Trial · NCT00315445
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 | Pain on the Average, Mean Change From Baseline Days 21-84 (Last Observation Carried Forward [LOCF]) | On baseline day 1 and days 21, 30, 45, 60, 75, and 84, and, if applicable, at early termination. | All 134 subjects randomized and received study drug were included in the intent-to-treat (ITT) and safety analyses. ITT Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from study because the informed consent was never obtained. This subject had no efficacy data but was included the analysis of discontinuation due to lack of efficacy. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Physical Functioning Scale of the Medical Outcomes Survey (MOS) 36 Item Short-Form Health Survey (SF-36): Mean Percent ± Standard Error of the Mean (SEM) at Day 84 (LOCF) | Day 84, or, if applicable, at early termination | All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained. | Units on a scale | MEAN |
| SECONDARY | Physical Role Scale (MOS SF-36): Mean Percent ± SEM at Day 84(LOCF) | Day 84 | All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained. | Units on a scale | MEAN |
| PRIMARY | Pain Right Now, Mean Change From Baseline, Days 21-84 (LOCF) | Assessed at baseline day 1 and days 21, 30, 45, 60, 75, and 84, and, if applicable, at early termination. | All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Bodily Pain (MOS SF-36): Mean Percent at Day 84 (LOCF) | Day 84 | All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained. | Units on a scale | MEAN |
| SECONDARY | General Health (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF) | Day 84 | All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained. | Units on a scale | MEAN |
| SECONDARY | Vitality (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF) | Day 84 | All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained. | Units on a scale | MEAN |
| SECONDARY | Social Functioning (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF) | Day 84 | All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained. | Units on a scale | MEAN |
| SECONDARY | Emotional Role (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF) | Day 84 | All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained. | Units on a scale | MEAN |
| SECONDARY | Mental Health (MOS SF-36):Mean Percent ± SEM at Day 84 (LOCF) | Day 84 | All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained. | Units on a scale | MEAN |
| SECONDARY | Therapeutic Response - Investigator: Mean ± SEM (Day 84)(LOCF) | Day 84 | All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained. | Units on a scale | MEAN |
| SECONDARY | Therapeutic Response - Subject: Mean ± SEM (Day 84) (LOCF) | Day 84 | All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained. | Units on a scale | MEAN |
| SECONDARY | Subject Comparison to Prestudy Analgesic: Mean ± SEM (Day 84)(LOCF) | Day 84 | All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained. | Units on a scale | MEAN |
| SECONDARY | Subject Satisfaction: Mean ± SEM (Day 84)(LOCF) | Day 84 | All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained. | Units on a scale | MEAN |
| SECONDARY | Time to Stable Pain Management | Start of study to day 21. | All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained. | Days | MEDIAN |
| SECONDARY | The Time to Discontinuation Due to Lack of Efficacy | Time after dosing to dropout due to lack of efficacy | All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn because the informed consent was never obtained and had no efficacy data. | Days | MEDIAN |
| POST_HOC | Sensitivity Analysis: Pain on the Average Change From Baseline in the Maintenance Period (Days 21 - 84) Baseline Observation Carried Forward (BOCF) | Baseline to days 21 - 84 | All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained. | Units on a scale | LEAST_SQUARES_MEAN |
| POST_HOC | Sensitivity Analysis: Pain Right Now Change From Baseline in the Maintenance Period (Days 21-84), BOCF | Baseline to days 21-84 | All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained. | Units on a scale | LEAST_SQUARES_MEAN |
| POST_HOC | Sensitivity Analysis Pain on the Average Change From Baseline in the Maintenance Period (Days 21-84) (Hybrid BOCF/LOCF) | Baseline to days 21-84 | All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained. | Units on a scale | LEAST_SQUARES_MEAN |
| POST_HOC | Sensitivity Analysis: Pain Right Now Change From Baseline in the Maintenance Period (Days 21-84) (Hybrid BOCF/LOCF) | Baseline to days 21-84 | All 134 subjects who were randomized and received study drug were included in the intent-to-treat and safety analyses. No subjects were excluded.~Intent-to-treat Subjects With Efficacy Data (N = 133) 1 subject was withdrawn from the study because the informed consent was never obtained. | Units on a scale | LEAST_SQUARES_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/NCT00315445/outcomes