Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:31 AM
Study NCT ID:
NCT00919802
Status:
COMPLETED
Last Update Posted:
2017-05-23
First Post:
2009-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Intranasal Oxytocin for the Treatment of Pain Associated With Interstitial Cystitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018856', 'term': 'Cystitis, Interstitial'}], 'ancestors': [{'id': 'D003556', 'term': 'Cystitis'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010121', 'term': 'Oxytocin'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tness@uabmc.edu', 'phone': '205-975-9643', 'title': 'Timothy Ness', 'organization': 'UAB'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were assessed for 24 hours after each drug/placebo administration', 'description': 'Patients did not report any adverse events', 'eventGroups': [{'id': 'EG000', 'title': 'Oxytocin', 'description': 'Oxytocin, 40 IU intranasally, once\n\nOxytocin: 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.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Saline as a Nasal Spray', 'description': 'Saline, 4ml intranasally, once\n\nSaline 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.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline Measured as Global Response Assessment (GRA) Score at 6 and 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin', 'description': 'Oxytocin, 40 IU intranasally, once\n\nOxytocin: 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.'}, {'id': 'OG001', 'title': 'Saline as a Nasal Spray', 'description': 'Saline, 4ml intranasally, once\n\nSaline 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '.5', 'spread': '.2', 'groupId': 'OG000'}, {'value': '-.1', 'spread': '.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.688', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Global Response Assessment (GRA) scores were obtained 6 and 24 hours post oxytocin or saline administration.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '6 and 24 hours post drug or placebo administration - the data below reflects 6 hour data', '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', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Secondary Outcome Measures Will Include Change From Baseline in Verbal Reports of Anxiety 6 Hours After Drug/Placebo Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin', 'description': 'Oxytocin, 40 IU intranasally, once\n\nOxytocin: 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.'}, {'id': 'OG001', 'title': 'Saline as a Nasal Spray', 'description': 'Saline, 4ml intranasally, once\n\nSaline 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.2', 'spread': '.4', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7252', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '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'}], 'paramType': 'MEAN', 'timeFrame': '6 hours post drug or placebo administration', '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', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intranasal Oxytocin, Followed by Intranasal Saline', 'description': 'Oxytocin, 40 IU intranasally, once\n\nOxytocin: 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.'}, {'id': 'FG001', 'title': 'Intranasal Saline Followed With Intranasal Oxytocin', 'description': 'Saline, 4ml intranasally, once\n\nPatients will be randomized to receive saline as a nasal spray: A single dose of saline will be dispensed in a random fashion to subjects.\n\nPatients 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.'}], 'periods': [{'title': 'First Intervention - (24 Hours)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention - (24 Hours)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Protocol Open to Accrual: June 2010, Primary Completion Date: September 2015 and Study Completion Date: September 2015. Recruitment location: University of Alabama at Birmingham.', 'preAssignmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', '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.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-23', 'studyFirstSubmitDate': '2009-06-09', 'resultsFirstSubmitDate': '2016-12-27', 'studyFirstSubmitQcDate': '2009-06-11', 'lastUpdatePostDateStruct': {'date': '2017-05-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-23', 'studyFirstPostDateStruct': {'date': '2009-06-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline Measured as Global Response Assessment (GRA) Score at 6 and 24 Hours', 'timeFrame': '6 and 24 hours post drug or placebo administration - the data below reflects 6 hour data', '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'}], 'secondaryOutcomes': [{'measure': 'Secondary Outcome Measures Will Include Change From Baseline in Verbal Reports of Anxiety 6 Hours After Drug/Placebo Administration', 'timeFrame': '6 hours post drug or placebo administration', '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'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Interstitial cystitis (IC)', 'Oxytocin', 'Bladder', 'Void'], 'conditions': ['Interstitial Cystitis']}, 'descriptionModule': {'briefSummary': 'Anecdotal evidence suggests female patients with painful bladder disorder interstitial cystitis (IC) can experience a significant attenuation of their systems while breastfeeding. Since it has been shown that postpartum lactation is a time associated with decreased levels of stress, and stress has been shown to exacerbate IC-related pain, the investigators have developed an interest in the effects of the hormones involved in postpartum lactation on stress and pain. Based on a series of pre-clinical experiments, the investigators believe the hormone oxytoxin has both analgesic and anxiolytic properties which make it a potentially useful agent for the treatment of stress-exacerbated chronic pain syndrome such as IC. Therefore, the investigators propose a double-blinded, placebo-controlled crossover trial of intranasal oxytocin vs. intranasal saline for bladder pain in a cohort of patients with IC and some degree of continuous, daily pain.', 'detailedDescription': "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.\n\nThe 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.\n\nIf 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 19 - 65 years of age\n* 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\n\nExclusion Criteria:\n\n* Pregnancy\n* Under the age of 19\n* Older that the age of 65\n* Breastfeeding women\n* Uncontrolled hypertension\n* History of significant cardiac or pulmonary disease (including arrhythmias)\n* Known allergy to oxytocin\n* Severe psychiatric disease\n* Patients who have undergone procedural interventions within the past month related to their interstitial cystitis'}, 'identificationModule': {'nctId': 'NCT00919802', 'briefTitle': 'Intranasal Oxytocin for the Treatment of Pain Associated With Interstitial Cystitis', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Intranasal Oxytocin for the Treatment of Pain Associated With Interstitial Cystitis', 'orgStudyIdInfo': {'id': 'UAB0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Oxytocin', 'description': 'Oxytocin, 40 IU intranasally, once', 'interventionNames': ['Drug: Oxytocin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline as a nasal spray', 'description': 'Saline, 4ml intranasally, once', 'interventionNames': ['Other: Saline as a nasal spray']}], 'interventions': [{'name': 'Oxytocin', 'type': 'DRUG', 'otherNames': ['Syntocinon'], 'description': '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.', 'armGroupLabels': ['Oxytocin']}, {'name': 'Saline as a nasal spray', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Saline as a nasal spray']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Meredith T Robbins, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'De-identified raw data will be made available on request by contacting contact investigator at tness@uabmc.edu'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Tim Ness, MD', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}