NCT00404313

Brief Summary

A clinical study to evaluate the efficacy and safety of MK0633 in adult patients with chronic asthma.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
688

participants targeted

Target at P75+ for phase_2 asthma

Timeline
Completed

Started Jan 2008

Typical duration for phase_2 asthma

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2006

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 28, 2006

Completed
1.1 years until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

October 20, 2015

Status Verified

October 1, 2015

Enrollment Period

1.4 years

First QC Date

November 21, 2006

Last Update Submit

October 19, 2015

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Pulmonary function test data measured over 6 weeks

    6 weeks

Secondary Outcomes (1)

  • Overall daytime and nighttime symptoms score, beta-agonist use, asthma exacerbations, asthma-specific quality of life questionnaire score, measured over 6 weeks

    6 weeks

Study Arms (4)

1

EXPERIMENTAL

MK0633 10 mg

Drug: MK0633

2

EXPERIMENTAL

MK0633 50 mg

Drug: MK0633

3

EXPERIMENTAL

MK0633 100 mg

Drug: MK0633

4

PLACEBO COMPARATOR

placebo

Drug: Comparator: placebo

Interventions

MK0633DRUG

Patients will receive 10 mg, 50 mg, or 100 mg MK0633 tablets once daily for 6 weeks. There will be 2 week period during which all patients will receive placebo to MK0633

123
Comparator: placeboDRUG

Placebo to MK0633 10 mg, 50 mg, or 100 mg tablets once daily for 6 weeks

4

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Documented clinical history of symptoms of chronic asthma, including dyspnea, wheezing, chest tightness, cough, and/or sputum production
  • Males and females 18-70 years of age

You may not qualify if:

  • History of kidney or chronic liver disease
  • Recent history of heart problems within the past 3 months
  • Evidence of another clinically significant, active lung disorder such as bronchiectasis or COPD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Wasfi YS, Villaran C, de Tilleghem Cle B, Smugar SS, Hanley WD, Reiss TF, Knorr BA. The efficacy and tolerability of MK-0633, a 5-lipoxygenase inhibitor, in chronic asthma. Respir Med. 2012 Jan;106(1):34-46. doi: 10.1016/j.rmed.2011.08.019. Epub 2011 Sep 25.

    PMID: 21945511RESULT

MeSH Terms

Conditions

Asthma

Interventions

MK-0633 p-toluenesulfonate

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2006

First Posted

November 28, 2006

Study Start

January 1, 2008

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

October 20, 2015

Record last verified: 2015-10