Trial · NCT00811941
Safety and Efficacy of Nalmefene in Patients With Alcohol Dependence
NCT00811941, Phase 3, Completed, H. Lundbeck A/S; results first posted 2013-08-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of Nalmefene in Patients With Alcohol Dependence. Trials, record NCT00811941. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00811941
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Nalmefene in Patients With Alcohol Dependence
- NCT number
- NCT00811941
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 665 participants, actual
- Lead sponsor
- H. Lundbeck A/S
- Conditions
- Alcohol Dependence
- Interventions
- Placebo, Nalmefene
- First posted
- 2008-12-19
- Last updated
- 2013-08-07
- Other registries' IDs
- eudract:2007-002315-92
- Results first posted
- 2013-08-07
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Adverse Events (AEs) | Serious Adverse Events: 52 weeks and a safety follow-up (visit/telephone call) scheduled for 4 weeks after completion of the study or after withdrawal from the study. Other Adverse Events: 52 weeks. | Overview of AEs |
| Primary | Percentage of Patients Who Withdrew Due to Intolerance to Treatment | Baseline to Week 52 | |
| Primary | Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs) | Baseline and Month 6 | Number of HDDs over a month (28 days), where one HDD was defined as a day with alcohol consumption ≥60 grams (g) for men and ≥40 g for women. |
| Primary | Change From Baseline in the Monthly Total Alcohol Consumption (TAC) | Baseline and Month 6 | TAC was defined as mean daily alcohol consumption in g/day over a month (28 days). |
| Secondary | Drinking Risk Level (RSDRL) Response | Month 6 | RSDRL response was defined as a downward shift from baseline in Drinking Risk Level (DRL); for patients at very high risk at Baseline: a shift to medium risk or below, and for patients at high or medium risk at Baseline: a shift to low risk or below. |
| Secondary | Change From Baseline in Clinical Status Using CGI-S | Baseline and Week 24 | The Clinical Global Impression - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients). |
| Secondary | Change in Clinical Status Using the CGI-I | Week 24 | The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7- point scale ranging from 1 (very much improved) to 7 (very much worse). |
| Secondary | Liver Function Test Gamma-glutamyl Transferase (GGT) | Week 24 | GGT values |
| Secondary | Liver Function Test Alanine Aminotransferase (ALAT) | Week 24 | ALAT values |
| Secondary | Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs) | Baseline and Month 13 | Number of HDDs over a month (28 days), where one HDD was defined as a day with alcohol consumption ≥60 g for men and ≥40 g for women. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With Adverse Events (AEs) | Serious Adverse Events: 52 weeks and a safety follow-up (visit/telephone call) scheduled for 4 weeks after completion of the study or after withdrawal from the study. Other Adverse Events: 52 weeks. | All-patients-treated set (APTS) - all patients in the APRS excluding those with no recorded investigational medicinal product (IMP) intake and all IMP returned | participants | NUMBER |
| PRIMARY | Percentage of Patients Who Withdrew Due to Intolerance to Treatment | Baseline to Week 52 | All-patients-treated Set (APTS) | percentage of participants | NUMBER |
| PRIMARY | Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs) | Baseline and Month 6 | Full-analysis set (FAS) - all patients in the APTS who had at least one valid post-baseline assessment in the main treatment period of both co-primary efficacy variables (HDD and TAC) and had an average alcohol consumption at medium Drinking Risk Level (DRL) or above according to WHO criteria at Baseline. | days | MEAN |
| PRIMARY | Change From Baseline in the Monthly Total Alcohol Consumption (TAC) | Baseline and Month 6 | FAS | g | MEAN |
| SECONDARY | Drinking Risk Level (RSDRL) Response | Month 6 | FAS | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Clinical Status Using CGI-S | Baseline and Week 24 | FAS | units on a scale | MEAN |
| SECONDARY | Change in Clinical Status Using the CGI-I | Week 24 | FAS | units on a scale | MEAN |
| SECONDARY | Liver Function Test Gamma-glutamyl Transferase (GGT) | Week 24 | FAS | IU/L | GEOMETRIC_MEAN |
| SECONDARY | Liver Function Test Alanine Aminotransferase (ALAT) | Week 24 | FAS | IU/L | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs) | Baseline and Month 13 | FAS | days | MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Adverse Events (AEs) | Placebo | Patients with AEs | 103 | participants | |
| Number of Patients With Adverse Events (AEs) | Nalmefene 18.06 mg | Patients with AEs | 377 | participants | |
| Number of Patients With Adverse Events (AEs) | Placebo | Patients with Serious AEs (SAEs) | 8 | participants | |
| Number of Patients With Adverse Events (AEs) | Nalmefene 18.06 mg | Patients with Serious AEs (SAEs) | 35 | participants | |
| Number of Patients With Adverse Events (AEs) | Placebo | Patients with AEs Leading to Withdrawal | 5 | participants | |
| Number of Patients With Adverse Events (AEs) | Nalmefene 18.06 mg | Patients with AEs Leading to Withdrawal | 57 | participants | |
| Percentage of Patients Who Withdrew Due to Intolerance to Treatment | Placebo | 1.2 | percentage of participants | ||
| Percentage of Patients Who Withdrew Due to Intolerance to Treatment | Nalmefene 18.06 mg | 8.6 | percentage of participants | ||
| Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs) | Placebo | -8.92 | Standard Error 0.56 | days | |
| Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs) | Nalmefene 18.06 mg | -9.80 | Standard Error 0.35 | days |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| All Randomised Patients | STARTED | Placebo | 166 | |
| All Randomised Patients | STARTED | Nalmefene 18.06 mg | 509 | |
| All Randomised Patients | COMPLETED | Placebo | 164 | |
| All Randomised Patients | COMPLETED | Nalmefene 18.06 mg | 501 | |
| All Randomised Patients | NOT COMPLETED | Placebo | 2 | |
| All Randomised Patients | NOT COMPLETED | Nalmefene 18.06 mg | 8 | |
| All Treated Patients | STARTED | Placebo | 164 | |
| All Treated Patients | STARTED | Nalmefene 18.06 mg | 501 | |
| All Treated Patients | COMPLETED | Placebo | 112 | |
| All Treated Patients | COMPLETED | Nalmefene 18.06 mg | 310 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events112
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 | Nausea | Gastrointestinal disorders | Placebo | 9 | 164 | |
| other | Nausea | Gastrointestinal disorders | Nalmefene 18.06 mg | 112 | 501 | |
| other | Vomiting | Gastrointestinal disorders | Placebo | 2 | 164 | |
| other | Vomiting | Gastrointestinal disorders | Nalmefene 18.06 mg | 57 | 501 | |
| other | Fatigue | General disorders | Placebo | 3 | 164 | |
| other | Fatigue | General disorders | Nalmefene 18.06 mg | 27 | 501 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 19 | 164 | |
| other | Nasopharyngitis | Infections and infestations | Nalmefene 18.06 mg | 54 | 501 | |
| other | Accidental overdose | Injury, poisoning and procedural complications | Placebo | 9 | 164 | |
| other | Accidental overdose | Injury, poisoning and procedural complications | Nalmefene 18.06 mg | 9 | 501 |
1 to 10 of 112Source ClinicalTrials.gov
See all 112 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Nalmefene 18.06 mg | ||
| Total, other adverse events | Placebo | 57 | 164 |
| Total, other adverse events | Nalmefene 18.06 mg | 273 | 501 |
| Total, serious adverse events | Placebo | 8 | 164 |
| Total, serious adverse events | Nalmefene 18.06 mg | 35 | 501 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25227627 | DERIVED |
Source PubMed
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 |
|---|
| Nalmefene 18.06 mg 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/NCT00811941
GET https://conductscience.org/api/trials/v1/NCT00811941/results?page=2