Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:50 PM
Study NCT ID:
NCT00414856
Status:
COMPLETED
Last Update Posted:
2007-06-22
First Post:
2006-12-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of AFQ056 and Baclofen on Meal-Induced Gastroesophageal Reflux
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C581397', 'term': 'mavoglurant'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-06', 'lastUpdateSubmitDate': '2007-06-21', 'studyFirstSubmitDate': '2006-12-21', 'studyFirstSubmitQcDate': '2006-12-21', 'lastUpdatePostDateStruct': {'date': '2007-06-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-12-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gastroesophageal reflux episodes as assessed by impedance measurements in the 4-hour period following a standardized high-fat meal in patients with GERD.'}], 'secondaryOutcomes': [{'measure': 'Safety and tolerability of oral AFQ056 in GERD patients.'}, {'measure': 'Pharmacokinetics (PK) of two AFQ056 single oral doses in patients with GERD.'}, {'measure': 'Relationships between AFQ056 blood levels and/or how the body interacts with the medication and overall reflux incidence'}, {'measure': 'Validation of the reflux model used in this study using baclofen as positive control.'}, {'measure': 'Effects of AFQ056 on other impedance/pH parameters, including but not limited to the rate of reflux episodes at various time intervals'}]}, 'conditionsModule': {'keywords': ['GERD', 'gastroesophageal reflux disease', 'meal-induced gastroesophageal reflux events'], 'conditions': ['Gastroesophageal Reflux Disease']}, 'descriptionModule': {'briefSummary': 'This study will assess the safety and tolerability of oral single dose applications of AFQ056 in GERD patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male and female patients with GERD (18-60 years) with a history of moderate to severe reflux symptoms (heartburn or acid regurgitation more than 2 days/week, and/or night-time reflux, and/or after meal reflux) for ≥ 3 months with:\n\n * uncomplicated reflux-esophagitis of any degree as evidenced by esophagogastroduodenoscopy (EGD) within the last 12 months, OR (and) a pathological ambulatory 24-hours pH measurement within the last 12 months with pH \\< 4 for ≥ 9% of the time.\n* Females must be of no child bearing potential (postmenopausal women with no regular menstrual bleeding for at least 1 year or women who have been surgically sterilized at least 6 months prior). Menopause will be confirmed by a plasma FSH level of 37.0 - 185.0 mIU/mL. Surgical sterilization procedures must be supported with clinical documentation.\n* Patients must be able to completely finish the high-fat breakfast within 15 minutes.\n* Body mass index must be below 30. Patients must weigh at least 60 kg to participate in this study.\n* Patients must be able to communicate well with the investigator, to understand and comply with the requirements of the study and to understand and sign the written informed consent.\n\nExclusion Criteria:\n\nHistory of:\n\n* Upper gastrointestinal (GI) surgery or radiation\n* GI disorders other than GERD that may significantly affect the incidence and/or assessment of reflux episodes (GI motility disorders, connective tissue disease like scleroderma, Barrett's esophagus, hiatal hernia \\> 3-4 cm, previous esophageal bleeding, esophageal varices, active gastric or duodenal ulcer disease, active esophagitis\n* Delayed gastric emptying, or endoscopic indications for a delay in gastric emptying or gastric outlet obstruction.\n* Neurologic/psychiatric disorders including a family history of epilepsy clinically significant cardiac disease\n* Diabetes mellitus or other metabolic disorders including hyperlipidemia requiring treatment\n* Any significant acute or chronic conditions except for following treated by the quoted drugs with a stable therapy for at least 4 weeks:\n\n * Hypertension well-controlled with the following:\n\n 1. ACE inhibitors: benazepril, captopril, cilazapril, enalapril, fosinopril, imidapril, lisinopril, moexipril, perindopril tert-butylamine, quinapril, ramipril, spirapril, trandolapril, zofenopril, and/or\n 2. angiotensin II receptor antagonists: candesartan cilexetil, eprosartan, irbesartan, losartan, olmesartan, telmisartan, valsartan, and/or\n 3. diuretics: amiloride, bendroflumethiazide, bumetanide, canrenoate de potassium, chlortalidone, cicletanine, clopamide, cyclothiazide, furosemide, hydrochlorothiazide, indapamide, methyclothiazide, piretanide, spironolactone, torasemide, triamterene, xipamide, and/or\n 4. calcium antagonists: bepridil, felodipine, isradipine, lercanidipine, manidipine, nimodipine, nitrendipine, amlodipine, nicardipine BUT NOT diltiazem, nifedipine, verapamil\n * Well-compensated asthma with topical use of corticosteroids and/or β2-mimetics\n * Patients on thyroid hormone therapy with a normal TSH value.\n* Nonsteroidal anti-inflammatory drugs including aspirin use in the week prior to treatment/impedance monitoring.\n* Patients with body mass index ≥ 30.\n\nOther protocol-defined inclusion/exclusion criteria may apply"}, 'identificationModule': {'nctId': 'NCT00414856', 'briefTitle': 'Effects of AFQ056 and Baclofen on Meal-Induced Gastroesophageal Reflux', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Multi-Center, Randomized, Double-Blind, Placebo- and Positive-Control, Double-Dummy, 3 Parallel Cohort, Two-Way Crossover Single Oral Dose Study in GERD (Gastro Esophageal Reflux Disease) Patients to Evaluate the Effects of AFQ056 and Baclofen (Positive Control) on the Incidence of Meal-Induced Gastro Esophageal Reflux Events', 'orgStudyIdInfo': {'id': 'CAFQ056A2108'}}, 'armsInterventionsModule': {'interventions': [{'name': 'AFQ056', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brussels', 'country': 'Belgium', 'facility': 'Novartis Investigative site', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Paris', 'country': 'France', 'facility': 'Novartis Investigative site', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Nuremberg', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.45421, 'lon': 11.07752}}, {'city': 'Bern', 'country': 'Switzerland', 'facility': 'Novartis Investigative site', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Novartis', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Investigator site'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}}}}