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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-005318-35 | EudraCT Number | ||
| 172009 | Other Identifier | Organon Protocol Number | |
| MK-8435-003 | Other Identifier | Merck Protocol Number |
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Based on the outcome of a planned interim analysis, the study was stopped early due to futility.
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The purpose of this study is to assess the effects of SCH 900435 (Org 25935, MK-8435) on heavy drinking, safety and tolerability of SCH 900435 in participants with alcohol dependence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCH 900435 | Experimental | Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks. |
|
| Placebo | Placebo Comparator | Participants received matching placebo tablets by mouth twice daily for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCH 900435 | Drug | tablets |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Heavy Drinking Days | Percentage of heavy drinking days was defined as days with ≥5 standard drinks for men and ≥4 standard drinks for women assessed by Alcohol Timeline Follow Back (TLFB) method. The Alcohol TLFB is a drinking assessment method that obtains estimates of daily drinking by means of an interview between investigator and participant. The TLFB assesses recent drinking behavior. On the TLFB, clients retrospectively estimate their daily alcohol consumption in standard drinks over a time period prior to the interview, and thus the measure provides quantitative estimates of alcohol use. A drink is standardized to an equivalent to 25-30 cL of beer or wine coolers (5% alcohol), 12-15 cL of table wine (11-14% alcohol) and 4-6 cL of hard liquor/spirits (35-40% alcohol). Percentage was calculated based on number of heavy drinking days divided by total number of days in the given 2-week interval. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Drinks Per Drinking Day | The amount of drinking was defined as drinks per drinking day (TLFB). Drinking day is a day on which an alcoholic drink is consumed, with 'day' being defined as the period between waking up and going to sleep; the end of a day may have crossed the time point of midnight. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25257291 | Result | de Bejczy A, Nations KR, Szegedi A, Schoemaker J, Ruwe F, Soderpalm B. Efficacy and safety of the glycine transporter-1 inhibitor org 25935 for the prevention of relapse in alcohol-dependent patients: a randomized, double-blind, placebo-controlled trial. Alcohol Clin Exp Res. 2014 Sep;38(9):2427-35. doi: 10.1111/acer.12501. |
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| ID | Title | Description |
|---|---|---|
| FG000 | SCH 900435 12 mg | Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks. |
| FG001 | Placebo | Participants received matching placebo tablets by mouth twice daily for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SCH 900435 12 mg | Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks. |
| BG001 | Placebo | Participants received matching placebo tablets by mouth twice daily for 12 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percentage of Heavy Drinking Days | Percentage of heavy drinking days was defined as days with ≥5 standard drinks for men and ≥4 standard drinks for women assessed by Alcohol Timeline Follow Back (TLFB) method. The Alcohol TLFB is a drinking assessment method that obtains estimates of daily drinking by means of an interview between investigator and participant. The TLFB assesses recent drinking behavior. On the TLFB, clients retrospectively estimate their daily alcohol consumption in standard drinks over a time period prior to the interview, and thus the measure provides quantitative estimates of alcohol use. A drink is standardized to an equivalent to 25-30 cL of beer or wine coolers (5% alcohol), 12-15 cL of table wine (11-14% alcohol) and 4-6 cL of hard liquor/spirits (35-40% alcohol). Percentage was calculated based on number of heavy drinking days divided by total number of days in the given 2-week interval. | The modified Intent-to-Treat (mITT) population consisted of all participants from the All-Participants-Treated (APT) population who had at least post randomization efficacy data for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage of Days | 12 weeks |
Up to 16 weeks
The APT population consisted of all participants who received at least one dose of study drug.
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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 | SCH 900435 12 mg | Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| VOMITING | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| 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 |
|---|---|
| C520612 | N-methyl-N-(6-methoxy-1-phenyl-1,2,3,4-tetrahydronaphthalen-2-ylmethyl)aminomethylcarboxylic acid |
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| Placebo | Drug | tablets |
|
| Number of Relapses Into Heavy Drinking |
An alcohol relapse was defined as either a daily alcohol intake of 5 or more drinks for males and 4 or more drinks for females or an overall consumption of 14 drinks or more per week during at least 4 weeks (TLFB). |
| 12 weeks |
| Number of Lapses Into Any Drinking | An alcohol lapse was defined as any episode of alcohol consumption not classified as a relapse (TLFB). | 12 weeks |
| Time to First Relapse Into Drinking | Time to relapse was defined as the time to first relapse into heavy drinking (TLFB). A Hazard Ratio (SCH 900435/Placebo) of <1 means that SCH 900435 has a lower risk of relapsing as compared to Placebo. | 12 weeks |
| Percentage of Abstinent Days | Percentage of abstinent days is the percentage of study days in which participants remained abstinent during the treatment period. | 12 weeks |
| Percentage of Participants With Complete Abstinence | Percentage of total abstinence is the percentage of participants who remained abstinent during the entire treatment period. | 12 weeks |
| Global Functioning: Clinical Global Impression (CGI) - Severity of Illness | The CGI scale is a standardized tool used by investigators to rate the severity of illness, taking into account the participant's clinical condition and the severity of side effects. The CGI scores could range from 1 to 7, with a lower score reflecting a better outcome. | Day 84 |
| Global Functioning: CGI - Therapeutic Effect | The CGI scale is a standardized tool used by investigators to rate the efficacy of study drug (therapeutic effect), taking into account the participant's clinical condition and the severity of side effects. The CGI scores could range from 1 to 7, with a lower score reflecting a better outcome. | Day 84 |
| Change From Baseline in Craving Visual Analog Scale (VAS) Score | Rating of craving is included to assess a potential relationship between treatment and craving severity. Participants were asked to answer the question: "Over the past week, what has your desire or craving for an alcoholic beverage been at the time of day that you usually drink?" The 100 mm line of the VAS was anchored on the left by "No desire at all" and on the right by "Extreme desire". Participants marked a spot on the line where they felt their craving severity fit best. Craving VAS scores could range from 0 to 100, with a lower VAS score reflecting a better outcome. | Baseline and Day 84 |
| Change From Baseline in Motivation VAS Score | Participants were asked to answer the question: "Over the past week, how motivated were you to stay alcohol abstinent?" The 100 mm line of the VAS was anchored on the left by "No motivation at all" and on the right by "Extremely motivated". Motivation VAS scores could range from 0 to 100, with a higher score reflecting a better outcome. | Baseline and Day 84 |
| Change From Baseline in Mood VAS Score | Participants were asked to answer the question: "Over the past week, how did you feel?" The 100 mm line of the VAS was anchored on the left by "Extremely bad" and on the right by "Extremely good". Mood VAS scores could range from 0 to 100, with a higher VAS score reflecting a better outcome. | Baseline and Day 84 |
| Number of Participants Who Experienced an Adverse Event (AE) | An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to the study drug. | Up to 16 weeks |
| Number of Participants Who Discontinued Study Drug Due to an AE | An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to the study drug. | Up to 12 weeks |
| Withdrawal by Subject |
|
| Noncompliance With Protocol |
|
| Did Not Meet Protocol Eligibility |
|
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ID | Title | Description |
|---|
| OG000 | SCH 900435 12 mg | Participants received SCH 900435 12 mg (as three SCH 900435 4 mg tablets) by mouth twice daily for 12 weeks. |
| OG001 | Placebo | Participants received matching placebo tablets by mouth twice daily for 12 weeks. |
|
|
|
| Secondary | Number of Drinks Per Drinking Day | The amount of drinking was defined as drinks per drinking day (TLFB). Drinking day is a day on which an alcoholic drink is consumed, with 'day' being defined as the period between waking up and going to sleep; the end of a day may have crossed the time point of midnight. | The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | Drinks | 12 weeks |
|
|
|
|
| Secondary | Number of Relapses Into Heavy Drinking | An alcohol relapse was defined as either a daily alcohol intake of 5 or more drinks for males and 4 or more drinks for females or an overall consumption of 14 drinks or more per week during at least 4 weeks (TLFB). | The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure. | Posted | Mean | Standard Deviation | Relapses | 12 weeks |
|
|
|
|
| Secondary | Number of Lapses Into Any Drinking | An alcohol lapse was defined as any episode of alcohol consumption not classified as a relapse (TLFB). | The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure. | Posted | Mean | Standard Deviation | Lapses | 12 weeks |
|
|
|
|
| Secondary | Time to First Relapse Into Drinking | Time to relapse was defined as the time to first relapse into heavy drinking (TLFB). A Hazard Ratio (SCH 900435/Placebo) of <1 means that SCH 900435 has a lower risk of relapsing as compared to Placebo. | The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure. | Posted | Mean | Standard Deviation | Days | 12 weeks |
|
|
|
|
| Secondary | Percentage of Abstinent Days | Percentage of abstinent days is the percentage of study days in which participants remained abstinent during the treatment period. | The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage of Days | 12 weeks |
|
|
|
|
| Secondary | Percentage of Participants With Complete Abstinence | Percentage of total abstinence is the percentage of participants who remained abstinent during the entire treatment period. | The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure. | Posted | Number | Percentage of Participants | 12 weeks |
|
|
|
|
| Secondary | Global Functioning: Clinical Global Impression (CGI) - Severity of Illness | The CGI scale is a standardized tool used by investigators to rate the severity of illness, taking into account the participant's clinical condition and the severity of side effects. The CGI scores could range from 1 to 7, with a lower score reflecting a better outcome. | The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure. | Posted | Mean | Standard Deviation | Score on a Scale | Day 84 |
|
|
|
| Secondary | Global Functioning: CGI - Therapeutic Effect | The CGI scale is a standardized tool used by investigators to rate the efficacy of study drug (therapeutic effect), taking into account the participant's clinical condition and the severity of side effects. The CGI scores could range from 1 to 7, with a lower score reflecting a better outcome. | The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure. | Posted | Mean | Standard Deviation | Score on a Scale | Day 84 |
|
|
|
| Secondary | Change From Baseline in Craving Visual Analog Scale (VAS) Score | Rating of craving is included to assess a potential relationship between treatment and craving severity. Participants were asked to answer the question: "Over the past week, what has your desire or craving for an alcoholic beverage been at the time of day that you usually drink?" The 100 mm line of the VAS was anchored on the left by "No desire at all" and on the right by "Extreme desire". Participants marked a spot on the line where they felt their craving severity fit best. Craving VAS scores could range from 0 to 100, with a lower VAS score reflecting a better outcome. | The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a Scale | Baseline and Day 84 |
|
|
|
|
| Secondary | Change From Baseline in Motivation VAS Score | Participants were asked to answer the question: "Over the past week, how motivated were you to stay alcohol abstinent?" The 100 mm line of the VAS was anchored on the left by "No motivation at all" and on the right by "Extremely motivated". Motivation VAS scores could range from 0 to 100, with a higher score reflecting a better outcome. | The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a Scale | Baseline and Day 84 |
|
|
|
|
| Secondary | Change From Baseline in Mood VAS Score | Participants were asked to answer the question: "Over the past week, how did you feel?" The 100 mm line of the VAS was anchored on the left by "Extremely bad" and on the right by "Extremely good". Mood VAS scores could range from 0 to 100, with a higher VAS score reflecting a better outcome. | The mITT population consisted of all participants from the APT population who had at least post randomization efficacy data for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a Scale | Baseline and Day 84 |
|
|
|
|
| Secondary | Number of Participants Who Experienced an Adverse Event (AE) | An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to the study drug. | The All-Participants-Treated (APT) population consisted of all participants who received at least one dose of study drug. | Posted | Number | Participants | Up to 16 weeks |
|
|
|
| Secondary | Number of Participants Who Discontinued Study Drug Due to an AE | An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to the study drug. | The APT population consisted of all participants who received at least one dose of study drug. | Posted | Number | Participants | Up to 12 weeks |
|
|
|
| 10 |
| 75 |
| 53 |
| 75 |
| EG001 | Placebo | Participants received matching placebo tablets by mouth twice daily for 12 weeks. | 11 | 66 | 43 | 66 |
| HEPATITIS CHOLESTATIC | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
|
| ABSCESS SWEAT GLAND | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| DIVERTICULITIS | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| LOCALISED INFECTION | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| PNEUMONIA PRIMARY ATYPICAL | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| ALCOHOL POISONING | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| CONCUSSION | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| BLOOD PRESSURE ABNORMAL | Investigations | MedDRA 14.0 | Systematic Assessment |
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| CONVULSION | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| GRAND MAL CONVULSION | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| SYNCOPE | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| ALCOHOLISM | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| DRUG WITHDRAWAL MAINTENANCE THERAPY | Surgical and medical procedures | MedDRA 14.0 | Systematic Assessment |
|
| HYPERTENSIVE CRISIS | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| PHOTOPHOBIA | Eye disorders | MedDRA 14.0 | Systematic Assessment |
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| PHOTOPSIA | Eye disorders | MedDRA 14.0 | Systematic Assessment |
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| VISION BLURRED | Eye disorders | MedDRA 14.0 | Systematic Assessment |
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| VISUAL IMPAIRMENT | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| DRY MOUTH | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA 14.0 | Systematic Assessment |
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| INFLUENZA | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| NASOPHARYNGITIS | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| BALANCE DISORDER | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| TUNNEL VISION | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| VISUAL FIELD DEFECT | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
In case the proposed publication contains reference to an invention owned by Organon or to which Organon otherwise has rights, Organon may request a reasonable suspension of the publication in order to be able to file a patent application protecting such invention.