Trial · NCT00755508
Efficacy and Safety of Ramelteon Combined With Gabapentin in Treating Patients With Insomnia
NCT00755508, Phase 2, Completed, Takeda
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Ramelteon Combined With Gabapentin in Treating Patients With Insomnia. Trials, record NCT00755508. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00755508
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Ramelteon Combined With Gabapentin in Treating Patients With Insomnia
- NCT number
- NCT00755508
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 378 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Sleep Initiation and Maintenance Disorders
- Interventions
- Ramelteon and gabapentin, Ramelteon and gabapentin, Ramelteon, Gabapentin, Placebo
- First posted
- 2008-09-19
- Last updated
- 2012-02-28
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean objective wake time after persistent sleep onset in sleep lab. | Nights: 1 and 2. | |
| Secondary | Subjective wake time after persistent sleep onset determined by the post-sleep questionnaire. | Nights: 1, 2, 3, 4, 5, 6 and 7. | |
| Secondary | Number of awakenings after persistent sleep polysomnography. | Nights: 1 and 2 | |
| Secondary | Subjective number of awakenings as determined by post-sleep questionnaire. | Nights: 1, 2, 3, 4, 5, 6 and 7. | |
| Secondary | Latency to persistent sleep and total sleep time as determined by polysomnography. | Nights: 1 and 2 | |
| Secondary | Subjective sleep latency, subjective total sleep time and subjective sleep quality determined by post-sleep questionnaire. | Nights: 1, 2, 3, 4, 5, 6 and 7. | |
| Secondary | Daytime functioning determined by pre-sleep questionnaire. | Nights: 1, 2, 3, 4, 5, 6 and 7. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00755508
GET https://conductscience.org/api/trials/v1/NCT00755508/registered