Efficacy and Safety of Surinabant Treatment as an Aid to Smoking Cessation (SURSMOKE)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00432575
• Date of registration: 07/02/2007
• Prospective Registration: No
• Primary sponsor: Sanofi
• Public title: Efficacy and Safety of Surinabant Treatment as an Aid to Smoking Cessation (SURSMOKE)
• Scientific title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Fixed-Dose, 8-Week Treatment, Multi-Center Trial Evaluating the Efficacy and the Safety of 3 Oral Doses of Surinabant as an Aid to Smoking Cessation in Cigarette Smokers
• Date of first enrolment: January 2007
• Target sample size: 810
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00432575
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Belgium, France, Germany, Italy, Norway, Spain, Sweden, Switzerland

Contacts

• Name: Claire VILAIN, M.D.
• Affiliation: Sanofi

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients over legal age smoking at least 10 cigarettes/day as a mean within the 6
months preceding the screening visit.

Exclusion Criteria:

- Patients with a limited level of motivation.

- Other participant in a household enrolled in the study.

- Patients who have smoked or consumed non-tobacco cigarettes or any form of tobacco
product more than 3 days within the 3 months preceding the screening visit.

- Patients dependent to alcohol or illicit drugs.

- Patients with a diagnosis of Psychotic Disorder or currently presenting with a
Depressive Episode.

- Patients who have suffered from a myocardial infarction, unstable angina or other
major cardiovascular event within the past 6 months prior to screening.

- Pregnant or breast-feeding women or women not protected by effective contraceptive
method of birth control.

The investigator will evaluate whether there are other reasons why a patient may not
participate.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Smoking Cessation

Intervention(s)

Drug: placebo

Drug: surinabant (SR147778)

Primary Outcome(s)

Continuous abstinence from tobacco smoking (including smoking diaries, measurements of carbon monoxide and cotinine) at every visit [Time Frame: during the last four weeks of treatment]

Secondary Outcome(s)

Total score of the Questionnaire of Smoking Urges [Time Frame: 8 weeks]

Change from baseline in total body weight [Time Frame: 8 weeks]

Safety endpoints (physical examinations, vital signs, electrocardiograms, laboratory parameters, adverse events) [Time Frame: 14 weeks]

Secondary ID(s)

EUDRACT: 2006-005334-2L

DRI6938

Source(s) of Monetary Support

Please refer to primary and secondary sponsors