ClinicalTrials.gov
ClinicalTrials.gov Menu

Intranasal Oxytocin for the Treatment of Pain Associated With Interstitial Cystitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00919802
Recruitment Status : Completed
First Posted : June 12, 2009
Results First Posted : May 23, 2017
Last Update Posted : May 23, 2017
Sponsor:
Information provided by (Responsible Party):
Tim Ness, MD, University of Alabama at Birmingham

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Interstitial Cystitis
Interventions: Drug: Oxytocin
Other: Saline as a nasal spray

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Protocol Open to Accrual: June 2010, Primary Completion Date: September 2015 and Study Completion Date: September 2015. Recruitment location: University of Alabama at Birmingham.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The major goal of this project was to evaluate the efficacy of intranasal oxytocin in relieving bladder pain in a cohort of patients with interstitial cystitis.

Reporting Groups
  Description
Intranasal Oxytocin, Followed by Intranasal Saline

Oxytocin, 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. 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. The patient will be asked to return within a one-week period at which time the patient 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.

Intranasal Saline Followed With Intranasal Oxytocin

Saline, 4ml intranasally, once

Patients will be randomized to receive saline as a nasal spray: A single dose of saline will be dispensed in a random fashion to subjects.

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. The patient will be asked to return within a one-week period at which time they will receive the alternative intranasal agent, Oxytocin a single dose of oxytocin 40 IU (20 IU to each nostril). 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.


Participant Flow for 2 periods

Period 1:   First Intervention - (24 Hours)
    Intranasal Oxytocin, Followed by Intranasal Saline   Intranasal Saline Followed With Intranasal Oxytocin
STARTED   12   13 
COMPLETED   12   13 
NOT COMPLETED   0   0 

Period 2:   Second Intervention - (24 Hours)
    Intranasal Oxytocin, Followed by Intranasal Saline   Intranasal Saline Followed With Intranasal Oxytocin
STARTED   12   13 
COMPLETED   12   13 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
All Study Participants Patients will be randomized to receive a single dose of oxytocin 40 IU (20 IU to each nostril) or saline. 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. The patient will be asked to return within a one-week period at which time the patient 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.

Baseline Measures
   All Study Participants 
Overall Participants Analyzed 
[Units: Participants]
 25 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      25 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      25 100.0% 
Male      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      25 100.0% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      1   4.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      1   4.0% 
White      23  92.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   25 


  Outcome Measures

1.  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 ]

2.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Timothy Ness
Organization: UAB
phone: 205-975-9643
e-mail: tness@uabmc.edu



Responsible Party: Tim Ness, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00919802     History of Changes
Other Study ID Numbers: UAB0001
First Submitted: June 9, 2009
First Posted: June 12, 2009
Results First Submitted: December 27, 2016
Results First Posted: May 23, 2017
Last Update Posted: May 23, 2017