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Intranasal Oxytocin for the Treatment of Pain Associated With Interstitial Cystitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tim Ness, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00919802
First received: June 9, 2009
Last updated: April 23, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention Phase
Interstitial Cystitis Drug: Oxytocin Other: Saline as a nasal spray Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: Intranasal Oxytocin for the Treatment of Pain Associated With Interstitial Cystitis

Resource links provided by NLM:


Further study details as provided by Tim Ness, MD, University of Alabama at Birmingham:

Primary Outcome Measures:
  • 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 ]
    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 Outcome Measures:
  • 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 ]
    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


Enrollment: 25
Study Start Date: June 2010
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Oxytocin
Oxytocin, 40 IU intranasally, once
Drug: 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.
Other Name: Syntocinon
Placebo Comparator: Saline as a nasal spray
Saline, 4ml intranasally, once
Other: 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.

Detailed Description:

Fifty patients will be enrolled in a double-blinded, placebo-controlled single-dose crossover trial comparing intranasal oxytocin to intranasal saline. At the time of enrollment, patients will complete a series of standardized questionnaires detailing information about their IC-related symptoms at baseline as well as comorbid conditions, coping mechanisms (specifically catastrophizing), and baseline ratings of overall pain, depression, anxiety, and global functioning. Once this information is obtained, the patient will receive a one-time dose of intranasal oxytocin or an equivalent volume of intranasal saline. The patients will be monitored for one hour by a physician investigator for toxicities and efficacy and then contacted for follow-up information at 2, 4, 6, and 24 hours. At each of these time points, the patient will be asked to report a verbal pain report, a verbal anxiety report, the number of voids since last contact with an investigator, and the use of any additional medications for pain control or anxiety. In addition, a global response assessment (GRA) score will be obtained at 6 and 24 hours. The patient will be asked to return within a one week period at which time he/she will receive the alternative intranasal agent. Following the second dose, the patient will be monitored for one hour and contact made at 2, 4, 6, and 24 hours as previously described.

The primary outcome measure will be the GRA score, which will be analyzed using a Chi-square analysis followed by Fischer's exact test. Secondary outcome measures will be analyzed via ANOVA.

If this study indicates that intranasal oxytocin is efficacious for pain control, this could provide for an alternative to current ineffective or invasive treatments for IC-related pain. It is also possible it could eventually be utilized for other forms of chronic pain as well.

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00919802

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Meredith T Robbins, PhD University of Alabama at Birmingham
  More Information

Responsible Party: Tim Ness, MD, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00919802     History of Changes
Other Study ID Numbers: UAB0001
Study First Received: June 9, 2009
Results First Received: December 27, 2016
Last Updated: April 23, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified raw data will be made available on request by contacting contact investigator at tness@uabmc.edu

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tim Ness, MD, University of Alabama at Birmingham:
Interstitial cystitis (IC)
Oxytocin
Bladder
Void

Additional relevant MeSH terms:
Cystitis
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 25, 2017