Trial · NCT01271933
Outcomes56
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 56
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Double-Blind Phase: Time to Loss of Therapeutic Response (LTR) | Randomization to Week 19 | Full analysis set (FAS) included all participants randomized to the double blind phase who received at least one dose of study medication in the double blind phase. | Days | MEDIAN |
| PRIMARY | Double-Blind Phase: Number of Participants With Loss of Therapeutic Response (LTR) Event | Randomization to Week 19 | FAS included all participants randomized to the double blind phase who received at least one dose of study medication in the double blind phase. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Single-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 1, 2, 3, 4, 5, 6 | Baseline, Weeks 1, 2, 3, 4, 5, 6 | Single-blind analysis set (SBAS) consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication. | Units on a scale | MEAN |
| SECONDARY | Double-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 | Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 | Full analysis set (FAS) consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. | Units on a scale | MEAN |
| SECONDARY | Double-Blind Phase: Change From Baseline in Mean Daily Pain Score at Double Blind Endpoint Visit | Baseline, Double blind endpoint visit (Week 19) | FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Single-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Weeks 1, 2, 3, 4, 5, 6 | Baseline, Weeks 1, 2, 3, 4, 5, 6 | SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication. | Units on a scale | MEAN |
| SECONDARY | Double-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 | Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 | FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. | Units on a scale | MEAN |
| SECONDARY | Double-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Double Blind Endpoint Visit | Baseline, Double blind endpoint visit (Week 19) | FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Single-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep and Subjective Latency to Sleep Onset at Weeks 1, 2, 3, 4, 5, 6 | Baseline, Weeks 1, 2, 3, 4, 5, 6 | SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication. | Minutes | MEAN |
| SECONDARY | Single-Blind Phase: Change From Baseline in Daily SSQ - Subjective Number of Awakenings After Sleep Onset at Weeks 1, 2, 3, 4, 5, 6 | Baseline, Weeks 1, 2, 3, 4, 5, 6 | SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication. Here, 'overall number of participants analyzed' signifies participants who awakened after sleep. | Number of times the participant awakened | MEAN |
| SECONDARY | Single-Blind Phase: Change From Baseline in Daily SSQ - Subjective Total Sleep Time at Weeks 1, 2, 3, 4, 5, 6 | Baseline, Weeks 1, 2, 3, 4, 5, 6 | SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication. | Hours | MEAN |
| SECONDARY | Single-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Weeks 1, 2, 3, 4, 5, 6 | Baseline, Weeks 1, 2, 3, 4, 5, 6 | SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication. Here, 'overall number of participants analyzed' signifies participants evaluable for this outcome measure. | Units on a scale | MEAN |
| SECONDARY | Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 | Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 | FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. | Minutes | MEAN |
| SECONDARY | Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 | Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 | FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. | Number of times the participant awakened | MEAN |
| SECONDARY | Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 | Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 | FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. | Hours | MEAN |
| SECONDARY | Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 | Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 | FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. | Units on a scale | MEAN |
| SECONDARY | Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Double Blind Endpoint Visit | Baseline, Double blind endpoint visit (Week 19) | FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure. | Minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset at Double Blind Endpoint Visit | Baseline, Double blind endpoint visit (Week 19) | FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure. | Number of times the participant awakened | LEAST_SQUARES_MEAN |
| SECONDARY | Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time at Double Blind Endpoint Visit | Baseline, Double blind endpoint visit (Week 19) | FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure. | Hours | LEAST_SQUARES_MEAN |
| SECONDARY | Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Double Blind Endpoint Visit | Baseline, Double blind endpoint visit (Week 19) | FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure. | Units on a scale | LEAST_SQUARES_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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