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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT00919802 |
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Date of registration:
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09/06/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Intranasal Oxytocin for the Treatment of Pain Associated With Interstitial Cystitis
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Scientific title:
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Intranasal Oxytocin for the Treatment of Pain Associated With Interstitial Cystitis |
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Date of first enrolment:
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June 2010 |
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Target sample size:
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25 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00919802 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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Meredith T Robbins, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Alabama at Birmingham |
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Key inclusion & exclusion criteria
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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
Age minimum:
19 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Interstitial Cystitis
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Intervention(s)
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Drug: Oxytocin
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Other: Saline as a nasal spray
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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