AsthmaPhase 2NCT00404313
The Effect of MK0633 in Patients With Chronic Asthma (0633-007)
A Phase 2 study testing MK0633 in people with Asthma, run by Merck Sharp & Dohme LLC.
Trial summary
A clinical study to evaluate the efficacy and safety of MK0633 in adult patients with chronic asthma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Asthma
- What is being tested?
- MK0633
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 688 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Jun 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Parallel-Group, Dose-Ranging Study of MK0633 in Adult Patients With Chronic Asthma
A clinical study to evaluate the efficacy and safety of MK0633 in adult patients with chronic asthma.
- Conditions
- Asthma
- Being tested
- MK0633, Comparator: placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Comparator: placeboDrug
Placebo to MK0633 10 mg, 50 mg, or 100 mg tablets once daily for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | MK0633 10 mg Receives: Drug: MK0633 |
| 2 | Experimental | MK0633 50 mg Receives: Drug: MK0633 |
| 3 | Experimental | MK0633 100 mg Receives: Drug: MK0633 |
| 4 | Placebo comparator | placebo Receives: Drug: Comparator: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary function test data measured over 6 weeks
Measured: 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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2006 (estimated)
- Study startJan 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 688 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00404313
- Sponsor's protocol ID
- 0633-007
- Other IDs
- MK0633-007, 2006_553
- Status last verified
- Oct 2015
- First submitted
- 21 Nov 2006
- Last updated
- 20 Oct 2015
- Results posted
- No
Publications
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.
PubMed 21945511
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Parallel-Group, Dose-Ranging Study of MK0633 in Adult Patients With Chronic Asthma
- ClinicalTrials.gov ID
- NCT00404313
- Acronym / sponsor ID
- 0633-007
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 688 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 28 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A clinical study to evaluate the efficacy and safety of MK0633 in adult patients with chronic asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MK0633MK0633 10 mg |
| 2 | Experimental | Drug: MK0633MK0633 50 mg |
| 3 | Experimental | Drug: MK0633MK0633 100 mg |
| 4 | Placebo comparator | Drug: Comparator: placeboplacebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MK0633Patients 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 | Drug | 1, 2, 3 |
| Comparator: placeboPlacebo to MK0633 10 mg, 50 mg, or 100 mg tablets once daily for 6 weeks | Drug | 4 |
Primary outcome
Pulmonary function test data measured over 6 weeks
Time frame: 6 weeks
1 secondary outcome
Overall daytime and nighttime symptoms score, beta-agonist use, asthma exacerbations, asthma-specific quality of life questionnaire score, measured over 6 weeks
Time frame: 6 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2015.
- Results publication: PubMed 21945511Wasfi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MK0633 in people with Asthma, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary function test data measured over 6 weeks (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00404313, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2015.