SCH 486757 vs Codeine and Placebo in Subjects with Persistent Postviral Cough

Phase 1

• Conditions: Postviral cough

• Registration Number: EUCTR2004-004113-42-GB
• Lead Sponsor: Schering Plough Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-03-16
• Study Completion: 2007-04-02
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 180

Inclusion Criteria

Sufficiently symptomatic- cough severity score of at least moderate at Visit 2 (Screening).

Must have had signs and symptoms indicative of a viral upper respiratory infection with an onset of at least 14 days, but not more than 90 days prior to the Pre-Screening Visit (Visit 1)

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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Pregnancy/Lactation

Use of concurrent prohibited medications unless they observe the washout period prior to the Screening and Baseline Visits (Visits 2 and 3). (including opioid- and non-opioid-containing cough suppressants, proton pump inhibitors, H2 receptor antagonists and potent CYP3A inhibitors, such as ritonavir, ketoconazole, and clarithromycin). Subjects receiving ACE inhibitors or MAOIs will be excluded from the study.

Asthma or chronic obstructive pulmonary disease that requires chronic use of inhaled or systemic corticosteroids current or history of frequent clinically significant sinusitis or chronic purulent postnasal drip. history of allergies to more than two classes of medications or with an allergy to Lycra®.

Current smokers, ex-smokers who stopped smoking in the previous 6 months, or subjects with a cumulative smoking history >10 pack-years will
be excluded.

Subjects with current gastroesophageal reflux disease.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Assess effectiveness of SCH 486757 (100 mg BID) in the reduction of cough severity score compared with placebo.;<br> Secondary Objective: Evaluate the number of coughs from LifeShirt values.<br><br> Evaluate safety profile of SCH 486757 using subject reported adverse events, ECGs, routine lab tests, vital signs evaluations, and the Stanford Sleepiness Scale.<br><br> Estimate the magnitude of exposure to SCH 486757 following 5 days of dosing of SCH 486757 100 mg BID.<br><br> ;Primary end point(s): Reduction from baseline values in the cough severity score as measured twice daily in the subject diary averaged over the 5 days of the study.