Trial · NCT00407511
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to End of Treatment (EOT) in Weekly Mean Pain Score on the Daily Pain Rating Scale (DPRS) | Baseline, End of Treatment | 11 point Likert scale: range 0 to 10 (no pain to worst possible pain) over past 24 hours. Baseline score = mean score of preceding 7 days (including Visit 2). Final end of treatment (EOT) pain score = mean pain score from last 7 post-Baseline days preceding Visit 8 (Week 12) or last 7 days on study drug for those who did not complete the study. Change = mean at EOT minus mean at Baseline. |
| Secondary | Change From Baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS) | Week 4, Week 8, Week 12 | 11 point Likert scale; range: 0 to 10 (no pain to worst possible pain) over past 24 hours. Baseline score = mean score of preceding 7 days (including Visit 2). Weekly pain score = mean pain score from last 7 post-Baseline days preceding observation visit or last 7 days on study drug for early termination. Change = mean at observation minus mean at Baseline. |
| Secondary | Change From Baseline (BL) in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores | Baseline, Week 8, Week 12, EOT/LOCF | Self-administered questionnaire: change from Baseline in mean pain severity index over past 24 hours; 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst pain possible). Pain severity index is the mean of item scores 2, 3, and 4 (pain right now, worst pain, and average pain level). Change = mean score at observation minus mean score at Baseline. |
| Secondary | Change From Baseline in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores | Baseline, Week 8, Week 12, End of Treatment/Last Observation Carried Forward (EOT/LOCF) | Self-administered questionnaire: change from Baseline in mean pain interference with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. 11-point scale from 0 (does not interfere) to 10 (completely interferes). Change = observation mean minus Baseline mean. |
| Secondary | Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication | Baseline, Week 8, Week 12, EOT/LOCF | Impact of current pain medication response scale: 0 (worst possible response) to 100 (best possible response). Score=\[(5-mean of non-missing items)\*100\]/4. |
| Secondary | Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication | Baseline, Week 8, Week 12, EOT/LOCF | Satisfaction with current pain medication response scale: 0 (worst possible response) to 100 (best possible response). Score=\[(5-mean of non-missing items)\*100\]/4. |
| Secondary | Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) | Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, EOT/LOCF | 100 mm line (Visual Analog Scale) marked by subject; Intensity of pain range (over past week): 0 = no pain to 100 = worst possible pain. Change = observation mean minus Baseline mean. |
| Secondary | Change From Baseline in Global Anxiety Visual Analogue Scale (GA-VAS) | Baseline, Week 8, Week 12, EOT/LOCF | 100-mm line (Visual Analog Scale) marked by the subject to measure their degree of anxiety over past 24 hours. Range: 0 = not at all anxious to 100 = extremely anxious. Change = mean score at observation minus mean score at Baseline. |
| Secondary | Change From Baseline in Mean Daily Sleep Interference Score (DSIS) | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, EOT/LOCF | Daily sleep interference measured on an 11-point Likert scale. Range: 0 (pain did not interfere with sleep) to 10 (pain completely interfered with sleep). Change = mean at observation minus mean at Baseline. Evaluations recorded in patient's daily sleep diaries. |
| Secondary | Patient Global Impression of Change (PGIC) | End of Treatment/ Last Observation Carried Forward (Week 12 or last post-baseline assessment) | 7-point participant rating scale for change observed in their overall status since beginning of study medication. Range: 1 (very much improved) to 7 (very much worse) |
| Secondary | Clinical Global Impression of Change (CGIC) | End of Treatment/ Last Observation Carried Forward (Week 12 or last post-baseline assessment) | 7-point investigator rating scale of change in participant's status since beginning study medication. Range: 1 (very much improved) to 7 (very much worse). |
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/NCT00407511/registered