Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-25 @ 9:01 PM
Study NCT ID:
NCT01331356
Status:
COMPLETED
Last Update Posted:
2013-10-07
First Post:
2011-03-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Analgesic Effect of an Injection of Botulinum Toxin Type A in the Ganglion Impar in Patients With Chronic Proctalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060545', 'term': 'Pudendal Neuralgia'}], 'ancestors': [{'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}], 'ancestors': [{'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-04', 'studyFirstSubmitDate': '2011-03-31', 'studyFirstSubmitQcDate': '2011-04-06', 'lastUpdatePostDateStruct': {'date': '2013-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in main score (SP) at 1 month', 'timeFrame': 'one month', 'description': 'The main objective is to evaluate the analgesic efficacy of botulinum toxin type A in refractory chronic proctalgia one month after a bilateral injection of 50 units of Botox ® in the ganglion Impar (total dose = 100 units) by calculating the main score (SP).'}], 'secondaryOutcomes': [{'measure': 'To assess the adverse events', 'timeFrame': '6 month'}, {'measure': 'To assess the duration of action of the product (main score SP)', 'timeFrame': '6 month'}, {'measure': 'To assess the changing parameters of quality of life: global improvement score / treatment satisfaction assessed by digital scale, international pain scales (MPI, QDSA, QCD) / Beck score and Hospital Anxiety and Depression (HAD) score', 'timeFrame': '6 month'}, {'measure': 'To assess the evolution of analgesics consumption', 'timeFrame': '6 month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chronic proctalgia', 'Botulinum toxin type A', 'Ganglion Impar', 'Perineal pain', 'Pudendal neuralgia', 'Refractory chronic proctalgia'], 'conditions': ['Proctalgia']}, 'descriptionModule': {'briefSummary': 'The main objective is to evaluate the analgesic efficacy of botulinum toxin type A in refractory chronic proctalgia one month after a bilateral injection of 50 units of Botox ® in the ganglion Impar (total dose = 100 units)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Patient with chronic proctalgia according to the criteria of Rome III\n* Chronic or recurrent rectal pain\n* Pains evolve over periods of at least 20 minutes\n* With the exclusion of other causes of rectal pain: ischemic, inflammatory bowel disease, cryptic lesions, intramuscular abscess, anal fissure, hemorrhoids, prostatitis and isolated coccydynia\n* Pains evolve in a regular way since more than 3 months and the symptoms started since at least 6 months\n* These chronic proctalgia include syndromes of anus elevator and nonspecific functional anorectal pains\n* Patient with positive anesthetic block of ganglion Impar (minimum of 30 days before D0 and maximum of 270 days before D0)\n* Main score (SP) ≥ 4 before infiltration of botulinum toxin type A\n* Signed informed consent\n* Subjects affiliated with an appropriate social security system\n\nExclusion Criteria:\n\n* Pain related malignancy\n* Patients with bleeding risk and recent anticoagulant therapy\n* Surgery within 3 months\n* Pre-existing anal incontinence\n* Intolerance of botulinum toxin A, local anesthetics and radio contrast medium\n* Injection of botulinum toxin in any place whatsoever in the previous 3 months\n* Pregnancy and breast feeding\n* Antibiotic treatment by aminoglycosides\n* Recent anti-inflammatory treatment\n* Severe myasthenia\n* Lambert-Eaton syndrome\n* Patients with neurological disorders, dysphagia, food choking or inhalation pneumonia'}, 'identificationModule': {'nctId': 'NCT01331356', 'acronym': 'Impartox', 'briefTitle': 'Analgesic Effect of an Injection of Botulinum Toxin Type A in the Ganglion Impar in Patients With Chronic Proctalgia', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Prospective Multicenter Pilot Study Evaluating the Analgesic Effect of an Injection of Botulinum Toxin Type A in the Ganglion Impar in Patients With Chronic Proctalgia According to the Criteria of Rome III', 'orgStudyIdInfo': {'id': '10/4-T'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Injection of botulinum toxin type A', 'interventionNames': ['Drug: Botox']}], 'interventions': [{'name': 'Botox', 'type': 'DRUG', 'description': 'One injection of botulinum toxin type A in the ganglion Impar in patients with chronic proctalgia', 'armGroupLabels': ['Injection of botulinum toxin type A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'Nantes University Hospital', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '44200', 'city': 'Nantes', 'country': 'France', 'facility': 'Centre Catherine de Sienne', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}], 'overallOfficials': [{'name': 'Jean-Jacques LABAT, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nantes University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}