Trial · NCT03663374
Efficacy and Safety Evaluating Study of Odelepran for the Use in Patient With Alcohol Dependence
NCT03663374, Phase 3, Completed, R-Pharm
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety Evaluating Study of Odelepran for the Use in Patient With Alcohol Dependence. Trials, record NCT03663374. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03663374
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Evaluating Study of Odelepran for the Use in Patient With Alcohol Dependence
- NCT number
- NCT03663374
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 644 participants, actual
- Lead sponsor
- R-Pharm
- Conditions
- Alcohol Dependence
- Interventions
- Odelepan, Placebo
- First posted
- 2018-09-10
- Last updated
- 2019-05-22
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from baseline in the mean daily alcohol consumption | Baseline and Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 of treatment | Calculated as total number of drinks in month divided by number of days in month. |
| Secondary | Change in the number of days of abstinence per month as compared to the baseline | Baseline and Week 24 of treatment | |
| Secondary | Change in the percentage of days of heavy drinking per month as compared to the baseline | Baseline and Week 24 of treatment | Heavy drinking to be considered as 5 or more drinks per day for men and 4 or more drinks per day for women. |
| Secondary | Time to the first day of drinking | From baseline till the first day of alcohol consumption | Full abstinence period duration. |
| Secondary | Time to the first day of heavy drinking | From baseline till the first day of heavy drinking | Heavy drinking to be considered as 5 or more drinks per day for men and 4 or more drinks per day for women. |
| Secondary | Change from baseline in alcohol consumption per drinking day | Baseline and Week Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24 of treatment | Calculated as total number of drinks in month divided by number of drinking days in month. |
| Secondary | Change in alcohol craving from the baseline (based on Obsessive-Compulsive Drinking Scale (OCDS) score) | Baseline and Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 of treatment | The OCDS is a validated scale consisted of 14 items for patient self-assessment of alcohol craving. Scoring by simple addition. Higher scores indicate greater level of craving (Anton R.F., Moak D.H., Latham P.K., 1996). |
| Secondary | Change in alcohol craving (based on completed VIsual Analogue Scale) | Baseline and Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 of treatment | VIsual Analogue Scale (VAS) ranged from 0 to 100, where 0 corresponds to "no craving at all" and 100 corresponds to "maximal craving" |
| Secondary | Change in patient's self-assessed quality of life (by the SF-36 Questionnaire) as compared to the baseline | Baseline and Week 8, 24 of treatment | The Short Form Health Survey (SF-36) is a validated 36 item self-report Quality of Life Questionnaire that measures eight multi-item dimensions of health: physical functioning, social functioning, role limitations due to physical problems, role limitations due to emotional problems, mental health, energy/vitality, pain, and general health perception. Version 2 was used. (Ware J.E., 2000) |
| Secondary | Proportion of patient with clinical improvement as assessed by Clinical Global Impression-improvement (CGI-I) scale | Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24 of treatment | CGI-I scale is a 7 point scale that requires the investigator to assess how much the patient's illness has improved or worsened relative to a baseline. Rated as: 1 - very much improved, 2 - much improved, 3 - minimally improved, 4 - no change, 5 - minimally worse, 6 - much worse, 7 - very much worse. (Guy W, 1970; 1976) |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes0
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/NCT03663374
GET https://conductscience.org/api/trials/v1/NCT03663374/registered