Trial · NCT01678924
Registered outcomes50
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 50
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Average Pain Intensity Score - Cohort 1 | Baseline to Week 12 | The average pain intensity score at each week was the mean of the daily average pain intensity scores reported in the patient's eDiary during each 7-day period, starting with the day of study treatment injection. Patients used the 11-point Likert scale, with anchors at 0 = "no pain" and 10 = "pain as bad as you can imagine" Baseline was defined as the mean of the daily average pain intensity scores reported during the baseline period for the 7 days immediately prior to the treatment. |
| Primary | Change From Baseline in Average Pain Intensity Score - Cohort 2 | Baseline to Week 12 | The average pain intensity score at each week was the mean of the daily average pain intensity scores reported in the patient's eDiary during each 7-day period, starting with the day of study treatment injection. patients used the 11-point Likert scale, with anchors at 0 = "no pain" and 10 = "pain as bad as you can imagine" Baseline was defined as the mean of the daily average pain intensity scores reported during the baseline period for the 7 days immediately prior to the treatment. |
| Secondary | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 1 | Baseline to Week 1 | Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline |
| Secondary | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 2 | Baseline to Week 2 | Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline |
| Secondary | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 3 | Baseline to Week 3 | Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline |
| Secondary | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 4 | Baseline to Week 4 | Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease), and in 10% increments, up to 100% improvement, in average pain intensity score at each week compared with baseline |
| Secondary | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 5 | Baseline to Week 5 | Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline |
| Secondary | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 6 | Baseline to Week 6 | Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline |
| Secondary | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 7 | Baseline to Week 7 | Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline |
| Secondary | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 8 | Baseline to Week 8 | Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline |
| Secondary | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 9 | Baseline to Week 9 | Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline |
| Secondary | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 10 | Baseline to Week 10 | Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline |
| Secondary | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 11 | Baseline to Week 11 | Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline |
| Secondary | Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 12 | Baseline to Week 12 | Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline |
| Secondary | Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 1 | Baseline to Week 1 | Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline |
| Secondary | Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 2 | Baseline to Week 2 | Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline |
| Secondary | Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 3 | Baseline to Week 3 | Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline |
| Secondary | Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 4 | Baseline to Week 4 | Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline |
| Secondary | Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 5 | Baseline to Week 5 | Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline |
| Secondary | Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 6 | Baseline to Week 6 | Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline |
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
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