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NCT00711087 · ClinicalTrials.gov registry record · Phase 2
Botox-A Injection to Improve Bladder Function in Early Spinal Cord Injury (#H-20344)
A Phase 2 study, sponsored by Baylor College of Medicine.
- Terminated
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
NCT00711087 is a Phase 2 study that was terminated before completion, run by Baylor College of Medicine. The registered enrollment target is 1 participants.
The verdict
NCT00711087, a Phase 2 study, was terminated before completion, sponsored by Baylor College of Medicine.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
Study Summary
The purpose of this study is to see what the effect of Botox has on bladder function for those who have recently suffered spinal cord injury. We also will study bladder tissue levels of NGF (nerve growth factor) that can tell us how the nerves to the bladder are healing after injury. Consenting male and female cervical and high thoracic (T10 and above) SCI patients will be identified within the first 6-7 weeks after SCI and randomized to two external urethral sphincter injection groups. Each group will be injected within 8 weeks after SCI (Day 0) and 3 months later (Day 90). The injection paradigm will consist of: Group 1-100 units of BTX-A (Botox®, Allergan Inc., Irvine, CA) on Day 0 and 100 units of BTX-A on Day 90; Group 2-sham saline injections on both Day 0 and Day 90. Injections will be performed under local anesthesia using standard flexible cystoscopic equipment. Use of placebo is justified because: 1. there have been documentation of nerve desensitization with dry needling (i.e. acupuncture) and wet needling (i.e. saline)--therefore, to truly demonstrate benefit of Botox over just the needle insertion into the sphincter muscle or injection of the diluent saline, a sham saline injection group is included, 2. the injection procedure itself is minimally invasive and not expected to result in any complications. Subjects who qualify and have signed the informed consent document will be randomized into two groups, those receiving the BTX-A and those receiving placebo. Blinding will be performed by the TIRR pharmacy department who will provide Botox and placebo in identical syringes so that the treating staff will be blinded. Pharmacists will ensure patients receive the same agent at the time of the second injection. Unblinding will occur at the end of the study or if complications necessitate breaking of the code. Both groups will undergo urodynamic testing to document before and after treatment data. Bladder biopsies will be taken prior to treatment in both g
Interventions
- DRUG BOTOX-A
- OTHER Saline injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2007-07 |
| Est. Completion | 2010-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00711087
The ClinicalTrials.gov registry entry for NCT00711087 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which BOTOX-A is the first listed.
NCT00711087 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00711087 about?
NCT00711087 is a clinical study titled "Botox-A Injection to Improve Bladder Function in Early Spinal Cord Injury (#H-20344)". The purpose of this study is to see what the effect of Botox has on bladder function for those who have recently suffered spinal cord injury. We also will study bladder tissue levels of NGF (nerve growth factor) that can tell us how the nerves to the bladder are healing after injury. Consenting mal...
What is the current status of trial NCT00711087?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2007-07. Estimated completion is 2010-02.
What interventions are being tested in trial NCT00711087?
The interventions under investigation include: BOTOX-A (DRUG), Saline injection (OTHER).
Who is sponsoring clinical trial NCT00711087?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
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