Additional Minocycline Pleurodesis After Thoracoscopic Procedures for Primary Spontaneous Pneumothorax

This study is currently recruiting participants.

Verified by National Taiwan University Hospital, June 2001

First Received: September 8, 2005 Last Updated: October 19, 2005 History of Changes

Sponsor:	National Taiwan University Hospital
Collaborator:	National Science Council, Taiwan
Information provided by:	National Taiwan University Hospital
ClinicalTrials.gov Identifier:	NCT00154895

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Phase III Study of Additional Minocycline Pleurodesis After Video-Assisted Thoracoscopic Surgery for Primary Spontaneous Pneumothorax

Resource links provided by NLM:

MedlinePlus related topics: Surgery

Drug Information available for: Minocycline Minocycline hydrochloride

U.S. FDA Resources

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

Study ID Numbers:	921204
Study First Received:	September 8, 2005
Last Updated:	October 19, 2005
ClinicalTrials.gov Identifier:	NCT00154895 History of Changes
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:

Anti-Infective Agents
Anti-Bacterial Agents
Minocycline
Respiratory Tract Diseases

Therapeutic Uses
Pleural Diseases
Pharmacologic Actions
Pneumothorax

ClinicalTrials.gov processed this record on February 08, 2010