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NCT00919802 · ClinicalTrials.gov registry record · Phase 4
Intranasal Oxytocin for the Treatment of Pain Associated With Interstitial Cystitis
A Phase 4 study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 4
- Development phase
- 25
- Enrollment target
NCT00919802 is a Phase 4 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 25 participants.
The verdict
NCT00919802, a Phase 4 study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 25 participants
- Enrollment target
Study Summary
Anecdotal evidence suggests female patients with painful bladder disorder interstitial cystitis (IC) can experience a significant attenuation of their systems while breastfeeding. Since it has been shown that postpartum lactation is a time associated with decreased levels of stress, and stress has been shown to exacerbate IC-related pain, the investigators have developed an interest in the effects of the hormones involved in postpartum lactation on stress and pain. Based on a series of pre-clinical experiments, the investigators believe the hormone oxytoxin has both analgesic and anxiolytic properties which make it a potentially useful agent for the treatment of stress-exacerbated chronic pain syndrome such as IC. Therefore, the investigators propose a double-blinded, placebo-controlled crossover trial of intranasal oxytocin vs. intranasal saline for bladder pain in a cohort of patients with IC and some degree of continuous, daily pain.
Interventions
- DRUG Oxytocin
- OTHER Saline as a nasal spray
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2010-06 |
| Est. Completion | 2015-09 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00919802
The ClinicalTrials.gov registry entry for NCT00919802 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Oxytocin is the first listed.
NCT00919802 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00919802 about?
NCT00919802 is a clinical study titled "Intranasal Oxytocin for the Treatment of Pain Associated With Interstitial Cystitis". Anecdotal evidence suggests female patients with painful bladder disorder interstitial cystitis (IC) can experience a significant attenuation of their systems while breastfeeding. Since it has been shown that postpartum lactation is a time associated with decreased levels of stress, and stress has b...
What is the current status of trial NCT00919802?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 25 participants. The study started on 2010-06. Estimated completion is 2015-09.
What interventions are being tested in trial NCT00919802?
The interventions under investigation include: Oxytocin (DRUG), Saline as a nasal spray (OTHER).
Who is sponsoring clinical trial NCT00919802?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
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