Trial · Interventional

CompletedPhase 4Results postedRegistry data

Intranasal Oxytocin for the Treatment of Pain Associated With Interstitial Cystitis

NCTNCT00919802Other idUAB0001

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Overview

Status: Completed
Phase: Phase 4
Enrollment: 25 participants (actual)
Sponsor: University of Alabama at Birmingham · Other
Design: Randomized · Double masking
Countries: 1 country
United States
Start: Jun 2010
Primary completion: Sept 2015
Completion: Sept 2015
First posted: 12 Jun 2009 (estimated)
Last update posted: 23 May 2017
Conditions: Interstitial Cystitis

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2010201120122013201420152016

Ph 4
Intranasal Oxytocin for the Treatment of Pain Associated With Interstitial Cystitis
NCT00919802
Jun 2010 to Sept 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

OxytocinDrug
Saline as a nasal sprayOther

Arms2

Active comparator
Oxytocin
Oxytocin, 40 IU intranasally, once
Placebo comparator
Saline as a nasal spray
Saline, 4ml intranasally, once

Primary outcomes1

Outcomes the sponsor listed as primary.

Change From Baseline Measured as Global Response Assessment (GRA) Score at 6 and 24 Hours
Time frame · 6 and 24 hours post drug or placebo administration - the data below reflects 6 hour data
Registry description
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

Secondary outcomes(1)

Secondary Outcome Measures Will Include Change From Baseline in Verbal Reports of Anxiety 6 Hours After Drug/Placebo Administration
Time frame · 6 hours post drug or placebo administration
Registry description
A verbal anxiety report (VAR; 0-10 with 0 being no anxiety and 10 being the worst possible anxiety); a change from baseline measure was calculated for value measured 6 hours post drug/placebo administration

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 6 and 24 hours post drug or placebo administration - the data below reflects 6 hour data

Change From Baseline Measured as Global Response Assessment (GRA) Score at 6 and 24 Hours

Group	Value (units on a scale)	Spread
Oxytocin	.5	.2
Saline as a Nasal Spray	-.1	.2

Secondary and other outcome results(1)

Secondary outcomeMean· 6 hours post drug or placebo administration

Secondary Outcome Measures Will Include Change From Baseline in Verbal Reports of Anxiety 6 Hours After Drug/Placebo Administration

Group	Value (units on a scale)	Spread
Oxytocin	-1.2	.4
Saline as a Nasal Spray	-1.0	.4

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
OxytocinOxytocin, 40 IU intranasally, once Oxytocin: 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.	0 / 25	0 / 25	0 / 25
Saline as a Nasal SpraySaline, 4ml intranasally, once Saline as a nasal spray: 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.	0 / 25	0 / 25	0 / 25

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 19 Years up to 65 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * 19 - 65 years of age * Must meet the current National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) diagnostic criteria for interstitial cystitis and have some degree of continuous daily pain Exclusion Criteria: * Pregnancy * Under the age of 19 * Older that the age of 65 * Breastfeeding women * Uncontrolled hypertension * History of significant cardiac or pulmonary disease (including arrhythmias) * Known allergy to oxytocin * Severe psychiatric disease * Patients who have undergone procedural interventions within the past month related to their interstitial cystitis

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