Trial · NCT00397189
Efficacy and Safety of Circadin® 2 mg in the Treatment of Primary Insomnia Patients
NCT00397189, Phase 3, Completed, Neurim Pharmaceuticals Ltd.; results first posted 2011-03-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Circadin® 2 mg in the Treatment of Primary Insomnia Patients. Trials, record NCT00397189. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00397189
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Circadin® 2 mg in the Treatment of Primary Insomnia Patients
- NCT number
- NCT00397189
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 930 participants, actual
- Lead sponsor
- Neurim Pharmaceuticals Ltd.
- Conditions
- Primary Insomnia
- Interventions
- Circadin, placebo circadin
- First posted
- 2006-11-08
- Last updated
- 2018-05-01
- Results first posted
- 2011-03-28
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Change From Baseline in Subjective Sleep Latency. | Baseline and 3 weeks | Sleep latency (SL) after 3 weeks of treatment was assessed by Patient Daily Sleep Diary (National sleep foundation sleep diary). The patients reported subjectively of their SL. The Sleep Diary question 3 (SL) was summarised at baseline (end of the two-week run-in period) and after three weeks double-blind treatment (actual and change from baseline) for each treatment group using descriptive statistics. At each visit, the mean of the seven days prior to the visit were used. For each treatment group, the mean score at visit 3 was compared, adjusting for the visit 2 score. An ANCOVA model was used. Lower score indicates reduction in sleep latency and thus considered improvement |
| Secondary | The Change From Baseline in Subjective Sleep Maintenance. | 3 weeks | Sleep maintenance as measured by number of awakening (NOA) after 3 weeks of treatment was assessed by Patient Daily Sleep Diary (National sleep foundation sleep diary). The patients reported subjectively of their NOA. The Sleep Diary question 4 (NOA) was summarized at baseline (end of the two-week run-in period) and after three weeks double-blind treatment (actual and change from baseline) for each treatment group using descriptive statistics. At each visit, the mean of the seven days prior to the visit were used. For each treatment group, the mean score at visit 3 was compared, adjusting for the visit 2 score. An ANCOVA model was used. Lower score indicates less awakenings and thus considered improvement. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Change From Baseline in Subjective Sleep Latency. | Baseline and 3 weeks | Pre-planned analysis on ITT population age 65-80 | minutes | MEAN |
| SECONDARY | The Change From Baseline in Subjective Sleep Maintenance. | 3 weeks | Awakenings | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Change From Baseline in Subjective Sleep Latency. | Circadin | -19.1 | Standard Deviation 47.3 | minutes | |
| The Change From Baseline in Subjective Sleep Latency. | Placebo | -1.7 | Standard Deviation 47.8 | minutes | |
| The Change From Baseline in Subjective Sleep Maintenance. | Circadin | -0.24 | 95% Confidence Interval -0.33 to 0 | Awakenings | |
| The Change From Baseline in Subjective Sleep Maintenance. | Placebo | -0.09 | 95% Confidence Interval -0.33 to 0 | Awakenings |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| 3 Weeks Period | STARTED | Circadin | 394 | |
| 3 Weeks Period | STARTED | Placebo | 395 | |
| 3 Weeks Period | COMPLETED | Circadin | 373 | |
| 3 Weeks Period | COMPLETED | Placebo | 373 | |
| 3 Weeks Period | NOT COMPLETED | Circadin | 21 | |
| 3 Weeks Period | NOT COMPLETED | Placebo | 22 | |
| Extension Period | STARTED | Circadin | 534 | |
| Extension Period | STARTED | Placebo | 177 | |
| Extension Period | COMPLETED | Circadin | 421 | |
| Extension Period | COMPLETED | Placebo | 134 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events14
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 | nasopharyngitis | Infections and infestations | Circadin | 13 | 394 | |
| other | nasopharyngitis | Infections and infestations | Placebo | 16 | 395 | |
| other | upper respiratory tract infection | Infections and infestations | Circadin | 8 | 394 | |
| other | upper respiratory tract infection | Infections and infestations | Placebo | 8 | 395 | |
| other | headache | Nervous system disorders | Circadin | 11 | 394 | |
| other | headache | Nervous system disorders | Placebo | 18 | 395 | |
| serious | cellulitis | Infections and infestations | Circadin | 1 | 394 | 1 |
| serious | cellulitis | Infections and infestations | Placebo | 0 | 395 | 0 |
| serious | chest pain | General disorders | Circadin | 0 | 394 | 0 |
| serious | chest pain | General disorders | Placebo | 1 | 395 | 1 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Circadin | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Circadin | 32 | 394 |
| Total, other adverse events | Placebo | 42 | 395 |
| Total, serious adverse events | Circadin | 1 | 394 |
| Total, serious adverse events | Placebo | 3 | 395 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|
| Circadin vs Placebo: 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/NCT00397189
GET https://conductscience.org/api/trials/v1/NCT00397189/registered