Trial · NCT01049217
Outcomes33
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 33
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Mean Pain Score at Endpoint (up to Week 16) | Baseline, Endpoint (up to Week 16) | Intent to Treat (ITT) population: all randomized participants who took at least 1 dose of study drug. Imputation: mBOCF, baseline data was carried forward for participants who discontinued due to adverse events or had no post-baseline observations; otherwise last observation carried forward (LOCF). | units on a scale | MEAN |
| SECONDARY | Number of Participants With Categorical Scores on Patient Global Impression of Change (PGIC) | Week 16 | ITT population: all randomized participants who took at least 1 dose of study drug. N (number of participants analyzed) signifies those participants who were evaluable for this measure. | participants | NUMBER |
| SECONDARY | Number of Participants With Categorical Scores on Clinician Global Impression of Change (CGIC) | Week 16 | ITT population: all randomized participants who took at least 1 dose of study drug. N (number of participants analyzed) signifies those participants who were evaluable for this measure. | participants | NUMBER |
| SECONDARY | Change From Baseline in Numeric Rating Scale (NRS)-Sleep Interference Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16) | Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, Endpoint (up to Week 16) | ITT population: all randomized participants who took at least 1 dose of study drug. N (number of participants analyzed) signifies those participants who were evaluable for this measure. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Numeric Rating Scale (NRS)-Current Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16) | Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, Endpoint (up to Week 16) | ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score at Week 4, 8, 12, 16 and Endpoint (up to Week 16) | Baseline, Week 4, 8, 12, 16, Endpoint (up to Week 16) | ITT population: all randomized participants who took at least 1 dose of study drug. N (number of participants analyzed) signifies those participants who were evaluable for this measure. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Item Scores at Endpoint (up to Week 16) | Baseline, Endpoint (up to Week 16) | ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF. | units on a scale | MEAN |
| SECONDARY | Neuropathic Pain Symptom Inventory (NPSI): Change From Baseline in Number of Participants With Duration of Spontaneous Pain and Number of Pain Attacks at Endpoint (up to Week 16) | Baseline, Endpoint (up to Week 16) | ITT population: all randomized participants who took at least 1 dose of study drug. N (number of participants analyzed) signifies those participants who were evaluable for this measure. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF. | participants | NUMBER |
| SECONDARY | Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Subscales and Total Intensity Score at Endpoint (up to Week 16) | Baseline, Endpoint (up to Week 16) | ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF. | units on a scale | MEAN |
| SECONDARY | Total Sleep Time (TST) and Minutes of Interrupted Sleep (MIS) | Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16) | ITT population. N (number of participants analyzed) = participants evaluable for this measure. Missing data for endpoint (up to Week 16) imputed using LOCF. Data for Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16 were collected and reported in individual participant listings but not statistically summarized for analysis. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Sleep Fragmentation Index (SFI) | Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16) | ITT population. N (number of participants analyzed) = participants evaluable for this measure. Missing data for endpoint (up to Week 16) imputed using LOCF. Data for Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16 were collected and reported in individual participant listings but not statistically summarized for analysis. | percentage of immobile bouts | LEAST_SQUARES_MEAN |
| SECONDARY | Sleep Efficiency | Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16) | ITT population. N (number of participants analyzed) = participants evaluable for this measure. Missing data for endpoint (up to Week 16) imputed using LOCF. Data for Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16 were collected and reported in individual participant listings but not statistically summarized for analysis. | Percent time between sleep onset and end | LEAST_SQUARES_MEAN |
| SECONDARY | Total Activity Counts | Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16) | ITT population. N (number of participants analyzed) = participants evaluable for this measure. Missing data for endpoint (up to Week 16) imputed using LOCF. Data for Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16 were collected and reported in individual participant listings but not statistically summarized for analysis. | activity counts per day | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage Day Time Above Sedentary Level | Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16) | ITT population. N (number of participants analyzed) = participants evaluable for this measure. Missing data for endpoint (up to Week 16) imputed using LOCF. Data for Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16 were collected and reported in individual participant listings but not statistically summarized for analysis. | percentage of day time | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Endpoint (up to Week 16) | Baseline, Endpoint (up to Week 16) | ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF. | units on a scale | MEAN |
| SECONDARY | Medical Outcomes Study-Sleep Scale (MOS-SS): Number of Participants With Optimal Sleep | Baseline, Endpoint (up to Week 16) | ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF. | participants | NUMBER |
| SECONDARY | Change From Baseline in Hospital Anxiety and Depression Scales (HADS) at Endpoint (up to Week 16) | Baseline, Endpoint (up to Week 16) | ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Endpoint (up to Week 16) | Baseline, Endpoint (up to Week 16) | ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF. | units on a scale | MEAN |
| SECONDARY | Number of Participants Who Were Employed or Unemployed Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire | Baseline, Week 16, 17 | ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively. | participants | NUMBER |
| SECONDARY | Absenteeism and Presenteeism Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire | Baseline, Week 16, 17 | ITT population: all randomized participants who took at least 1 dose of study drug. N (number of participants analyzed) signifies those participants who were evaluable for this measure. n = participants evaluable for this measure at specified time points for each arm group, respectively. | hours | MEAN |
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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GET https://conductscience.org/api/trials/v1/NCT01049217/outcomes