Study of SCH 527123 in Subjects With Severe Asthma (Study P05109AM1)

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01006161
First received: October 30, 2009
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

Given the strong inhibition of SCH 527123 on neutrophil migration to sites of inflammation, there is a theoretical reason for its use in patients with severe asthma where neutrophils are thought to play a significant role in the pathophysiology of the disease.


Condition Intervention Phase
Asthma
Drug: SCH 527123
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Proof-of-Concept and Dose Range-Finding Study of SCH 527123 in Subjects With Severe Asthma

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Severe asthma exacerbations, pulmonary function test data, and a change in symptoms [ Time Frame: Measured over the duration of the trial. ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: January 2010
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low dose SCH 527123 Drug: SCH 527123
Low dose
Experimental: Medium dose SCH 527123 Drug: SCH 527123
Medium dose
Experimental: High dose SCH 527123 Drug: SCH 527123
High dose
Placebo Comparator: Placebo Drug: SCH 527123
Placebo to match SCH 527123

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject must have severe asthma, be at least 18 to less than or equal to 70 years of age, of either sex, and any race.

Exclusion Criteria:

  • Subject who has been diagnosed with COPD or any other clinically relevant lung disease, other than asthma (eg, cystic fibrosis, pulmonary fibrosis, bronchiectasis).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01006161     History of Changes
Other Study ID Numbers: P05109, EUDRACT No.: 2008-004119-36
Study First Received: October 30, 2009
Last Updated: November 4, 2013
Health Authority: Canada: Health Canada, Therapeutic Products Directorate

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014