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SCH 619734

Phase 2

Cough | Small molecule | Respiratory |Merck & Company, Inc.|Last Updated: Nov 27, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment35

FDA Designations

No designations recorded

Clinical trial landscape

SCH 619734 · 1 trial · 1 indication

Phase 2 1
NCT00506545Study of the Efficacy and Safety of SCH 619734 in Subjects With Chronic Cough From an Unknown Cause (Study P04888)Cough
COMPLETED35 Analytics
PHASE2COMPLETED
Study of the Efficacy and Safety of SCH 619734 in Subjects With Chronic Cough From an Unknown Cause (Study P04888)
Cough
NCT0050654535
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Study Endpoints

Primary Endpoints

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.
At Days 7 and 63.

Secondary Endpoints

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.
At Days 7 and 63.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SCH 619734EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
SCH 619734DRUGSCH 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.
Placebo Dose 1DRUGMatching 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.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo

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...

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Frequently asked questions about SCH 619734

What is SCH 619734 used for?

SCH 619734 is an investigational small molecule being developed for the treatment of cough. It is being studied in patients with chronic cough from an unknown cause. The drug is in Phase 2 clinical development and is not yet approved by regulatory authorities.

What does SCH 619734 target?

SCH 619734 is a small molecule developed by Merck & Company, Inc. Its specific molecular target has not been disclosed in available clinical trial information. The drug is being investigated for its potential to treat chronic cough of unknown cause.

Who makes SCH 619734?

SCH 619734 is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with chronic cough.

What phase is SCH 619734 in?

SCH 619734 is in Phase 2 clinical development. A Phase 2 study of the drug has been completed, but it remains investigational and has not received FDA approval. The drug is being studied for the treatment of chronic cough from an unknown cause.

What clinical trials is SCH 619734 in?

SCH 619734 has one completed clinical trial, identified as NCT00506545. This Phase 2 study, titled "Study of the Efficacy and Safety of SCH 619734 in Subjects With Chronic Cough From an Unknown Cause (Study P04888)," enrolled 35 participants and was a randomized, double-blind, placebo-controlled trial.

Is SCH 619734 the same as any other drug?

SCH 619734 is the primary name used for this investigational drug in clinical trials. No alternative names have been reported in the available clinical trial information. The drug is being developed by Merck & Company, Inc. for chronic cough.