Trial · NCT00785577
Outcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Weekly Mean 24-hour Average Pain Severity (APS) Score at 5 Weeks | Baseline, 5 weeks | The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure. Last observation carried forward (LOCF) was conducted on the primary efficacy measure modified ITT population. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Weekly Mean Night Pain Severity Score at 5 Weeks | Baseline, 5 weeks | The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Weekly Mean Worst Daily Pain Severity Score at 5 Weeks | Baseline, 5 weeks | The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With 30% Reduction in Weekly Mean 24-hour Average Pain Severity (APS) Score | Baseline through 5 weeks | The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure. LOCF was conducted on the primary efficacy measure modified ITT population. | participants | NUMBER |
| SECONDARY | Change From Baseline in Average Brief Pain Inventory - Interference (BPI-I) Subscale Score at 5 Weeks | Baseline, 5 weeks | The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Brief Pain Inventory - Severity (BPI-S) Subscale Score at 5 Weeks | Baseline, 5 weeks | The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 5 Weeks | Baseline, 5 weeks | The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Patient Global Impression of Improvement (PGI-I) Score at 5 Weeks | Week 5 | The analysis population was a modified intent to treat (ITT) population defined as participants who received either study drug with only postbaseline data collected. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Short-form McGill Pain Questionnaire (SF-MPQ) Sensory Subscale Score at 5 Weeks | Baseline, 5 weeks | The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Assessment of Sleep Questionnaire (ASQ) Total Score at 5 Weeks | Baseline, 5 weeks | The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Neuropathy-Specific Quality of Life (NeuroQoL) Questionnaire Score at 5 Weeks | Baseline, 5 weeks | The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Short Form-36 (SF-36) Health Survey Bodily Pain Score at 5 Weeks | Baseline, 5 weeks | The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline of European Quality of Life Scale - 5 Dimensions (EQ-5D) at 5 Weeks: United States Population Based Index Score | Baseline, 5 weeks | The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Sheehan Disability Scale (SDS) Global Impairment Score at 5 Weeks | Baseline, 5 weeks | The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants Who Discontinued Due to Adverse Events (AEs) During the Therapy (Double-blind) Phase and 1-Week Washout (Follow-up) Phase | Baseline through 6 weeks | The safety analysis population included all 273 participants randomized to study drug. | participants | NUMBER |
| SECONDARY | Number of Participants With Serious Treatment Emergent Abnormal High or Low Laboratory Values | Baseline through 5 weeks | The safety analysis population included all 273 participants randomized to study drug. | participants | NUMBER |
| SECONDARY | Change From Baseline in Vital Signs: Systolic Blood Pressure and Diastolic Blood Pressure at 5 Weeks | Baseline, 5 weeks | The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure. | millimeters of mercury (mmHg) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Vital Signs: Pulse Rate at 5 Weeks | Baseline, 5 weeks | The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure. | beats per minute (bpm) | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Electrocardiogram Change in Heart Rate Using Bazett's (QTcB) and Fridericia's (QTcF) Formulas | Baseline through 5 weeks | The analysis population was a modified intent-to-treat (ITT) population defined as participants who received either study drug with both baseline and at least 1 postbaseline measure. | participants | NUMBER |
| SECONDARY | Percentage of Participants With Reported Hypoglycemic Events | Baseline through 5 weeks | The safety analysis population included all 273 participants randomized to study drug. | percentage of 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.
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GET https://conductscience.org/api/trials/v1/NCT00785577/outcomes