Trial · NCT02382276
A Long-term Extension Study for the Phase 3 Study of Nalmefene (339-14-001) in Patients With Alcohol Dependence
NCT02382276, Phase 3, Completed, Otsuka Pharmaceutical Co., Ltd.; results first posted 2020-07-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Long-term Extension Study for the Phase 3 Study of Nalmefene (339-14-001) in Patients With Alcohol Dependence. Trials, record NCT02382276. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02382276
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Long-term Extension Study for the Phase 3 Study of Nalmefene (339-14-001) in Patients With Alcohol Dependence
- NCT number
- NCT02382276
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 405 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Conditions
- Alcohol Dependence
- Interventions
- Nalmefene hydrochloride
- First posted
- 2015-03-06
- Last updated
- 2020-07-20
- Results first posted
- 2020-07-20
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events | 24-week treatment period | |
| Secondary | Change in the Number of Heavy Drinking Days (HDDs) From Baseline | Week 24 | |
| Secondary | Change in Total Alcohol Consumption (TAC) From Baseline | Week 24 |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events | 24-week treatment period | Safety analysis set, which included all patients who received at least one dose of study medication during the 24-week treatment period in the extension study. | Number of participants | NUMBER |
| SECONDARY | Change in the Number of Heavy Drinking Days (HDDs) From Baseline | Week 24 | Full analysis set, which included all patients from the SS who had data available for HDDs at baseline in the lead-in study and at one or more time-points in the extension study. | days/month | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Total Alcohol Consumption (TAC) From Baseline | Week 24 | Full analysis set, which included all patients from the SS who had data available for HDDs at baseline in the lead-in study and at one or more time-points in the extension study. | g/day | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events | Nalmefene 20 mg in the lead-in Study | 96 | Number of participants | ||
| Number of Participants With Adverse Events | Nalmefene 10 mg in the lead-in Study | 67 | Number of participants | ||
| Number of Participants With Adverse Events | Placebo in the lead-in Study | 141 | Number of participants | ||
| Change in the Number of Heavy Drinking Days (HDDs) From Baseline | Nalmefene 20 mg in the lead-in Study | -15.09 | Standard Error 0.77 | days/month | |
| Change in the Number of Heavy Drinking Days (HDDs) From Baseline | Nalmefene 10 mg in the lead-in Study | -17.15 | Standard Error 0.94 | days/month | |
| Change in the Number of Heavy Drinking Days (HDDs) From Baseline | Placebo in the lead-in Study | -16.35 | Standard Error 0.70 | days/month | |
| Change in Total Alcohol Consumption (TAC) From Baseline | Nalmefene 20 mg in the lead-in Study | -53.20 | Standard Error 2.29 | g/day | |
| Change in Total Alcohol Consumption (TAC) From Baseline | Nalmefene 10 mg in the lead-in Study | -57.93 | Standard Error 2.77 | g/day | |
| Change in Total Alcohol Consumption (TAC) From Baseline | Placebo in the lead-in Study | -55.77 | Standard Error 2.06 | g/day |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nalmefene 20 mg in the lead-in Study | 137 | |
| Overall Study | STARTED | Nalmefene 10 mg in the lead-in Study | 94 | |
| Overall Study | STARTED | Placebo in the lead-in Study | 172 | |
| Overall Study | COMPLETED | Nalmefene 20 mg in the lead-in Study | 126 | |
| Overall Study | COMPLETED | Nalmefene 10 mg in the lead-in Study | 84 | |
| Overall Study | COMPLETED | Placebo in the lead-in Study | 133 | |
| Overall Study | NOT COMPLETED | Nalmefene 20 mg in the lead-in Study | 11 | |
| Overall Study | NOT COMPLETED | Nalmefene 10 mg in the lead-in Study | 10 | |
| Overall Study | NOT COMPLETED | Placebo in the lead-in Study | 39 |
Source ClinicalTrials.gov
Adverse events12
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 | Abdominal discomfort | Gastrointestinal disorders | Total | 23 | 403 | |
| other | Nausea | Gastrointestinal disorders | Total | 79 | 403 | |
| other | Vomiting | Gastrointestinal disorders | Total | 25 | 403 | |
| other | Malaise | General disorders | Total | 26 | 403 | |
| other | Nasopharyngitis | Infections and infestations | Total | 62 | 403 | |
| other | Dizziness | Nervous system disorders | Total | 39 | 403 | |
| other | Headache | Nervous system disorders | Total | 29 | 403 | |
| other | Somnolence | Nervous system disorders | Total | 26 | 403 | |
| other | Insomnia | Psychiatric disorders | Total | 20 | 403 | |
| serious | Gastroenteritis | Infections and infestations | Total | 1 | 403 | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Total | 0 | 403 |
| Total, other adverse events | Total | 209 | 403 |
| Total, serious adverse events | Total | 3 | 403 |
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/NCT02382276
GET https://conductscience.org/api/trials/v1/NCT02382276/registered