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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-152806 | Other Identifier | Japic |
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| Name | Class |
|---|---|
| H. Lundbeck A/S | INDUSTRY |
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The long-term safety and efficacy of nalmefene hydrochloride at 20 mg in patients with alcohol dependence will be evaluated in a multicenter, open-label, uncontrolled trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nalmefene hydrochloride 20 mg | Experimental | As-needed; tablets, orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nalmefene hydrochloride | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | 24-week treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Number of Heavy Drinking Days (HDDs) From Baseline | Week 24 | |
| Change in Total Alcohol Consumption (TAC) From Baseline | Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ono Hiroaki, Mr | Otsuka Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chubu | Region | Japan | ||||
| Hokkaido |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nalmefene 20 mg in the lead-in Study | Patients who completed the treatment (nalmefene hydrochloride 20 mg) in the lead-in study were eligible for the extension study. In the extension study, all patients were received nalmefene 20 mg tablets, as-needed, orally, 24-week treatment period. |
| FG001 | Nalmefene 10 mg in the lead-in Study | Patients who completed the treatment (nalmefene hydrochloride 10 mg) in the lead-in study were eligible for the extension study. In the extension study, all patients were received nalmefene 20 mg tablets, as-needed, orally, 24-week treatment period. |
| FG002 | Placebo in the lead-in Study | Patients who completed the treatment (placebo) in the lead-in study were eligible for the extension study. In the extension study, all patients were received nalmefene 20 mg tablets, as-needed, orally, 24-week treatment period. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Nalmefene 20 mg in the lead-in Study | Patients who completed the treatment (nalmefene hydrochloride 20 mg) in the lead-in study were eligible for the extension study. In the extension study, all patients were received nalmefene 20 mg tablets, as-needed, orally, 24-week treatment period. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events | 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. | Posted | Number | Number of participants | 24-week treatment period |
|
24-week treatment period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Total | Nalmefene 20 mg tablets, as-needed, orally, 24-week treatment period in the extension study |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Infections and infestations | MedDRA Ver. 19.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA Ver. 19.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Otsuka Pharmaceutical Co., LTD. | +81-3-6361-7366 | CL_OPCJ_RDA_Team@otsuka.jp |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 20, 2014 | Jul 2, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 27, 2017 | Jul 2, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C038981 | nalmefene |
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| Region |
| Japan |
| Kanto | Region | Japan |
| Kinki | Region | Japan |
| Kyusyu | Region | Japan |
| Tohoku | Region | Japan |
| Tyugoku | Region | Japan |
| Physician Decision |
|
| Nalmefene 10 mg in the lead-in Study |
Patients who completed the treatment (nalmefene hydrochloride 10 mg) in the lead-in study were eligible for the extension study. In the extension study, all patients were received nalmefene 20 mg tablets, as-needed, orally, 24-week treatment period. |
| BG002 | Placebo in the lead-in Study | Patients who completed the treatment (placebo) in the lead-in study were eligible for the extension study. In the extension study, all patients were received nalmefene 20 mg tablets, as-needed, orally, 24-week treatment period. |
| BG003 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Age, Customized | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Heavy Drinking Days (HDDs) | The number of HDDs was defined as the number of days per month [days/month] with alcohol consumption of > 60 g for males and > 40 g for females. | 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. | Mean | Standard Deviation | days/month |
|
| Total Alcohol Consumption (TAC) | TAC was defined as mean alcohol consumption per day [g/day] over a 1-month period. | 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. | Mean | Standard Deviation | g/day |
|
| OG002 | Placebo in the lead-in Study | Patients who completed the treatment (placebo) in the lead-in study were eligible for the extension study. In the extension study, all patients were received nalmefene 20 mg tablets, as-needed, orally, 24-week treatment period. |
|
|
| Secondary | Change in the Number of Heavy Drinking Days (HDDs) From Baseline | 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. | Posted | Least Squares Mean | Standard Error | days/month | Week 24 |
|
|
|
| Secondary | Change in Total Alcohol Consumption (TAC) From Baseline | 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. | Posted | Least Squares Mean | Standard Error | g/day | Week 24 |
|
|
|
| 0 |
| 403 |
| 3 |
| 403 |
| 209 |
| 403 |
| Dehydration | Metabolism and nutrition disorders | MedDRA Ver. 19.0 | Non-systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 19.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Ver. 19.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Ver. 19.0 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA Ver. 19.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA Ver. 19.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA Ver. 19.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Ver. 19.0 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA Ver. 19.0 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA Ver. 19.0 | Non-systematic Assessment |
|
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| Between 18 and 65 years |
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| >=65 years |
|
| Male |
|