Intranasal Oxytocin for the Treatment of Pain Associated With Interstitial Cystitis

NCT00919802 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: UAB0001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Interstitial Cystitis

Keywords

Interstitial cystitis (IC); Oxytocin; Bladder; Void

Outcome Measures

Primary Outcomes (1)

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

  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

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

Secondary Outcomes (1)

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

  6 hours post drug or placebo administration

Study Arms (2)

Oxytocin

ACTIVE COMPARATOR

Oxytocin, 40 IU intranasally, once

Drug: Oxytocin

Saline as a nasal spray

PLACEBO COMPARATOR

Saline, 4ml intranasally, once

Other: Saline as a nasal spray

Interventions

Oxytocin DRUG

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.

Also known as: Syntocinon

Oxytocin

Saline as a nasal spray OTHER

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.

Saline as a nasal spray

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

Oxytocin; Sodium Chloride

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Timothy Ness
• Organization: UAB

tness@uabmc.edu

205-975-9643

Study Officials

• Meredith T Robbins, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 9, 2009
• First Posted: June 12, 2009
• Study Start: June 1, 2010
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: May 23, 2017
• Results First Posted: May 23, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)