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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: Completed Phase 4 study, sponsored by University of Alabama at Birmingham.
NCT00919802 is a Phase 4 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 25 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
This is a seven-point symmetric scale previously validated for use in IC studies in which patients are asked relative to baseline (over the last 6 hours for purposes of this study), -3 -are you markedly worse, -2 -moderately worse, -1 -slightly worse, 0-no change, +1-slightly improved, +2-moderately improved, or +3-markedly improved. A +2 or +3 can be defined categorically as a positive treatment response
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 |
What the finished NCT00919802 record still lists
NCT00919802 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Oxytocin is the first listed.
NCT00919802 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00919802's enrollment target sits among peer trials
25 1669th of 2000 higher than 302 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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