A multicenter, double-blind, randomized, placebo controlled phase III study of the efficacy and safety of Trimebutine 300 mg twice daily for the relief of functional dyspeptic patients

• Registration Number: EUCTR2008-001886-26-GR
• Lead Sponsor: GALENICA S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-10
• Last Update Posted: 12 May 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

A subject is eligible for inclusion in this study only if all of the following criteria apply:
1.Ambulant male and non pregnant female subjects.
2.Age between 18 and 75 years old (including the limits) at the randomisation visit.
3.History of epigastric pain or discomfort at least 1 of the last 7 days before randomisation.
4.Normal macroscopic findings from oesophagus, stomach and duodenum during the endoscopy which will take place 10 days (±4 days) prior to enrolment.
5.Willing and able to sign the informed consent prior to entry into the study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects will not be eligible for inclusion in this study if any of the following conditions apply:
1.Alarm symptoms (loss of weight, vomit, hematemesis, melaena, fever, icterus or any other sign which indicates serious or virulent disease).
2.Irritable Bowel Syndrome (IBS) as it was defined by Rome Criteria II (1999); abdominal pain for at least 12 weeks (not necessarily sequential) which has 2 or more of the below characteristics:
?Relieved with evacuation.
?Change at the frequency of the evacuations.
?Constitution of excrements.
3.Chronic serious constipation.
4.Patients with retrosternal burning pain.
5.History of serious or uncontrolled diseases.
6.History of peptic ulcer (endoscopy or radiogram) or gastroesophagical reflux disease (endoscopy), gastritis or other significant gastrointestinal disease.
7.History of peptic or other abdominal surgery (appendectomy and gynaecological surgeries excluded).
8.Patients with history of gallbladder surgery.
9.Pregnancy (examined with blood test) or breastfeeding.
10. Participation in a clinical trial within the previous month or current participation in any other clinical research study or clinical trial.
11.Abnormal physical, haematology and biochemistry examinations prior to enrolment (according to the investigator’s decision).
12.Use of non steroid antiflammatory drugs (during the study).
13.Usage of drugs that from the investigators point of view could cause dyspeptic symptoms.
14.Alcoholism or psychic disease which could lead to non compliance with the investigator’s instructions.
15. Known Hypersensitivity to drastic substance.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified