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
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014