Efficacy and Safety of BP1.4979 in Smoking Cessation

Phase 2

Completed

• Conditions: Tobacco Addiction
• Interventions: Drug: Placebo; Drug: BP1.4979

• Registration Number: NCT01785147
• Lead Sponsor: Bioprojet

Brief Summary

Clinical study which aim is to assess in heavy smokers willing to quit smoking the efficacy and the safety profile of BP1.4979 for smoking cessation on the total abstinence measured by subject diary and confirmed by exhaled CO (abstinent \< 10 ppm).

Detailed Description

BP1.4979 is a novel compound with promising efficacy on smoker which have been assessed on phase I studies.

This is a multicenter,randomized, double blind, placebo controlled, phase IIb trial with parallel group to assess safety and efficacy of BP1.4979 in smoker.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-05
• Study First Submitted QC: 2013-02-06
• Study First Posted: 2013-02-07
• Primary Completion: 2014-07
• Study Completion: 2014-10
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-20
• Last Update Posted: 2015-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 219

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo during 3 months
BP1.4979 3mg	BP1.4979	BP1.4979 3mg during 3 months
BP1.4979 15mg	BP1.4979	BP1.4979 15mg during 3 months
BP1.4979 10mg	BP1.4979	BP1.4979 10mg during 3 months

Primary Outcome Measures

Name	Time	Method
4-week prolonged abstinence from smoking cigarettes	4 weeks	The primary measure of efficacy will be 4-week prolonged abstinence from smoking cigarettes at the end of 12-week double-blind treatment phase (i.e. from V3 to V4).; The continuous abstinence measured by subject diary and verified by exhaled CO (abstinent \< 10 ppm) will define response to the treatment.

Secondary Outcome Measures

Name	Time	Method
7-day tobacco Point Prevalence Abstinence (PPA)	7 days	7-day tobacco Point Prevalence Abstinence (PPA) will be assessed at each visit by analysis of cigarettes consumption using self-report diaries and measurement of exhaled CO
Vital signs measures	26 weeks	Vital signs (measurement of heart rate, blood pressure, and body weight) will be assessed at each study visit, thanks to physical examinations (V0 and V4), ECG and laboratory tests (blood chemistry, haematology, urinanalysis tests, prolactin dosage) at screening (V0), after 4-week treatment (V2) and at V4.
Number of adverse events	26 weeks	Assessment of safety thanks to the number and clinical evaluation of the adverse events.

Trial Locations

Locations (1)

Hôpital Paul Brousse; 🇫🇷 Villejuif, Ile de France, France