Montelukast Post-Marketing Comparative Study With Theophyline Added to Inhaled Corticosteroid
Overview[ - collapse ][ - ]
| Purpose | A clinical study explores the safety and efficacy of montelukast and to compare the safety and efficacy of montelukast with those of theophylline in pediatric bronchial asthma patients when they are used in conjunction with inhaled steroids. |
|---|---|
| Condition | Asthma |
| Intervention | Drug: montelukast Drug: Theophylline |
| Phase | Phase 4 |
| Sponsor | Merck Sharp & Dohme Corp. |
| Responsible Party | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier | NCT00756418 |
| First Received | September 19, 2008 |
| Last Updated | September 19, 2008 |
| Last verified | September 2008 |
Tracking Information[ + expand ][ + ]
| First Received Date | September 19, 2008 |
|---|---|
| Last Updated Date | September 19, 2008 |
| Start Date | June 2003 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures | Improvement of AM PEF over first 2 Weeks [Time Frame: Over first 2 Weeks] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | Montelukast Post-Marketing Comparative Study With Theophyline Added to Inhaled Corticosteroid |
|---|---|
| Official Title | A Randomized Open-Label Comparative Study of Montelukast Versus Theophylline Added to Inhaled Corticosteroid in Pediatric Patients With Bronchial Asthma |
| Brief Summary | A clinical study explores the safety and efficacy of montelukast and to compare the safety and efficacy of montelukast with those of theophylline in pediatric bronchial asthma patients when they are used in conjunction with inhaled steroids. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Asthma |
| Intervention | Drug: montelukast montelukast 5 mg QD 4-weeks. Other Names: MK0476Drug: Theophylline Theophylline 100 to 200 mg BID 4-weeks. |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 84 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | August 2004 |
| Eligibility Criteria | Inclusion Criteria: - Pediatric Bronchial Asthma Patients Aged 6 To 14 Years (At The Beginning Of The Treatment Period) - The Severity Must Be Mild, Moderate Or Severe, Persistent Bronchial Asthma - The Patient Must Have Symptoms That Can Be Used As Efficacy Variables (Such As Repeated Coughing And Mild Or Moderate Asthma Attacks) During The Observation Period, And Must Be Using Inhaled Steroids Exclusion Criteria: - Patient Using Anti-Asthma Treatment Or Therapy Including corticosteroids Or Oral Anti-Allergic Drugs - Patient With Complications That Will Impair The Judgment Of Efficacy Of This Drug - Patient With Convulsive Disorders Such As Epilepsy Or Such A History - Patient With Liver Disease, Renal Impairment, Heart Disease Or Such Other Complication |
| Gender | Both |
| Ages | 6 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00756418 |
|---|---|
| Other Study ID Numbers | 2008_027 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Merck Sharp & Dohme Corp. |
| Study Sponsor | Merck Sharp & Dohme Corp. |
| Collaborators | Not Provided |
| Investigators | Study Director: Medical Monitor Merck Sharp & Dohme Corp. |
| Verification Date | September 2008 |