A Multicentre, Double-Blind, Placebo-Controlled, Adaptive Pivotal Study of the Efficacy and Safety of Oral BC1036 in the Management of Cough

Respicopea Limited0 sites288 target enrollmentApril 3, 2012

Overview

No summary available.

Registry

who.int

Start Date

April 3, 2012

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Respicopea Limited

•1\. Male or female aged 18 to 75 years
•2\. Confirmed diagnosis of a persistent cough as per Section 4\.2 Definition of Terms
•3\. Leicester Cough Questionnaire score of \= 17 at baseline
•4\. FEV1 \= 70% of predicted normal, at screening. See protocol Appendix 4 for formula for calculating predicted values.
•5\. Willing to use effective contraception for the duration of the study. Female subjects who are neither surgically sterilized nor post menopausal (defined as no menses for one year or an FSH value \>40 mIU/L) will be required to use two methods throughout the study and for 30 days after. Besides abstinence the following contraceptive methods are acceptable: hormonal (e.g. oral, injection, transdermal patch, implant, cervical ring), barrier (e.g. condom or diaphragm with spermicidal agent) or intrauterine device. If hormonal contraceptives are used they must be used from 6 weeks before the first administration of test product. Male subjects must agree to use condoms for the duration of the study and for 30 days after.
•6\. Willing and able to give informed consent and of complying with the trial assessments and any other trial procedures.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range

•1\. Pregnant or lactating females
•2\. Major surgery within the 30 days preceding the screening visit
•3\. Any serious infections within the 30 days prior to the screening visit
•4\. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia uncontrolled diabetes, renal or hepatic disease or psychiatric illness/social situations that would limit compliance with study requirements
•5\. Known hepatitis B or C or human immunodeficiency virus (HIV) or syphilis seropositivity.
•Note: testing for hepatitis, syphilis or HIV will not be performed as part of the screening procedures.
•6\. A history of serious adverse allergic reaction to any medication
•7\. Treatment with another investigational medicinal product within the 30 days prior to enrolment
•8\. Treatment with:
•a. Systemic oral steroids within 7 days prior to randomisation at Visit 2