Effects of AFQ056 and Baclofen on Meal-Induced Gastroesophageal Reflux

June 21, 2007 updated by: Novartis

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

34

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • Novartis Investigative Site
  • France
      • Paris, France
        • Novartis Investigative Site
  • Germany
      • Nuernberg, Germany
        • Novartis Investigative Site
  • Switzerland
      • Bern, Switzerland
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Study Registration Dates

First Submitted

December 21, 2006

First Submitted That Met QC Criteria

December 21, 2006

First Posted (Estimate)

December 22, 2006

Study Record Updates

Last Update Posted (Estimate)

June 22, 2007

Last Update Submitted That Met QC Criteria

June 21, 2007

Last Verified

June 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAFQ056A2108

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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