Trial Outcomes & Findings for Intranasal Oxytocin for the Treatment of Pain Associated With Interstitial Cystitis (NCT NCT00919802)
NCT ID: NCT00919802
Last Updated: 2017-05-23
Results Overview
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
COMPLETED
PHASE4
25 participants
6 and 24 hours post drug or placebo administration - the data below reflects 6 hour data
2017-05-23
Participant Flow
Protocol Open to Accrual: June 2010, Primary Completion Date: September 2015 and Study Completion Date: September 2015. Recruitment location: University of Alabama at Birmingham.
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.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
First Intervention - (24 Hours)
STARTED
|
12
|
13
|
|
First Intervention - (24 Hours)
COMPLETED
|
12
|
13
|
|
First Intervention - (24 Hours)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention - (24 Hours)
STARTED
|
12
|
13
|
|
Second Intervention - (24 Hours)
COMPLETED
|
12
|
13
|
|
Second Intervention - (24 Hours)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intranasal Oxytocin for the Treatment of Pain Associated With Interstitial Cystitis
Baseline characteristics by cohort
| Measure |
All Study Participants
n=25 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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 and 24 hours post drug or placebo administration - the data below reflects 6 hour dataThis 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
Outcome measures
| Measure |
Oxytocin
n=25 Participants
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 as a Nasal Spray
n=25 Participants
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.
|
|---|---|---|
|
Change From Baseline Measured as Global Response Assessment (GRA) Score at 6 and 24 Hours
|
.5 units on a scale
Standard Error .2
|
-.1 units on a scale
Standard Error .2
|
SECONDARY outcome
Timeframe: 6 hours post drug or placebo administrationA 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
Outcome measures
| Measure |
Oxytocin
n=25 Participants
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 as a Nasal Spray
n=25 Participants
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.
|
|---|---|---|
|
Secondary Outcome Measures Will Include Change From Baseline in Verbal Reports of Anxiety 6 Hours After Drug/Placebo Administration
|
-1.2 units on a scale
Standard Error .4
|
-1.0 units on a scale
Standard Error .4
|
Adverse Events
Oxytocin
Saline as a Nasal Spray
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place