Status:
COMPLETED
Effects of AFQ056 and Baclofen on Meal-Induced Gastroesophageal Reflux
Lead Sponsor:
Novartis
Conditions:
Gastroesophageal Reflux Disease
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
This study will assess the safety and tolerability of oral single dose applications of AFQ056 in GERD patients.
Eligibility Criteria
Inclusion
- 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:
- 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.
- 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.
- Patients must be able to completely finish the high-fat breakfast within 15 minutes.
- Body mass index must be below 30. Patients must weigh at least 60 kg to participate in this study.
- 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.
Exclusion
- History of:
- Upper gastrointestinal (GI) surgery or radiation
- 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
- Delayed gastric emptying, or endoscopic indications for a delay in gastric emptying or gastric outlet obstruction.
- Neurologic/psychiatric disorders including a family history of epilepsy clinically significant cardiac disease
- Diabetes mellitus or other metabolic disorders including hyperlipidemia requiring treatment
- Any significant acute or chronic conditions except for following treated by the quoted drugs with a stable therapy for at least 4 weeks:
- Hypertension well-controlled with the following:
- ACE inhibitors: benazepril, captopril, cilazapril, enalapril, fosinopril, imidapril, lisinopril, moexipril, perindopril tert-butylamine, quinapril, ramipril, spirapril, trandolapril, zofenopril, and/or
- angiotensin II receptor antagonists: candesartan cilexetil, eprosartan, irbesartan, losartan, olmesartan, telmisartan, valsartan, and/or
- diuretics: amiloride, bendroflumethiazide, bumetanide, canrenoate de potassium, chlortalidone, cicletanine, clopamide, cyclothiazide, furosemide, hydrochlorothiazide, indapamide, methyclothiazide, piretanide, spironolactone, torasemide, triamterene, xipamide, and/or
- calcium antagonists: bepridil, felodipine, isradipine, lercanidipine, manidipine, nimodipine, nitrendipine, amlodipine, nicardipine BUT NOT diltiazem, nifedipine, verapamil
- Well-compensated asthma with topical use of corticosteroids and/or β2-mimetics
- Patients on thyroid hormone therapy with a normal TSH value.
- Nonsteroidal anti-inflammatory drugs including aspirin use in the week prior to treatment/impedance monitoring.
- Patients with body mass index ≥ 30.
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00414856
Start Date
August 1 2006
Last Update
June 22 2007
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigative site
Brussels, Belgium
2
Novartis Investigative site
Paris, France
3
Novartis Investigative Site
Nuremberg, Germany
4
Novartis Investigative site
Bern, Switzerland