Trial · NCT02058992
Ramelteon Tablets 8mg Drug Use Surveillance: Survey on Insomnia Associated With Sleep-onset Difficulty
NCT02058992, Completed, Takeda; results first posted 2016-07-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ramelteon Tablets 8mg Drug Use Surveillance: Survey on Insomnia Associated With Sleep-onset Difficulty. Trials, record NCT02058992. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02058992
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ramelteon Tablets 8mg Drug Use Surveillance: Survey on Insomnia Associated With Sleep-onset Difficulty
- NCT number
- NCT02058992
- Status
- Completed
- Enrollment
- 3,339 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Insomnia
- Interventions
- Ramelteon
- First posted
- 2014-02-11
- Last updated
- 2016-07-14
- Results first posted
- 2016-07-14
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Reporting One or More Adverse Drug Reactions | Baseline up to 6 weeks | Adverse drug reactions are defined as adverse events (AE) which are in the investigator's opinion of causal relationship to the study treatment. AE are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. |
| Primary | Number of Participants Reporting One or More Serious Adverse Drug Reactions | Baseline up to 6 weeks | Serious adverse drug reactions are defined as serious adverse events (SAE) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
| Secondary | Sleep Status: Sleep Onset Latency | Baseline and Week 4 | Sleep status was determined by measuring the sleep onset latency, defined as the length of time taken from lying down for the night until sleep onset. |
| Secondary | Sleep Status: Total Sleep Time | Baseline and Week 4 | Sleep status was determined by measuring the total sleep time, defined as the amount of actual sleep time during a sleep episode. |
| Secondary | Sleep Status: Number of Awakenings | Baseline and Week 4 | Sleep status of participants was assessed and summarized by calculating the number of times participants had awaken from the time of start of the investigation. |
| Secondary | Percentage of Participants Who Responded With Improvement on the Patient Global Impression (PGI) Scale at Week 4 | Week 4 | PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. 7 items on scale include sleep onset, sleep time, sleep quality, morning awakening, morning tiredness, daytime somnolence, and daytime physical condition/function. Participants provide their response on a PGI questionnaire. The results of survey using the PGI questionnaire was scored, summarized and assessed. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as "much better" or "a little better" were reported for sleep onset,time, quality; morning awakening, tiredness and daytime sleepiness, physical condition. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Reporting One or More Adverse Drug Reactions | Baseline up to 6 weeks | Safety analysis set was defined as participants who were enrolled and completed the study. | participants | NUMBER |
| PRIMARY | Number of Participants Reporting One or More Serious Adverse Drug Reactions | Baseline up to 6 weeks | SAS was defined as participants who were enrolled and completed the study. | participants | NUMBER |
| SECONDARY | Sleep Status: Sleep Onset Latency | Baseline and Week 4 | The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available. | minutes | MEAN |
| SECONDARY | Sleep Status: Total Sleep Time | Baseline and Week 4 | The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available. | hours | MEAN |
| SECONDARY | Sleep Status: Number of Awakenings | Baseline and Week 4 | The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available. | number of awakenings | MEAN |
| SECONDARY | Percentage of Participants Who Responded With Improvement on the Patient Global Impression (PGI) Scale at Week 4 | Week 4 | The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Reporting One or More Adverse Drug Reactions | Ramelteon | 109 | participants | ||
| Number of Participants Reporting One or More Serious Adverse Drug Reactions | Ramelteon | 1 | participants | ||
| Sleep Status: Sleep Onset Latency | Ramelteon | Baseline | 89.8 | Standard Deviation 66.7 | minutes |
| Sleep Status: Sleep Onset Latency | Ramelteon | Week 4 | 47.1 | Standard Deviation 46.2 | minutes |
| Sleep Status: Total Sleep Time | Ramelteon | Baseline | 6.49 | Standard Deviation 2.00 | hours |
| Sleep Status: Total Sleep Time | Ramelteon | Week 4 | 7.31 | Standard Deviation 1.72 | hours |
| Sleep Status: Number of Awakenings | Ramelteon | Baseline | 2.1 | Standard Deviation 1.6 | number of awakenings |
| Sleep Status: Number of Awakenings | Ramelteon | Week 4 | 1.2 | Standard Deviation 1.2 | number of awakenings |
| Percentage of Participants Who Responded With Improvement on the Patient Global Impression (PGI) Scale at Week 4 | Ramelteon | Sleep onset | 69.6 | percentage of participants | |
| Percentage of Participants Who Responded With Improvement on the Patient Global Impression (PGI) Scale at Week 4 | Ramelteon | Sleep time | 63.8 | percentage of participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ramelteon | 3,339 | |
| Overall Study | COMPLETED | Ramelteon | 3,223 | |
| Overall Study | NOT COMPLETED | Ramelteon | 116 |
Source ClinicalTrials.gov
Adverse events2
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 | Somnolence | Nervous system disorders | Ramelteon | 37 | 3,223 | |
| serious | Death | General disorders | Ramelteon | 1 | 3,223 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ramelteon | ||
| Total, other adverse events | Ramelteon | 37 | 3,223 |
| Total, serious adverse events | Ramelteon | 1 | 3,223 |
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 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/NCT02058992
GET https://conductscience.org/api/trials/v1/NCT02058992/registered