Study of the Efficacy and Safety of SCH 619734 in Subjects With Chronic Cough From an Unknown Cause (Study P04888AM1)(COMPLETED)
This study has been completed.
Sponsor:
Schering-Plough
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00506545
First received: July 23, 2007
Last updated: October 21, 2009
Last verified: October 2009
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Purpose
This is a randomized, double-blind, placebo-controlled, crossover, single center study of SCH 619734 in subjects with chronic cough from an unknown cause. Subjects will be randomized to receive SCH 619734 or placebo for 7 days with 7 days' follow-up. After a 6 week washout period, subjects will be crossed over to the other treatment. The primary objective is to evaluate the effectiveness of SCH 619734 in reducing cough reflex sensitivity as determined by a challenge with capsaicin, an agent that induces cough.
| Condition | Intervention | Phase |
|---|---|---|
|
Cough |
Drug: SCH 619734 Drug: Placebo Dose 1 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Study of the Efficacy and Safety of SCH 619734 in Subjects With Chronic Idiopathic Cough |
Resource links provided by NLM:
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 of each treatment week (before dosing) and on the last day of each treatment week. [ Time Frame: At Days 7 and 63. ] [ 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 number of coughs on Days -1 and 56 and compared with the total number of coughs on the last day of each treatment week. [ Time Frame: At Days 7 and 63. ] [ Designated as safety issue: No ]
| Enrollment: | 35 |
| Study Start Date: | January 2007 |
| Study Completion Date: | October 2007 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: SCH 619734 |
Drug: SCH 619734
SCH 619734 50-mg capsule each day orally. One week of treatment with 7 days' follow-up; 1 week of crossover treatment with 7 days' follow-up. A 6 week washout period separates treatments.
Other Name: Rolapitant
|
| Placebo Comparator: Placebo |
Drug: Placebo Dose 1
Matching placebo capsule each day orally. One week of treatment with 7 days' follow-up; 1 week of crossover treatment with 7 days' follow-up. A 6 week washout period separates treatments.
|
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
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00506545 History of Changes |
| Other Study ID Numbers: | P04888, SCH 619734 |
| Study First Received: | July 23, 2007 |
| Last Updated: | October 21, 2009 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Additional relevant MeSH terms:
|
Cough Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013