Trial · NCT01270828
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Loss of Therapeutic Response. | 13 Weeks | The full analysis set (FAS) was the primary efficacy analysis set and consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase. | Participants | NUMBER |
| SECONDARY | Participants With Secondary LTR Based on 5 Day Rolling Average Diary Results | 13 Weeks | The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase | Participants | NUMBER |
| SECONDARY | Percentage of Participants With 30% Reduction in the Mean Pain Score. | 13 Weeks | The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With 50% Reduction in the Mean Pain Score. | 13 Weeks | The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline to Endpoint in Weekly Mean Pain Score. | SB Baseline (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19 | The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in the Weekly NRS-Pain (1-Week Recall). | SB Baseline (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19 | The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in the Medical Outcomes Study-Sleep Scale (MOS-SS). | SB Baseline (BL) (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19 | The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase. N in the below table refers to number of participants analyzed: 203 in Pregabalin DB CR group and 195 in Placebo DB group, unless otherwise specified. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in the MOS-SS-Quantity of Sleep. | SB Baseline (BL) (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19 | The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase. | Hours | LEAST_SQUARES_MEAN |
| SECONDARY | The MOS-SS-Optimal Sleep. | Week 6 and Week 19 | The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Change in the Patient Global Impression of Change (PGIC) Score | Week 19 | The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase. | Percentage of participants | NUMBER |
| SECONDARY | Change in the Short Form 36 Health Survey (SF-36) | Week 19 | The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase. N in the below table refers to number of participants analyzed: 203 in Pregabalin DB CR group and 195 in Placebo DB group, unless otherwise specified. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Mean Daily Sleep Interference Scores | Week 19 | The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Hospital Anxiety and Depression Scales (HADS) | Week 19 | The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in the Brief Pain Inventory (BPI-sf) | Week 19 | The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Benefit From Treatment, Satisfaction With Treatment and Willingness to Continue Treatement (BSW) | Week 19 | The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Events | Baseline to Week 20 | The SB Analysis Set (SBAS) consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication; The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.~Both SBAS and FAS were included in this analysis. | Participants | NUMBER |
| SECONDARY | Percentage of Participants With Suicidal Behaviour/Ideation | Baseline, Weeks 6, 11, 15, 19 and 20 | The FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study drug in the DB phase. | 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/NCT01270828/outcomes