Additional Minocycline Pleurodesis After Thoracoscopic Procedures for Primary Spontaneous Pneumothorax
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2001 by National Taiwan University Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
National Taiwan University Hospital
Collaborator:
National Science Council, Taiwan
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00154895
First received: September 8, 2005
Last updated: October 19, 2005
Last verified: June 2001
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Purpose
To test if additional minocycline pleurodesis after thoracoscopic procedures can reduce the rates of ipsilateral recurrence for patients with primary spontaneous pneumothorax.
| Condition | Intervention | Phase |
|---|---|---|
|
Pneumothorax |
Drug: intrapleural minocycline instillation |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase III Study of Additional Minocycline Pleurodesis After Video-Assisted Thoracoscopic Surgery for Primary Spontaneous Pneumothorax |
Resource links provided by NLM:
Further study details as provided by National Taiwan University Hospital:
Primary Outcome Measures:
- The primary end point was rates of ipsilateral recurrence after the operation.
Secondary Outcome Measures:
- safety of minocycline
- early postoperative results of minocycline
- long-term complication of minocycline
- long-term effect on pulmonary function of minocycline pleurodesis
| Estimated Enrollment: | 200 |
| Study Start Date: | June 2001 |
| Estimated Study Completion Date: | March 2005 |
Show Detailed Description Eligibility| Ages Eligible for Study: | 10 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- All patients requiring VATS caused by recurrent, persistent, or contralateral spontaneous pneumothorax as well as by spontaneous hemopneumothorax were eligible for this study.
Exclusion Criteria:
- greater than 50 years of age, with underlying pulmonary disease, previous ipsilateral thoracic operation, allergy to tetracycline or minocycline, and unwilling to receive randomization.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00154895
Contacts
| Contact: Jin-Shing Chen, MD, PhD | 886-2-23123456 ext 5178 | cjs@ha.mc.ntu.edu.tw |
| Contact: Yung-Chie Lee, MD, PhD | 886-2-23123456 ext 5070 | wuj@ha.mc.ntu.edu.tw |
Locations
| Taiwan | |
| Yung-Chie Lee | Recruiting |
| Taipei, Taiwan, 100 | |
| Contact: Jin-Shing Chen, MD, PhD 886-2-23123456 ext 5178 cjs@ha.mc.ntu.edu.tw | |
| Sub-Investigator: Jin-Shing Chen, MD, PhD | |
| Principal Investigator: Yung-Chie Lee, MD, PhD | |
Sponsors and Collaborators
National Taiwan University Hospital
National Science Council, Taiwan
Investigators
| Study Chair: | Yung-Chie Lee, MD, PhD | Natinal Taiwan University Hospital |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00154895 History of Changes |
| Other Study ID Numbers: | 921204 |
| Study First Received: | September 8, 2005 |
| Last Updated: | October 19, 2005 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by National Taiwan University Hospital:
|
minocycline pleurodesis thoracoscopy primary spontaneous pneumothorax clinical trial |
Additional relevant MeSH terms:
|
Pneumothorax Pleural Diseases Respiratory Tract Diseases Minocycline |
Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013