Trial Outcomes & Findings for Effectiveness of GW468816, an NMDA Glycine Site Antagonist, for Prevention of Relapse to Smoking (NCT NCT00218465)

NCT ID: NCT00218465

Last Updated: 2017-03-24

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 264 participants
• Primary outcome timeframe: 5 weeks
• Results posted on: 2017-03-24

Participant Flow

Participant milestones

Measure	816 Group Glycine Antagonist GW468816, 200 mg/day, for a 5-week trial.	Placebo Placebo group for 5 week relapse prevention trial.
Overall Study STARTED	50	48
Overall Study COMPLETED	33	30
Overall Study NOT COMPLETED	17	18

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effectiveness of GW468816, an NMDA Glycine Site Antagonist, for Prevention of Relapse to Smoking

Baseline characteristics by cohort

Measure	816 Group n=50 Participants Glycine Antagonist GW468816, 200 mg/day, for a 5-week trial.	Placebo n=48 Participants Placebo group for 5 week relapse prevention trial.	Total n=98 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	50 Participants n=5 Participants	48 Participants n=7 Participants	98 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	49.3 years STANDARD_DEVIATION 10.5 • n=5 Participants	46.5 years STANDARD_DEVIATION 10.4 • n=7 Participants	47.9 years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	50 Participants n=5 Participants	48 Participants n=7 Participants	98 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants	48 participants n=7 Participants	98 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 weeks

Outcome measures

Measure	816 Group n=50 Participants Glycine Antagonist GW468816, 200 mg/day, for a 5-week trial.	Placebo n=48 Participants Placebo group for 5 week relapse prevention trial.
Time to Relapse to Smoking in the 5-week Relapse Prevention Phase.	14.5 days Standard Deviation 14.0	12.4 days Standard Deviation 12.5

PRIMARY outcome

Timeframe: 5 weeks

Outcome measures

Measure	816 Group n=50 Participants Glycine Antagonist GW468816, 200 mg/day, for a 5-week trial.	Placebo n=48 Participants Placebo group for 5 week relapse prevention trial.
Number of Abstinent and Nonabstinent Participants at End of 5 Week Placebo-controlled Relapse Prevention Trial	50 participants	48 participants

PRIMARY outcome

Timeframe: 60 days

Outcome measures

Measure	816 Group n=50 Participants Glycine Antagonist GW468816, 200 mg/day, for a 5-week trial.	Placebo n=48 Participants Placebo group for 5 week relapse prevention trial.
Days to Relapse Within the 60 Days Following Randomization	20.8 days Standard Deviation 18.3	20.6 days Standard Deviation 20.3

Adverse Events

816 Group

Serious events: 2 serious events

Other events: 31 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Measure	816 Group n=50 participants at risk Glycine Antagonist GW468816, 200 mg/day, for a 5-week trial.	Placebo n=48 participants at risk Placebo group for 5 week relapse prevention trial.
Respiratory, thoracic and mediastinal disorders small cell adenocarcinoma	2.0% 1/50 • Number of events 1 • Five weeks.	0.00% 0/48 • Five weeks.
Skin and subcutaneous tissue disorders facial edema	2.0% 1/50 • Number of events 1 • Five weeks.	0.00% 0/48 • Five weeks.
Gastrointestinal disorders Diverticulitis	0.00% 0/50 • Five weeks.	2.1% 1/48 • Number of events 1 • Five weeks.

Other adverse events

Measure	816 Group n=50 participants at risk Glycine Antagonist GW468816, 200 mg/day, for a 5-week trial.	Placebo n=48 participants at risk Placebo group for 5 week relapse prevention trial.
Cardiac disorders Cardiovascular	6.0% 3/50 • Number of events 3 • Five weeks.	4.2% 2/48 • Number of events 2 • Five weeks.
General disorders General/Administration Site	16.0% 8/50 • Number of events 8 • Five weeks.	14.6% 7/48 • Number of events 7 • Five weeks.
Gastrointestinal disorders Gastrointestinal	28.0% 14/50 • Number of events 14 • Five weeks.	22.9% 11/48 • Number of events 11 • Five weeks.
Musculoskeletal and connective tissue disorders Musculoskeletal	12.0% 6/50 • Number of events 6 • Five weeks.	12.5% 6/48 • Number of events 6 • Five weeks.
Nervous system disorders Nervous System	24.0% 12/50 • Number of events 12 • Five weeks.	31.2% 15/48 • Number of events 15 • Five weeks.
Respiratory, thoracic and mediastinal disorders Respiratory	12.0% 6/50 • Number of events 6 • Five weeks.	27.1% 13/48 • Number of events 13 • Five weeks.
Skin and subcutaneous tissue disorders Dermatological	8.0% 4/50 • Number of events 4 • Five weeks.	4.2% 2/48 • Number of events 2 • Five weeks.

Additional Information

Sara Carlini

Center for Addiction Medicine

Phone: 617-643-1990

Email: scarlini@partners.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place