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dianicline

Phase 3

Smoking | Small molecule | Psychiatry |Sanofi|Last Updated: Dec 19, 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment602

FDA Designations

No designations recorded

Clinical trial landscape

dianicline · 1 trial · 1 indication

Phase 3 1
NCT00356967Efficacy and Safety of Dianicline Versus Placebo as an Aid to Smoking CessationSmoking
COMPLETED602 Analytics
PHASE3COMPLETED
Efficacy and Safety of Dianicline Versus Placebo as an Aid to Smoking Cessation
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Study Endpoints

Primary Endpoints

to assess the continuous abstinence from tobacco smoking at every visit during the last four weeks of treatment through direct inquiry of patients
exhaled carbon monoxide testing
and plasma cotinine measurements

Secondary Endpoints

questionnaire of smoking urge
Hughes and Hatsukami Minnesota Withdrawal Scale to measure nicotine withdrawal
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
dianiclineDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Outpatients over the legal age smoking at least 10 cigarettes per day for at least 2 months Exclusion Criteria: * Insufficient level of motivation * Another participant in the household * Patients with current psychotic disorder or major depressive disorder The investigator...

Countries:BelgiumDenmarkFranceNorwaySpainSweden
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Frequently asked questions about dianicline

What is dianicline used for?

Dianicline is an investigational small molecule being developed as an aid to smoking cessation. It is intended to help people stop smoking, and it has been studied in a Phase 3 clinical trial for this purpose. The drug is not approved and remains in clinical development.

Who makes dianicline?

Dianicline is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi has conducted clinical research on dianicline for smoking cessation, including a Phase 3 trial that has been completed.

What phase is dianicline in?

Dianicline is in Phase 3 of clinical development. A Phase 3 trial, NCT00356967, has been completed. This trial was a randomized, double-blind study designed to evaluate the efficacy and safety of dianicline versus placebo as an aid to smoking cessation. The drug is still investigational and not approved.

What clinical trials is dianicline in?

Dianicline has been studied in one clinical trial, NCT00356967, which is a Phase 3 study titled 'Efficacy and Safety of Dianicline Versus Placebo as an Aid to Smoking Cessation.' This trial enrolled 602 participants and was conducted in Belgium, Denmark, France, Norway, Spain, and Sweden. The trial has been completed.

Is dianicline FDA approved?

Dianicline is not FDA approved. It is an investigational drug that has been studied in clinical trials for smoking cessation, including a completed Phase 3 trial. However, approval status has not been established, and the drug remains in clinical development.