Trial · NCT01008553
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 | Time From the Initial Day of Application in Double-Blind Period to Withdrawal Because of Insufficient Analgesic Efficacy | Day 1 up to Day 85 (double-blind period) and Day 92 (discontinuation of the study) | Time from start of double-blind (researchers and participants were unaware of the treatment) period to withdrawal because of insufficient analgesic efficacy based on any of the pre-defined discontinuation criteria was noted. |
| Secondary | Pain Visual Analog Scale (VAS) Score - Titration Period | Day 12-14 (Screening period) and Day 27-29 (Titration period) | The intensity of average pain (degree of pain) felt by the participants in daily living throughout the day on a "100-millimeter (mm) VAS scale" by drawing a slash. The left margin (0 mm) was considered "No pain at all", and the right margin (100 mm) was considered "Severer pain than this is inconceivable". The length (mm) from the left margin to the slash is measured. Mean VAS score during 3 days before the end of Screening period and during 3 days before the end of titration period was reported. |
| Secondary | Pain Visual Analog Scale (VAS) Score - Double-Blind Period | Day 27-29 (Titration period) and Day 83-85 (double-blind period) | The intensity of average pain (degree of pain) felt by the participants in daily living throughout the day on a "100-millimeter (mm) VAS scale" by drawing a slash. The left margin (0 mm) was considered "No pain at all", and the right margin (100 mm) was considered "Severer pain than this is inconceivable". The length (mm) from the left margin to the slash is measured. Mean VAS score during 3 days before the end of titration period and during 3 days before the end of double-blind period was reported. |
| Secondary | Number of Participants Evaluated as Per Participant's Overall Assessment - Titration Period | Day 1 and 29 or final evaluation (Titration period) | The participant assessed his/her satisfaction with the therapeutic efficacy by the following 5 grades: "Extremely satisfied", "Satisfied", "Neither satisfied nor dissatisfied", "Dissatisfied" and "Dissatisfied very much". The results were reported as Category 1 = At least "Neither satisfied nor dissatisfied", which included participants with general evaluation of "Extremely satisfied" to "Neither satisfied nor dissatisfied", and Category 2 = At least "Satisfied", which included participants with general evaluation of "Extremely satisfied" to "Satisfied". |
| Secondary | Number of Participants Evaluated as Per Participant's Overall Assessment - Double-Blind Period | Day 1 and 85 or final evaluation (double-blind period) | The participant assessed his/her satisfaction with the therapeutic efficacy by the following 5 grades: "Extremely satisfied", "Satisfied", "Neither satisfied nor dissatisfied", "Dissatisfied" and "Dissatisfied very much". The results were reported as Category 1 = At least "Neither satisfied nor dissatisfied", which included participants with general evaluation of "Extremely satisfied" to "Neither satisfied nor dissatisfied", and Category 2 = At least "Satisfied", which included participants with general evaluation of "Extremely satisfied" to "Satisfied". |
| Secondary | Number of Doses of Rescue Treatment Per Day - Titration Period | Day 1 and 29 or final evaluation (Titration period) | If a breakthrough pain occurred or the analgesic efficacy became insufficient, a fast-acting oral morphine was administered. At such instances, one-time dose of the rescue treatment was administered as per the pre-defined criteria. During hospitalization, Investigator, Sub-investigator or Study Collaborator recorded in the medical record and during the out-patient period, the participants were instructed to describe the name of rescue treatment, date and time of treatment, and one-time dose in the participant's diary. |
| Secondary | Number of Doses of Rescue Treatment Per Day - Double-Blind Period | Day 1 and 85 or final evaluation (double-blind period) | If a breakthrough pain occurred or the analgesic efficacy became insufficient, a fast-acting oral morphine was administered. At such instances, one-time dose of the rescue treatment was administered as per the pre-defined criteria. During hospitalization, Investigator, Sub-investigator or Study Collaborator recorded in the medical record and during the out-patient period, the participants were instructed to describe the name of rescue treatment, date and time of treatment, and one-time dose in the participant's diary. |
| Secondary | Brief Pain Inventory Short Form (BPI-sf) Score - Titration Period | Day 1 and 29 or final evaluation (Titration period) | The BPI-sf total score is an average of the pain interference score (mean value for the nine BPI-sf questions \[questions inquiring about the extent of interference with activities by pain, where the extent is ranked from 0 (does not interfere) to 10 (completely interferes)\]) and pain subscale score (mean value for the scores for BPI-sf questions 3, 4, 5 and 6 \[questions inquiring about the extent of pain, where the extent is ranked from 0 (no pain) to 10 (pain as bad as you can imagine)\]). Total score ranges from 0 to 10 with higher values indicating more pain. |
| Secondary | Brief Pain Inventory Short Form (BPI-sf) Score - Double-Blind Period | Day 1 and 85 or final evaluation (double-blind period) | The BPI-sf total score is an average of the pain interference score (mean value for the nine BPI-sf questions \[questions inquiring about the extent of interference with activities by pain, where the extent is ranked from 0 (does not interfere) to 10 (completely interferes)\]) and pain subscale score (mean value for the scores for BPI-sf questions 3, 4, 5 and 6 \[questions inquiring about the extent of pain, where the extent is ranked from 0 (no pain) to 10 (pain as bad as you can imagine)\]). Total score ranges from 0 to 10 with higher values indicating more pain. |
| Secondary | Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) Score - Titration Period | Day 1 and 29 or final evaluation (Titration period) | 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. |
| Secondary | Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) Score - Double-Blind Period | Day 1 and 85 or final evaluation (double-blind period) | 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. |
| Secondary | Number of Participants Evaluated as Per Physician's Overall Assessment - Titration Period | Day 29 or final evaluation (Titration period) | Physician's global assessment of therapeutic efficacy (effectiveness) of the study drug was measured on a 2-point scale where 1 = effective and 2 = not effective. |
| Secondary | Number of Participants Evaluated as Per Physician's Overall Assessment - Double-Blind Period | Day 1 and 85 or final evaluation (double-blind period) | Physician's global assessment of therapeutic efficacy (effectiveness) of the study drug was measured on a 2-point scale where 1 = effective and 2 = not effective. |
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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GET https://conductscience.org/api/trials/v1/NCT01008553/registered