Trial · NCT00756002
Safety and Efficacy Study of Ramelteon in Subjects With Chronic Insomnia
NCT00756002, Phase 3, Completed, Takeda; results first posted 2009-11-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy Study of Ramelteon in Subjects With Chronic Insomnia. Trials, record NCT00756002. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00756002
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study of Ramelteon in Subjects With Chronic Insomnia
- NCT number
- NCT00756002
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 259 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Sleep Initiation and Maintenance Disorders
- Interventions
- Ramelteon, Placebo
- First posted
- 2008-09-19
- Last updated
- 2010-06-02
- Other registries' IDs
- eudract:2007-000403-15
- Results first posted
- 2009-11-05
Source ClinicalTrials.gov
Registered outcomes45
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Latency to Persistent Sleep Via Polysomnography (Nights 1-2). | Nights 1-2 | Elapsed time from the beginning of the Polysomnography recording to the onset of the first 10 minutes of continuous sleep was measured over 2 nights and the average time to sleep was calculated. |
| Secondary | Mean Latency to Persistent Sleep Via Polysomnography (Nights 15-16). | Nights 15-16 | Elapsed time from the beginning of the Polysomnography recording to the onset of the first 10 minutes of continuous sleep was measured. |
| Secondary | Mean Latency to Persistent Sleep Via Polysomnography (Nights 29-30). | Nights 29-30 | Elapsed time from the beginning of the Polysomnography recording to the onset of the first 10 minutes of continuous sleep was measured. |
| Secondary | Subjective Sleep Latency, Per Post-sleep Questionnaire (Nights 1-2). | Nights 1-2 | Subjective sleep latency was collected by subjects answering a post-sleep questionnaire via an interactive voice response system (IVRS) following an overnight Polysomnography in the sleep lab. |
| Secondary | Subjective Sleep Latency, Per Post-sleep Questionnaire (Nights 15-16). | Nights 15-16 | Subjective sleep latency was collected by subjects answering a post-sleep questionnaire (via IVRS) following an overnight Polysomnography in the sleep lab. |
| Secondary | Subjective Sleep Latency, Per Post-sleep Questionnaire (Nights 29-30). | Nights 29-30 | Subjective sleep latency was collected by subjects answering a post-sleep questionnaire (via IVRS) following an overnight Polysomnography in the sleep lab. |
| Secondary | Subjective Sleep Latency, Per Post-sleep Questionnaire (Week 2). | Week 2 | Subjects answered a post-sleep questionnaire via IVRS. The Subjective Sleep Latency weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting. |
| Secondary | Subjective Sleep Latency, Per Post-sleep Questionnaire (Week 4). | Week 4 | Subjects answered a post-sleep questionnaire via IVRS. The Subjective Sleep Latency weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting. |
| Secondary | Subjective Sleep Latency, Per Post-sleep Questionnaire (Week 5). | Week 5 | Subjects answered a post-sleep questionnaire via IVRS. The Subjective Sleep Latency weekly average was the mean of the daily Post-Sleep Questionnaire for the 7 nights prior to the corresponding Visit and predominantly contained data from the natural "home" setting. |
| Secondary | Total Sleep Time, Per Polysomnography (Nights 1-2). | Nights 1-2 | All of the minutes of Stages 1, 2, 3/4 Non Rapid Eye-Movement (NREM) and Rapid-Eye-Movement (REM) sleep, as measured by Polysomnography, are summed to determine the Total Sleep Time. |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 registered outcomesOutcomes45
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Latency to Persistent Sleep Via Polysomnography (Nights 1-2). | Nights 1-2 | The Full Analysis Set (FAS) population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and Last Observation Carried Forward (LOCF) data. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Latency to Persistent Sleep Via Polysomnography (Nights 15-16). | Nights 15-16 | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Latency to Persistent Sleep Via Polysomnography (Nights 29-30). | Nights 29-30 | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Subjective Sleep Latency, Per Post-sleep Questionnaire (Nights 1-2). | Nights 1-2 | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Subjective Sleep Latency, Per Post-sleep Questionnaire (Nights 15-16). | Nights 15-16 | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Subjective Sleep Latency, Per Post-sleep Questionnaire (Nights 29-30). | Nights 29-30 | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Subjective Sleep Latency, Per Post-sleep Questionnaire (Week 2). | Week 2 | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Subjective Sleep Latency, Per Post-sleep Questionnaire (Week 4). | Week 4 | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Subjective Sleep Latency, Per Post-sleep Questionnaire (Week 5). | Week 5 | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Total Sleep Time, Per Polysomnography (Nights 1-2). | Nights 1-2 | The FAS population consisted of all subjects who were randomized and received at least 1 dose of double-blind study medication. Subjects were analyzed according to the treatment they were randomized to receive. The analysis was performed using the FAS and LOCF data. | minutes | LEAST_SQUARES_MEAN |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 outcomesResults by group90
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Latency to Persistent Sleep Via Polysomnography (Nights 1-2). | Placebo QD | 67.0 | Standard Error 2.88 | minutes | |
| Mean Latency to Persistent Sleep Via Polysomnography (Nights 1-2). | Ramelteon 4 mg QD | 41.7 | Standard Error 2.83 | minutes | |
| Mean Latency to Persistent Sleep Via Polysomnography (Nights 15-16). | Placebo QD | 65.3 | Standard Error 3.09 | minutes | |
| Mean Latency to Persistent Sleep Via Polysomnography (Nights 15-16). | Ramelteon 4 mg QD | 39.2 | Standard Error 3.04 | minutes | |
| Mean Latency to Persistent Sleep Via Polysomnography (Nights 29-30). | Placebo QD | 60.5 | Standard Error 2.95 | minutes | |
| Mean Latency to Persistent Sleep Via Polysomnography (Nights 29-30). | Ramelteon 4 mg QD | 37.2 | Standard Error 2.89 | minutes | |
| Subjective Sleep Latency, Per Post-sleep Questionnaire (Nights 1-2). | Placebo QD | 73.5 | Standard Error 2.84 | minutes | |
| Subjective Sleep Latency, Per Post-sleep Questionnaire (Nights 1-2). | Ramelteon 4 mg QD | 61.5 | Standard Error 2.80 | minutes | |
| Subjective Sleep Latency, Per Post-sleep Questionnaire (Nights 15-16). | Placebo QD | 72.3 | Standard Error 3.29 | minutes | |
| Subjective Sleep Latency, Per Post-sleep Questionnaire (Nights 15-16). | Ramelteon 4 mg QD | 55.8 | Standard Error 3.23 | minutes |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Placebo Run-in | STARTED | Placebo QD | 488 | |
| Placebo Run-in | STARTED | Ramelteon 4 mg QD | 0 | |
| Placebo Run-in | COMPLETED | Placebo QD | 259 | |
| Placebo Run-in | COMPLETED | Ramelteon 4 mg QD | 0 | |
| Placebo Run-in | NOT COMPLETED | Placebo QD | 229 | |
| Placebo Run-in | NOT COMPLETED | Ramelteon 4 mg QD | 0 | |
| Double-Blind Treatment Period | STARTED | Placebo QD | 129 | |
| Double-Blind Treatment Period | STARTED | Ramelteon 4 mg QD | 130 | |
| Double-Blind Treatment Period | COMPLETED | Placebo QD | 114 | |
| Double-Blind Treatment Period | COMPLETED | Ramelteon 4 mg QD | 115 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events116
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Neutropenia | Blood and lymphatic system disorders | Placebo QD | 2 | 129 | |
| other | Neutropenia | Blood and lymphatic system disorders | Ramelteon 4 mg QD | 0 | 130 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Placebo QD | 0 | 129 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Ramelteon 4 mg QD | 1 | 130 | |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo QD | 0 | 129 | |
| other | Leukopenia | Blood and lymphatic system disorders | Ramelteon 4 mg QD | 1 | 130 | |
| other | Lymphocytosis | Blood and lymphatic system disorders | Placebo QD | 1 | 129 | |
| other | Lymphocytosis | Blood and lymphatic system disorders | Ramelteon 4 mg QD | 0 | 130 | |
| other | Arrhythmia supraventricular | Cardiac disorders | Placebo QD | 1 | 129 | |
| other | Arrhythmia supraventricular | Cardiac disorders | Ramelteon 4 mg QD | 0 | 130 |
1 to 10 of 116Source ClinicalTrials.gov
See all 116 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo QD | ||
| Total, all-cause mortality | Ramelteon 4 mg QD | ||
| Total, other adverse events | Placebo QD | 34 | 129 |
| Total, other adverse events | Ramelteon 4 mg QD | 35 | 130 |
| Total, serious adverse events | Placebo QD | 0 | 129 |
| Total, serious adverse events | Ramelteon 4 mg QD | 0 | 130 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Ramelteon 4 mg QD vs Placebo QD: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00756002
GET https://conductscience.org/api/trials/v1/NCT00756002/registered?page=2