRIMARY | Average Amount of Daily Rescue Medication at the End of the Maintenance Period (Full Analysis Set) | The last 2 weeks of the expected 6-week treatment period. | The Full Analysis Set includes all allocated participants who took at least 1 dose of the investigational medicinal product (IMP) and had at least 1 day with information for the amount of rescue medication intake after the first intake of double-blind IMP (study drug). | milligram(s)/24 hours | LEAST_SQUARES_MEAN |
| SECONDARY | Proportion of Participants With Clinically Relevant Pain Reduction at the End of the Maintenance Period | The last 2 weeks of the expected 6-week treatment period. | Full Analysis Set (FAS). Clinically relevant pain reduction (Yes/No) in Maintenance Week 3 and Week 4. Missing data were imputed using a multiple imputation on the weekly average pain intensity. Participants that discontinued from the trial due to a lack of efficacy were classified as non-responders. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Change in Weekly Mean of the Daily Average Pain Intensity Score From Baseline | Baseline; last 2 weeks of the expected 6-week treatment period | Full Analysis Set (FAS) | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Response Rate to Treatment | Baseline; last 2 weeks of the expected 6-week treatment period | Full Analysis Set (FAS). Worsening in 24-hour pain or premature discontinuation due to lack of efficacy or Adverse Event was regarded a non-response, other missing data is imputed using last observation carried forward (LOCF). | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Overall Score of the Neuropathic Pain Symptom Inventory (NPSI) | Baseline; End-of-Treatment Visit (Week 6) | Subset of participants that were assessed to have Neuropathic Pain (using the DN4 questionnaire) at baseline. | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | EuroQol-5 Dimension (EQ-5D) Health Questionnaire: Weighted EQ-5D Health Status Index | Baseline; End-of-Treatment Visit (6 weeks) | Full Analysis Set; means (standard deviations) are presented for the number of participants at the End-of-Treatment Visit with respective data available. | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | EuroQol-5 Dimension (EQ-5D) Health Questionnaire: Visual Analog Scale (VAS) Score | Baseline; End-of-Treatment Visit (6 weeks) | Full Analysis Set; means (standard deviations) are presented for the number of participants at the End-of-Treatment Visit with respective data available. | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Change in the Physical and Mental Component Scores From the Short Form 12® Health Survey (SF-12) | Baseline; End-of-Treatment Visit (6 weeks) | Full Analysis Set (FAS). End of Treatment (End of Maintenance Period Visit). | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Patient Global Impression of Change (PGIC) | Baseline; End-of-Treatment Visit (6 weeks) | Full Analysis Set (FAS). End of Treatment (End of Maintenance Period Visit). Participants with data available. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Clinical Global Impression of Change (CGIC) | Baseline; End-of-Treatment Visit (6 weeks) | Full Analysis Set (FAS). End of Treatment (End of Maintenance Period Visit). Participants with data available. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Overall Score of the Patient Assessment of Constipation Symptoms (PAC-SYM) | Baseline; End-of-Treatment Visit (6 weeks) | Safety Set; number of participants with data available. | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Change in Weekly Mean of the Daily Worst Pain Intensity Score From Baseline | Baseline; End-of-Treatment Visit (6 weeks) | Full analysis set (FAS) | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline to End-of-Treatment Visit in Chronic Pain Sleep Inventory (CPSI) Scores | Baseline; End-of-Treatment Visit (6 weeks) | Full Analysis Set | units on a scale | 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/NCT01964378/outcomes