- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00381147
Use of Clarithromycin in Mustard-Induced Bronchiolitis
January 6, 2009 updated by: Baqiyatallah Medical Sciences University
Phase III, Randomized, Double Blind Study of Low Dose Long Term Clarithromycin Versus Placebo in Treatment of Chronic Pulmonary Lesions Due to Sulfur Mustard
We looked for the effectiveness of low-dose long-term prescription of clarithromycin in mustard-induced chronic pulmonary lesions, especially bronchiolitis obliterans
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tehran, Iran, Islamic Republic of
- Baqiyatallah Medical Sciences University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- His/her own will to participate
- Documented chemical exposure
- Clinical, spirometric and radiological findings were compatible with BO on High Resolution Computed Tomography (HRCT)
Exclusion Criteria:
- any drug reactions during the trial
- history of sensitivity to macrolides
- diarrhea, gray stool, jaundice, eosinophilia, acute cholestatic hepatitis, pruritis, dark urine, abdominal pain, osteomatosis, depression, taste change, behavioural changes, early fatigue, odynophagia, glossitis , dizziness
- co-adminstration of: terfenadine, theophylline, carbamazepine, ergotamine, dihydroergotamine, warfarin, cisapride, digoxin, triazolam, phenytoin, steroids, any immunosuppressive, any systemic antibiotics
- using drugs that he/she cannot discontinue
- using drugs with potential interaction
- subject will to exit from the trial
- history of lobe resection of lung
- history of exacerbation in the last month prior to the beginning of trial
- continuous need to oxygen
- use of corticosteroids in last week prior to the trial beginning
- Radiographic evidence of pneumonia, active tuberculosis, lung carcinoma, or an infection that necessitated the use of an antibiotic
- exacerbating of subjects
- creatinine srum level more than normal
- increasing ALT, AST levels
- total bilirubin more twice than normal
- subjects who did not use their drugs properly
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
September 26, 2006
First Submitted That Met QC Criteria
September 26, 2006
First Posted (ESTIMATE)
September 27, 2006
Study Record Updates
Last Update Posted (ESTIMATE)
January 7, 2009
Last Update Submitted That Met QC Criteria
January 6, 2009
Last Verified
September 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Bronchial Diseases
- Lung Diseases, Obstructive
- Bronchitis
- Bronchiolitis
- Bronchiolitis Obliterans
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Bacterial Agents
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Protein Synthesis Inhibitors
- Clarithromycin
Other Study ID Numbers
- S-340-14-6-1-PU-11
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Clarithromycin
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AbbottCompletedAcute Bacterial Exacerbation of Chronic Bronchitis (ABECB).United States, Canada, Puerto Rico
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Memorial Sloan Kettering Cancer CenterCompletedLymphomaUnited States
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HK inno.N CorporationCompletedHealthyKorea, Republic of
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Lynn Marie TrottiCompletedNarcolepsy | Idiopathic Hypersomnia | HypersomniaUnited States
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University Medical Center GroningenCompletedMultidrug-resistant Tuberculosis | Extensively Drug-resistant TuberculosisNetherlands
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AbbottEilafCompletedRespiratory Tract InfectionEgypt, Saudi Arabia
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University of KarachiCenter for Bioequivalence Studies and Clinical Research; Merck Pvt. Ltd, PakistanCompletedHealthy Volunteers | Bioequivalence StudyPakistan
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Assistance Publique - Hôpitaux de ParisCompletedHelicobacter Pylori InfectionFrance