Study of the Efficacy and Safety of SCH 486757 in Subjects With Chronic Cough (Study P04887AM3)(COMPLETED) - Full Text View

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00506987

Purpose

This is a randomized, double-blind, placebo-controlled, crossover, single center study of SCH 486757 in subjects with chronic cough. Subjects will be randomized to receive SCH 486757 or placebo for 14 days. After a 2-week washout period, subjects will be crossed over to the other treatment. The primary objective is to evaluate the effectiveness of SCH 486757 in reducing cough reflex sensitivity as determined by a challenge with capsaicin, an agent that induces cough.

Condition	Intervention	Phase
Cough	Drug: SCH 486757 Drug: Placebo Dose 1	Phase II

MedlinePlus related topics: Cough

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Study of the Efficacy and Safety of SCH 486757 in Subjects With Chronic Idiopathic Cough

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Change from baseline in cough reflex sensitivity as assessed by log10 C5 resulting from a capsaicin challenge. A capsaicin challenge will be performed on the first day (before dosing) and on the last day of each 2 week treatment period. [ Time Frame: After 2 weeks of treatment. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in hourly cough rate over 24 hours (using an automated cough counter). Baseline will be measured as the total no. of coughs on Day 1 of each treatment period and compared with the same value on the last day of each treatment period. [ Time Frame: After 2 weeks of treatment. ] [ Designated as safety issue: No ]

Enrollment:	31
Study Start Date:	January 2007
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
SCH 486757: Experimental	Drug: SCH 486757 SCH 486757 2 x 50-mg capsule twice daily orally for 2 weeks followed by a 2-week washout period and 2 weeks of crossover treatment
Placebo: Placebo Comparator	Drug: Placebo Dose 1 Matching placebo capsules twice daily orally for 2 weeks followed by a 2 week washout period and 2 weeks of crossover treatment

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female subjects, 18 to <65 years old, with a history of a dry cough for >6 months.
By history, evaluation of gastroesophageal reflux disease was done and ruled out by a minimum of an 8-week trial of antacid therapy (with a proton-pump inhibitor [PPI] given twice daily) with no clinical response in cough.
By history, if there are clinical signs and symptoms of postnasal drip, these signs and symptoms will have been treated with a combination of an antihistamine and decongestant for a minimum of 8 weeks with no clinical response in cough.
By history, if there are clinical signs and symptoms of asthma, these signs and symptoms will have been treated with a combination of an inhaled steroid and a short-acting beta-agonist for a minimum of 8 weeks with no clinical response in cough.

Exclusion Criteria:

Subjects with current evidence of clinically significant pulmonary (especially conditions that involve coughing), hematopoietic, cardiovascular, hepatic, renal, neurologic, psychiatric, autoimmune, or other disease that precludes the subject's participation in the study. In particular, diabetics, uncontrolled hypertensives, and subjects with clinically significant cardiomyopathy, prostatic hypertrophy, glaucoma, seizure disorders, and psychiatric disorders are to be excluded from participation in this study.
Subjects with asthma or chronic obstructive pulmonary disease who require chronic use of inhaled or systemic corticosteroids.
Subjects receiving concurrent prohibited medications unless they observe the washout period prior to the baseline visit. These medications would include opioid- and non-opioid-containing cough suppressants and potent CYP3A inhibitors, such as ritonavir, ketoconazole, and clarithromycin. Subjects receiving ACE inhibitors or MAOIs will be excluded from the study.
Subjects with a history of allergies to more than two classes of medications.
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. (Pack-years is a way to measure the amount a person has smoked over a long period of time. It is calculated by multiplying the number of packs of cigarettes smoked per day by the number of years the person has smoked, eg, a 10 pack-year history is equal to smoking 1 pack per day for 10 years or 2 packs per day for 5 years, etc.)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00506987

Sponsors and Collaborators

Schering-Plough

Investigators

Principal Investigator:

Ashley Woodcock, MD

Whythenshawe Hospital, Manchester, UK

More Information

Responsible Party:	Schering-Plough ( Heribert Staudinger, MD - Vice President, Global Clinical Research, Allergy/Respiratory/Immunology )
Study ID Numbers:	P04887, SCH 486757
Study First Received:	July 23, 2007
Last Updated:	January 23, 2008
ClinicalTrials.gov Identifier:	NCT00506987
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Signs and Symptoms
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Cough

ClinicalTrials.gov processed this record on January 16, 2009