Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-01-07 @ 3:27 PM
Study NCT ID:
NCT00857467
Status:
COMPLETED
Last Update Posted:
2009-12-23
First Post:
2009-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Investigate Safety and Response to 1 or 2 g Rectal Suppositories Containing 5 or 10 mg NRL001.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005242', 'term': 'Fecal Incontinence'}], 'ancestors': [{'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'lastUpdateSubmitDate': '2009-12-21', 'studyFirstSubmitDate': '2009-03-05', 'studyFirstSubmitQcDate': '2009-03-05', 'lastUpdatePostDateStruct': {'date': '2009-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in MARP after a single dose', 'timeFrame': '6 hours'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic plasma assessment to determine systemic uptake', 'timeFrame': '6 hours'}, {'measure': 'Adverse events', 'timeFrame': '6 hours'}, {'measure': 'Cardiovascular parameters; heart rate and blood pressure', 'timeFrame': '6 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Fecal Incontinence']}, 'referencesModule': {'references': [{'pmid': '24499492', 'type': 'DERIVED', 'citation': 'Simpson JA, Bush D, Gruss HJ, Jacobs A, Pediconi C, Scholefield JH. A randomised, controlled, crossover study to investigate the safety and response of 1R,2S-methoxamine hydrochloride (NRL001) on anal function in healthy volunteers. Colorectal Dis. 2014 Mar;16 Suppl 1:5-15. doi: 10.1111/codi.12541.'}]}, 'descriptionModule': {'briefSummary': 'This is a healthy volunteer three-way crossover study. A total of 12 subjects will receive three single administrations of 1 g rectal suppositories (containing either 5 mg NRL001, 10 mg NRL001 or matching placebo), with a washout period of at least 7 days between dosings. A further 12 subjects will receive three single administrations of 2 g rectal suppositories (containing either 5 mg NRL001, 10 mg NRL001 or matching placebo), again with a 7 day washout period between dosings. The pharmacodynamic response, pharmacokinetics and safety profile will be determined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. No previous history of ano-rectal conditions or diseases\n2. No history of cardiovascular disease\n3. 18 to 60 years of age\n4. Males and females (pre-menopausal females of child-bearing potential must be using adequate contraceptive methods and have a negative pregnancy test before the start of the study)\n\nExclusion Criteria:\n\n1. Use of medication in the last 30 days with a vasodilatory activity, or use of any medication currently or within the last 30 days which the Investigator believes may affect the study participation or results\n2. Use of monoamine oxidase inhibitors presently or within the last 2 weeks before study participation\n3. Use of any medication in the last 30 days applied to the anus and/or via the rectum\n4. Application of any unlicensed medication within the previous 3 months or participation in any other research study in the last three months which involved being paid a disturbance allowance; having an invasive procedure (e.g. venepuncture \\>50ml, endoscopy) or exposure to ionising radiation.\n5. Regular intake of more than 21 units of alcohol per week\n6. History or any evidence of cardiovascular disease including ischaemic heart disease and hypertension (defined on examination: systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 90 mmHg; based on at least two separate readings), peripheral vascular disease or Raynaud's syndrome\n7. Presence of diabetes mellitus\n8. History or symptoms of thyroid diseases, including hypo- or hyperthyroidism\n9. Pregnant or lactating females\n10. History of any clinically relevant allergy\n11. Presence of concomitant gastrointestinal diseases or disorders, such as significant abdominal symptoms and haemorrhoids but also any significant organ (e.g. renal, hepatic or cardiac) dysfunction\n12. Volunteers whom the Investigator feels would not comply with the requirements of the trial\n13. Volunteers who have been exposed to more than 5 mSv of ionising radiation in the last 12 months."}, 'identificationModule': {'nctId': 'NCT00857467', 'briefTitle': 'Study to Investigate Safety and Response to 1 or 2 g Rectal Suppositories Containing 5 or 10 mg NRL001.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Norgine'}, 'officialTitle': 'Randomised, Double-blind, Single Dose, Three-way, Cross-over Study to Investigate the Safety and Response to 1g or 2g Rectal Suppositories Containing 5 mg or 10 mg 1R,2S-methoxamine Hydrochloride [NRL001] or Matching Placebo', 'orgStudyIdInfo': {'id': 'NRL001-01/2008 (SUM)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1 g suppository', 'description': 'Subjects receive 5 mg NRL001, 10 mg NRL001 and placebo in a 1g rectal suppository', 'interventionNames': ['Drug: NRL001']}, {'type': 'EXPERIMENTAL', 'label': '2 g suppository', 'description': 'Subjects receive 5 mg NRL001, 10 mg NRL001 and placebo in a 2 g rectal suppository.', 'interventionNames': ['Drug: NRL001']}], 'interventions': [{'name': 'NRL001', 'type': 'DRUG', 'description': 'Subjects receive single doses of 5 mg NRL001, 10 mg NRL001 and placebo in a 1 g rectal suppository, with a 7-day washout period between dosing.', 'armGroupLabels': ['1 g suppository']}, {'name': 'NRL001', 'type': 'DRUG', 'description': 'Subjects receive single doses of 5 mg NRL001, 10 mg NRL001 and placebo in a 2 g rectal suppository, with a 7-day washout period between dosing.', 'armGroupLabels': ['2 g suppository']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NG7 2UH', 'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Department of GI Surgery, Nottingham University Hospital', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'overallOfficials': [{'name': 'Hans-Jürgen Gruss, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Norgine'}, {'name': 'John H Scholefield, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nottingham University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norgine', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Vice President Clinical Development', 'oldOrganization': 'Norgine'}}}}