Trial · NCT01124617
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 12 | Baseline and Week 12 | Participants were asked to assess the average pain intensity on an 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number on the scale applicable to their pain. Baseline pain score is defined as the average pain intensity score over the last 3 days prior to the randomization. Change from Baseline in NRS score is the mean NRS score at Week 12 minus mean NRS score at Baseline. |
| Secondary | Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11 | Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11 | Participants were asked to assess the average pain intensity on an 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number on the scale applicable to their pain. Baseline pain score is defined as the average pain intensity score over the last 3 days prior to the randomization. Change from Baseline in NRS score is the mean NRS score at corresponding week minus mean NRS score at Baseline. |
| Secondary | Percentage of Participants With Treatment Response Based on Numerical Rating Scale (NRS) | Week 12 | Percentage of participants with treatment response in mean NRS score by greater than equal to 30 or 50 percent (%) in the last week from baseline were considered as responders. Participants were asked to assess the average pain intensity on an 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number applicable to their pain on the scale. |
| Secondary | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 8 and Week 12 | The PGIC is a 7-point scale that requires the participants to assess how much their illness has improved or worsened relative to a Baseline state at the beginning of the intervention. The response options are 1 = very much improved, 2 = much improved, 3 = minimally improve, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. |
| Secondary | Number of Participants With Categorical Scores on Physician's Global Assessment Scale | Week 8 and Week 12 | Physician's Global Assessment Scale assesses the therapeutic efficacy (effectiveness) of the study drug for pain control on a 2-point scale of "effective" and "ineffective". |
| Secondary | Change From Baseline in Pain Interference Subscale Score Based on Brief Pain Inventory (Short Form) (BPI-sf) Scale | Baseline and Week 12 | The BPI-sf consists of 15 Items (Item 1:presence of pain; Item 2:pain location; Items 3 to 6:pain severity; Item 7:status of pain treatment; Item 8:efficacy of pain treatment; and Items 9a to 9g: interference of pain with daily life). Pain interference sub-scale score ranges from 0 (do not interfere) to 10 (completely interferes). Higher scores indicates worsening. Total score is defined as the mean scores from Items 3, 4, 5, 6 and 9 recorded on an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine. Lower score indicates an improvement in pain. |
| Secondary | Change From Baseline in Pain Subscale Score Based on Brief Pain Inventory (Short Form) (BPI-sf) Scale | Baseline and Week 12 | The BPI-sf consists of 15 Items (Item 1:presence of pain; Item 2:pain location; Items 3 to 6:pain severity; Item 7:status of pain treatment; Item 8:efficacy of pain treatment; and Items 9a to 9g: interference of pain with daily life). Pain Sub-scale score ranges from 0 (absent \[no pain\]) to 10 (extreme \[pain as bad as you can image\]). Higher scores indicates worsening. Total score is defined as the mean scores from Items 3, 4, 5, 6 and 9 recorded on an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine. Lower score indicates an improvement in pain. |
| Secondary | Change From Baseline in Brief Pain Inventory (Short Form) (BPI-sf) Total Score at Week 12 | Baseline and Week 12 | The BPI-sf consists of 15 Items (Item 1:presence of pain; Item 2:pain location; Items 3 to 6:pain severity; Item 7:status of pain treatment; Item 8:efficacy of pain treatment; and Items 9a to 9g: interference of pain with daily life). Total score is defined as the mean scores from Items 3, 4, 5, 6 and 9 recorded on an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine. Lower score indicates an improvement in pain. |
| Secondary | Change From Baseline in Sleep Latency Based on Sleep Questionnaire at Week 12 | Baseline and Week 12 | Sleep Latency was related to "How long after bedtime or lights out did the participant fall asleep last night ". Decrease in time indicates an improvement. |
| Secondary | Change From Baseline in Time Slept Based on Sleep Questionnaire at Week 12 | Baseline and Week 12 | Time slept was related to "How long did the participant sleep last night". The mean change for the time in hours slept during the last night was reported. |
| Secondary | Number of Participants With Awakenings Based on Sleep Questionnaire | Baseline and Week 12 | Number of awakenings was related to "How many times did the participant wake up during the night". Lesser number signifies better sleep. |
| Secondary | Number of Participants With Response Based on Overall Quality of Sleep Questionnaire | Baseline and Week 12 | Participants rated the overall quality of sleep last night as excellent, good, fair and poor. |
| Secondary | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | Baseline and Week 12 | The SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state. |
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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