CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 25 enrolled
Drug / intervention
Oxytocin +1 moredrug
Likely dose
Oxytocin 40 IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00919802
NCT00919802Phase 4Completed

Intranasal Oxytocin for the Treatment of Pain Associated With Interstitial Cystitis

University of Alabama at Birmingham·interventional·Posted Jun 12, 2009·Updated May 23, 2017

In Brief

A Phase 4 clinical trial evaluating Oxytocin and Saline as a nasal spray for Interstitial Cystitis. Completed, enrolled 25 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 12, 2009
Enrollment StartJun 1, 2010
Primary CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 17.1 years ago

Interventions

Oxytocindrug

A single dose of oxytocin 40 IU (20 IU to each nostril) will be dispensed in a random fashion to subjects. A log will be kept so that the subject will receive a single does of saline as an alternate agent on the second day if needed.

Saline as a nasal sprayother

A single dose of saline will be dispensed in a random fashion to subjects. A log will be kept so that the subject will receive a single does of oxytocin 40 IU as an alternate agent on the second day if needed.