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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-001886-26-GR

Enrollment

240

Registered

2009-11-10

Start date

2010-06-29

Completion date

Unknown

Last updated

2014-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Trade Name: Ibutine Product Name: Trimebutine Pharmaceutical Form: Modified-release tablet INN or Proposed INN: Trimebutine Concentration unit: mg milligram(s) Concentration type: equal Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to evaluate whether the patients are going to be relieved of the functional dyspepsia symptoms after being treated with Trimebutine 600 mg.;Secondary Objective: The secondary objectives of this study are to evaluate, in the same target population, the difference between the percentages of subjects who had no longer symptoms of functional dyspepsia after being treated with Trimebutine 600 mg or placebo 600 mg.;Primary end point(s): The primary endpoint is the relief of dyspeptic symptoms expressed for either treatment. This variable must be available for the patient to be included into this analysis. Any subject that lost follow –up will not be replaced. The analysis will test, separately in each sub-group, the reported relief from dyspeptic symptoms graded with GDSS. The test will be performed with the one-sample t-test vs. a constant. A secondary analysis will test whether the outcome measure is different in size between subgroups. This will be done by ANOVA, using as primary response variable the outcome measure, as explanatory factor the treatment, and as adjusting factor the country. If the country effect is not significant, no country adjustment will be applied to any subsequent analysis. If the treatment effect is not significant, all subsequent analyses shall be performed on the pooled measures (all assessable patients). This will have no inferential value and will only be descriptively used to estimate a possible treatment effect.	—

Measure

Time frame

Main Objective: The primary objective of this study is to evaluate whether the patients are going to be relieved of the functional dyspepsia symptoms after being treated with Trimebutine 600 mg.;Secondary Objective: The secondary objectives of this study are to evaluate, in the same target population, the difference between the percentages of subjects who had no longer symptoms of functional dyspepsia after being treated with Trimebutine 600 mg or placebo 600 mg.;Primary end point(s): The primary endpoint is the relief of dyspeptic symptoms expressed for either treatment. This variable must be available for the patient to be included into this analysis. Any subject that lost follow –up will not be replaced. The analysis will test, separately in each sub-group, the reported relief from dyspeptic symptoms graded with GDSS. The test will be performed with the one-sample t-test vs. a constant. A secondary analysis will test whether the outcome measure is different in size between subgroups. This will be done by ANOVA, using as primary response variable the outcome measure, as explanatory factor the treatment, and as adjusting factor the country. If the country effect is not significant, no country adjustment will be applied to any subsequent analysis. If the treatment effect is not significant, all subsequent analyses shall be performed on the pooled measures (all assessable patients). This will have no inferential value and will only be descriptively used to estimate a possible treatment effect.

—

Countries

Greece

Outcome results