NCT00154895

Brief Summary

To test if additional minocycline pleurodesis after thoracoscopic procedures can reduce the rates of ipsilateral recurrence for patients with primary spontaneous pneumothorax.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2001

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2001

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

October 20, 2005

Status Verified

June 1, 2001

First QC Date

September 8, 2005

Last Update Submit

October 19, 2005

Conditions

Pneumothorax

Keywords

minocyclinepleurodesisthoracoscopyprimary spontaneous pneumothoraxclinical trial

Outcome Measures

Primary Outcomes (1)

  • The primary end point was rates of ipsilateral recurrence after the operation.

Secondary Outcomes (4)

  • safety of minocycline

  • early postoperative results of minocycline

  • long-term complication of minocycline

  • long-term effect on pulmonary function of minocycline pleurodesis

Interventions

intrapleural minocycline instillationDRUG

Eligibility Criteria

Age10 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • All patients requiring VATS caused by recurrent, persistent, or contralateral spontaneous pneumothorax as well as by spontaneous hemopneumothorax were eligible for this study.

You may not qualify if:

  • greater than 50 years of age, with underlying pulmonary disease, previous ipsilateral thoracic operation, allergy to tetracycline or minocycline, and unwilling to receive randomization.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yung-Chie Lee

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Pneumothoraxcyclopia sequence

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract Diseases

Study Officials

  • Yung-Chie Lee, MD, PhD

    Natinal Taiwan University Hospital

    STUDY CHAIR

Central Study Contacts

Jin-Shing Chen, MD, PhD

CONTACT

886-2-23123456cjs@ha.mc.ntu.edu.tw

Yung-Chie Lee, MD, PhD

CONTACT

886-2-23123456wuj@ha.mc.ntu.edu.tw

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

June 1, 2001

Study Completion

March 1, 2005

Last Updated

October 20, 2005

Record last verified: 2001-06

Locations

TW(1)