Intranasal Oxytocin for the Treatment of Pain Associated With Interstitial Cystitis
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Intranasal Oxytocin for the Treatment of Pain Associated With Interstitial Cystitis|
- Our primary outcome measure will be the global response assessment(GRA)score [ Time Frame: 6 and 24 hours post drug or place administration ] [ Designated as safety issue: No ]
- Secondary outcome measures will include verbal reports of anxiety and pain, micturition frequency, and concomitant medication use for pain and/or anxiety. [ Time Frame: One week ] [ Designated as safety issue: No ]
|Study Start Date:||June 2010|
|Estimated Study Completion Date:||September 2015|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Oxytocin
Oxytocin, 40 IU intranasally, once
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00919802
|Contact: Meredith T Robbins, PhDemail@example.com|
|United States, Alabama|
|University of Alabama at Birmingham||Recruiting|
|Birmingham, Alabama, United States, 35294|
|Contact: Meredith T Robbins, PhD 205-996-7134 firstname.lastname@example.org|
|Principal Investigator: Meredith T Robbins, PhD|
|Sub-Investigator: Michael A Froelich, MD, MS|
|Sub-Investigator: Keith Lloyd, MD|
|Sub-Investigator: Timothy J Ness, MD, PhD|
|Principal Investigator:||Meredith T Robbins, PhD||University of Alabama at Birmingham|