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Trial record 25 of 61 for:    (complementary OR alternative) medicine AND (woman OR women OR female) | pain

Intranasal Oxytocin for the Treatment of Pain Associated With Interstitial Cystitis

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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
Enrollment 25
Recruitment Details 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 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.
Arm/Group Title Intranasal Oxytocin, Followed by Intranasal Saline Intranasal Saline Followed With Intranasal Oxytocin
Hide Arm/Group Description

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.

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.

Period Title: First Intervention - (24 Hours)
Started 12 13
Completed 12 13
Not Completed 0 0
Period Title: Second Intervention - (24 Hours)
Started 12 13
Completed 12 13
Not Completed 0 0
Arm/Group Title All Study Participants
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
<=18 years
0
   0.0%
Between 18 and 65 years
25
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
25
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
25
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants
25
1.Primary Outcome
Title Change From Baseline Measured as Global Response Assessment (GRA) Score at 6 and 24 Hours
Hide Description 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
Time Frame 6 and 24 hours post drug or placebo administration - the data below reflects 6 hour data
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxytocin Saline as a Nasal Spray
Hide Arm/Group Description:

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. 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.

Saline, 4ml intranasally, once

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.

Overall Number of Participants Analyzed 25 25
Mean (Standard Error)
Unit of Measure: units on a scale
.5  (.2) -.1  (.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oxytocin, Saline as a Nasal Spray
Comments Global Response Assessment (GRA) scores were obtained 6 and 24 hours post oxytocin or saline administration.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.688
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Secondary Outcome Measures Will Include Change From Baseline in Verbal Reports of Anxiety 6 Hours After Drug/Placebo Administration
Hide Description 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
Time Frame 6 hours post drug or placebo administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxytocin Saline as a Nasal Spray
Hide Arm/Group Description:

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. 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.

Saline, 4ml intranasally, once

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.

Overall Number of Participants Analyzed 25 25
Mean (Standard Error)
Unit of Measure: units on a scale
-1.2  (.4) -1.0  (.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oxytocin, Saline as a Nasal Spray
Comments [Not Specified]
Type of Statistical Test Other
Comments paired t-test comparison of change in VAR from baseline 6 hours after drug; a change in VAR score was calculated for each subject for each arm and compared using a paired t-test
Statistical Test of Hypothesis P-Value 0.7252
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame Adverse events were assessed for 24 hours after each drug/placebo administration
Adverse Event Reporting Description Patients did not report any adverse events
 
Arm/Group Title Oxytocin Saline as a Nasal Spray
Hide Arm/Group Description

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. 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.

Saline, 4ml intranasally, once

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.

All-Cause Mortality
Oxytocin Saline as a Nasal Spray
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Oxytocin Saline as a Nasal Spray
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Oxytocin Saline as a Nasal Spray
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 
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
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