Corticosteroids in the Treatment of Tuberculous Pleurisy
This study has been completed.
Sponsor:
Guangxi Medical University
Collaborators:
National Natural Science Foundation of China
Ministry of Education, China
Bureau of Science and Technology of Guangxi Province, China
Information provided by:
Guangxi Medical University
ClinicalTrials.gov Identifier:
NCT00338793
First received: June 19, 2006
Last updated: August 25, 2008
Last verified: August 2008
| Tracking Information | |||||||||||||
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| First Received Date ICMJE | June 19, 2006 | ||||||||||||
| Last Updated Date | August 25, 2008 | ||||||||||||
| Start Date ICMJE | July 2006 | ||||||||||||
| Primary Completion Date | Not Provided | ||||||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
| Change History | Complete list of historical versions of study NCT00338793 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Corticosteroids in the Treatment of Tuberculous Pleurisy | ||||||||||||
| Official Title ICMJE | A Multicenter, Placebo-Controlled, Double-Blind, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Corticosteroids for Treatment of Patients With Tuberculous Pleurisy | ||||||||||||
| Brief Summary | Tuberculous pleurisy is associated with inflammation and fibrosis. Adjunctive corticosteroids are used for tuberculous pleurisy because their anti-inflammatory effect is thought to minimise pleural reactivity and thereby reduce residual pleural thickening. The purpose is to evaluate the efficacy and safety of oral prednisolone for treatment of adult patients with tuberculous pleurisy. |
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| Detailed Description | Not Provided | ||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||
| Study Phase | Not Provided | ||||||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
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| Condition ICMJE | Tuberculous Pleurisy | ||||||||||||
| Intervention ICMJE | Drug: prednisolone | ||||||||||||
| Study Arm (s) | Not Provided | ||||||||||||
| Publications * | Not Provided | ||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||
| Estimated Enrollment ICMJE | 1500 | ||||||||||||
| Completion Date | August 2008 | ||||||||||||
| Primary Completion Date | Not Provided | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | 18 Years and older | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | China | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT00338793 | ||||||||||||
| Other Study ID Numbers ICMJE | Shi-TB-01 | ||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||
| Responsible Party | Not Provided | ||||||||||||
| Study Sponsor ICMJE | Guangxi Medical University | ||||||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Guangxi Medical University | ||||||||||||
| Verification Date | August 2008 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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