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NCT00971620 · ClinicalTrials.gov registry record · Phase 2
Randomized Pilot Study for the Treatment of Cutaneous Leiomyomas With Botulinum Toxin
A Phase 2 study of Hereditary Leiomyomatosis and Renal Cell Cancer and Cutaneous Leiomyomas, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT00971620 is a Phase 2 study of Hereditary Leiomyomatosis and Renal Cell Cancer and Cutaneous Leiomyomas that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 18 participants. The trial reports 1 study location across 1 state.
The verdict
NCT00971620, a Phase 2 study of Hereditary Leiomyomatosis and Renal Cell Cancer and Cutaneous Leiomyomas, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
Cutaneous leiomyomas are benign tumors of smooth muscle origin. They can be very painful, and current treatments for the tumors and for the associated pain do not produce satisfactory results. One potential treatment for localized severe muscle pain involves injections with botulinum toxin A. This study will investigate the effectiveness, side effects, and dosage of botulinum toxin A (BOTOX) as a treatment for patients with pain associated with cutaneous leiomyomas. This study will include 18 subjects, all of whom will be 18 years of age and older, who have pain associated with cutaneous leiomyomas. For the 24-week study, patients will be randomly assigned to one of two treatment groups. Neither the study team nor the patient will know to which group patients have been assigned. Before the study begins, all participants must provide a full medical history for research and evaluation purposes, fill out pain and quality-of-life questionnaires, and undergo an ice test in which researchers will apply ice to the site of the cutaneous leiomyomas and ask participants to evaluate the level of pain before and after ice application. Both groups will be required to keep a pain diary throughout the study to record their level of pain on a daily basis, and will be asked to avoid or restrict the use of specific medications or other remedies to treat the pain. At the first visit (Week 0), one group will receive a prescribed dose of botulinum toxin A, which will be administered as an injection into the leiomyoma, and the other (control) group will receive a placebo injection of a saline solution. Patients will return 4 weeks later, at which time they will undergo a medical examination, and the ice test, and complete questionnaires to assess responses and level of pain. Patients will return in Week 12, at which time the group assignment will be revealed (un-blinded) to investigators and patients. Patients who received placebo injections will be offered the opportunity to receive
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL Botulinum toxin type A
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2008-11-17 |
| Est. Completion | 2016-10-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00971620
The ClinicalTrials.gov registry entry for NCT00971620 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Hereditary Leiomyomatosis and Renal Cell Cancer appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00971620 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00971620 about?
NCT00971620 is a clinical study titled "Randomized Pilot Study for the Treatment of Cutaneous Leiomyomas With Botulinum Toxin". Cutaneous leiomyomas are benign tumors of smooth muscle origin. They can be very painful, and current treatments for the tumors and for the associated pain do not produce satisfactory results. One potential treatment for localized severe muscle pain involves injections with botulinum toxin A. This s...
What is the current status of trial NCT00971620?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2008-11-17. Estimated completion is 2016-10-12.
What conditions does trial NCT00971620 study?
This clinical trial studies the following conditions: Hereditary Leiomyomatosis and Renal Cell Cancer, Cutaneous Leiomyomas.
What interventions are being tested in trial NCT00971620?
The interventions under investigation include: Placebo (OTHER), Botulinum toxin type A (BIOLOGICAL).
Who is sponsoring clinical trial NCT00971620?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00971620 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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