Trial · NCT01496365
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline to Week 5 in Average Daily Pain Score (ADPS) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Baseline up to Week 5 postdose, up to 10 months total follow up | ADPS was assessed in the Full Analysis Set. | units on a scale | MEAN |
| SECONDARY | Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Baseline up to Week 5 postdose, up to 10 months total follow up | ADPS was assessed in the Full Analysis Set. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Average Daily Pain Score Responder Rates Based on ≥30% and ≥50% Decrease From Baseline at Endpoint) Following Treatment With DS-5565 or Placebo Compared to Pregabalin | Baseline up to Week 5 postdose, up to 10 months total follow up | ADPS was assessed in the Full Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Change From Baseline to End-of-Treatment in Average Daily Sleep Interference Score Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Baseline up to Week 5 postdose, up to 10 months total follow up | ADSIS was assessed in the Full Analysis Set. | units on a scale | MEAN |
| SECONDARY | Short-Form McGill Pain Questionnaire (SF-MPQ) Sensory and Affective Scores Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Baseline up to Week 5 postdose, up to 10 months total follow up | SF-MPQ sensory and affective scores were assessed in the Full Analysis Set. | units on a scale | MEAN |
| SECONDARY | Short-Form McGill Pain Questionnaire (SF-MPQ) Total Score and Visual Analog Scale Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Baseline up to Week 5 postdose, up to 10 months total follow up | SF-MPQ total score and VAS pain were assessed in the Full Analysis Set. | units on a scale | MEAN |
| SECONDARY | Short-Form McGill Pain Questionnaire (SF-MPQ) Present Pain Intensity Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Baseline up to Week 5 postdose, up to 10 months total follow up | SF-MPQ present pain intensity was assessed in the Full Analysis Set. | units on a scale | MEAN |
| SECONDARY | Mean Change From Baseline to Endpoint of Modified Brief Pain Inventory (BPI) Subscale, Interference With Daily Functions, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Baseline up to Week 5 postdose, up to 10 months total follow up | Modified BPI was assessed in the Full Analysis Set. | units on a scale | MEAN |
| SECONDARY | Mean Change From Baseline to Endpoint of Modified BPI Subscales, Worst, Least and Average Pain Intensity, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Baseline up to Week 5 postdose, up to 10 months total follow up | Modified BPI was assessed in the Full Analysis Set. | units on a scale | MEAN |
| SECONDARY | Mean Change From Baseline to Endpoint of Modified BPI Subscale, Pain Right Now, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Baseline up to Week 5 postdose, up to 10 months total follow up | Modified BPI was assessed in the Full Analysis Set. | units on a scale | MEAN |
| SECONDARY | Mean Change From Baseline to Endpoint of Modified BPI Subscale, Relief From Pain, Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Baseline up to Week 5 postdose, up to 10 months total follow up | Modified BPI was assessed in the Full Analysis Set. | score on a scale | MEAN |
| SECONDARY | Patient Global Impression of Change at End-of-Treatment or Early Termination Following Treatment With DS-5565 Compared to Pregabalin and Placebo | Baseline up to Week 5 postdose, up to 10 months total follow up | PGIC was assessed in the Full Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo | From the time of signing the informed consent form (ICF) up to 10 months postdose | Safety events were assessed in the Safety Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
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.
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GET https://conductscience.org/api/trials/v1/NCT01496365/outcomes