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NCT02484664 · ClinicalTrials.gov registry record · Phase 2
COLA: A Pilot Clinical Trial of COX-2 Inhibition in LAM and TSC
A Phase 2 study of Lymphangioleiomyomatosis (LAM), sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT02484664: Completed Phase 2 study of Lymphangioleiomyomatosis (LAM), sponsored by Brigham and Women's Hospital.
NCT02484664 is a Phase 2 study of Lymphangioleiomyomatosis (LAM) that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 12 participants, below the 48-participant average among 3 other Lymphangioleiomyomatosis (LAM) trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02484664, a Phase 2 study of Lymphangioleiomyomatosis (LAM), has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigators will perform a two-center phase I trial of celecoxib (COX-2 inhibitor) administered at 200mg by mouth daily for 6 months. Up to 12 adult women with LAM will be recruited (between 4-8 at each site). The Specific Aims are: Aim 1: To investigate whether, in LAM patients, celecoxib is safe and well tolerated, and has evidence of clinical benefit. Aim 2: To investigate the potential value of a novel biomarker of LAM, quantitative measurement of the number of TSC2 mutant LAM cells per ml of blood, to assess disease severity.
Primary Outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability in LAM patients
Conditions Studied
Interventions
- DRUG Celecoxib
Study Locations (1)
Massachusetts
- Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2016-06-15 |
| Est. Completion | 2018-11-19 |
| Phase | Phase 2 |
What the finished NCT02484664 record still lists
NCT02484664 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 48-participant average among 3 other Lymphangioleiomyomatosis (LAM) trials with a reported enrollment target (75% lower).
The record links to 1 condition, with Lymphangioleiomyomatosis (LAM) appearing as the primary indexed condition, and to 1 intervention - of which Celecoxib is the first listed.
NCT02484664 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02484664 about?
NCT02484664 is a clinical study titled "COLA: A Pilot Clinical Trial of COX-2 Inhibition in LAM and TSC". The investigators will perform a two-center phase I trial of celecoxib (COX-2 inhibitor) administered at 200mg by mouth daily for 6 months. Up to 12 adult women with LAM will be recruited (between 4-8 at each site). The Specific Aims are: Aim 1: To investigate whether, in LAM patients, celecoxib is...
What is the current status of trial NCT02484664?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2016-06-15. Estimated completion is 2018-11-19.
What conditions does trial NCT02484664 study?
This clinical trial studies the following conditions: Lymphangioleiomyomatosis (LAM).
What interventions are being tested in trial NCT02484664?
The interventions under investigation include: Celecoxib (DRUG).
Who is sponsoring clinical trial NCT02484664?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02484664 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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