Study of the Efficacy and Safety of SCH619734 in Subjects with Chronic Idiopathic Cough

• Conditions: Chronic Idiopathic Cough

• Registration Number: EUCTR2006-002164-26-GB
• Lead Sponsor: Schering Plough Research Institute, a division of Schering Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

Subjects must be 18 to <65 years of age, of either sex, and of any race.
Subjects must have a history of 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.
After crossover to the second treatment period, the baseline values for both cough rate and capsaicin challenge (ie, C5) must be within one doubling concentration from the initial Baseline for Treatment Period 1. If the baseline values are not within one doubling concentration, the subject can be reevaluated at a later time point.
Subjects’ clinical laboratory tests (CBC, blood chemistries, and urinalysis) must be within normal limits or clinically acceptable to the investigator/sponsor.
Subjects must be willing to give written informed consent and able to adhere to dose and visit schedules.
Female subjects of childbearing potential must be using a medically accepted method of birth control prior to Baseline (Visit 1) and agree to continue its use during the study and after the study until the next menses or have been surgically sterilized (eg, hysterectomy). Females of childbearing potential should be counseled in the appropriate use of birth control while in this study. Females who are not currently sexually active must agree and consent to use one of the above-mentioned methods should they become sexually active while participating in the study.
Female subjects of childbearing potential must have a negative serum pregnancy test (beta-hCG) at Baseline.

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

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 (Visit 1). 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.
Subjects with a history of hypersensitivity to the study medications or to their excipients.
Subjects who have used any study medication, including placebo, in an investigational protocol within 30 days prior to the baseline visit (Visit 1).
Women who are breast-feeding, pregnant, or intend to become pregnant.
Subjects who are family members of the investigational study staff involved with this study.
Subjects previously enrolled into this study (ie, signed informed consent).
Subjects whose ability, in the opinion of the investigator or designee, to provide informed consent is compromised.
Subjects with a history of noncompliance with medications or treatment protocols, or with a history of drug abuse.
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.)

Study & Design

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