Effects of AFQ056 and Baclofen on Meal-Induced Gastroesophageal Reflux

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00414856
First received: December 21, 2006
Last updated: June 21, 2007
Last verified: June 2007
  Purpose

This study will assess the safety and tolerability of oral single dose applications of AFQ056 in GERD patients.


Condition Intervention Phase
Gastroesophageal Reflux Disease
Drug: AFQ056
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Gastroesophageal reflux episodes as assessed by impedance measurements in the 4-hour period following a standardized high-fat meal in patients with GERD.

Secondary Outcome Measures:
  • Safety and tolerability of oral AFQ056 in GERD patients.
  • Pharmacokinetics (PK) of two AFQ056 single oral doses in patients with GERD.
  • Relationships between AFQ056 blood levels and/or how the body interacts with the medication and overall reflux incidence
  • Validation of the reflux model used in this study using baclofen as positive control.
  • Effects of AFQ056 on other impedance/pH parameters, including but not limited to the rate of reflux episodes at various time intervals

Estimated Enrollment: 34
Study Start Date: August 2006
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

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:

      1. ACE inhibitors: benazepril, captopril, cilazapril, enalapril, fosinopril, imidapril, lisinopril, moexipril, perindopril tert-butylamine, quinapril, ramipril, spirapril, trandolapril, zofenopril, and/or
      2. angiotensin II receptor antagonists: candesartan cilexetil, eprosartan, irbesartan, losartan, olmesartan, telmisartan, valsartan, and/or
      3. diuretics: amiloride, bendroflumethiazide, bumetanide, canrenoate de potassium, chlortalidone, cicletanine, clopamide, cyclothiazide, furosemide, hydrochlorothiazide, indapamide, methyclothiazide, piretanide, spironolactone, torasemide, triamterene, xipamide, and/or
      4. 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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00414856

Locations
Belgium
Novartis Investigative site
Brussels, Belgium
France
Novartis Investigative site
Paris, France
Germany
Novartis Investigative Site
Nuernberg, Germany
Switzerland
Novartis Investigative site
Bern, Switzerland
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Novartis Investigator site
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00414856     History of Changes
Other Study ID Numbers: CAFQ056A2108
Study First Received: December 21, 2006
Last Updated: June 21, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
GERD
gastroesophageal reflux disease
meal-induced gastroesophageal reflux events

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Baclofen
GABA-B Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Muscle Relaxants, Central
Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014