Treatment of abdominal symptoms in patients with functional dyspepsia
Conditions
Interventions
Product Name: Itopride 100 mg (itopride HCl 110 mg) tablets
Product Code: HSR-803
Pharmaceutical Form: Coated tablet
CAS Number: 122892-31-3
Current Sponsor code: HSR-803(Laboratory use)
Other descri
Sponsors
AXCAN PHARMA Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For patients having completed ITOFD04-03 (double-blind study) (EudraCT number: 2004-000448-26) the inclusion criteria are as follows: -Patients must have completed the 8 week double-blind period; -Female patients must not be pregnant (must have a negative serum pregnancy test); -Patients must sign an Informed Consent Form, which must comply with EMEA regulations, US, Canadian or ICH guidelines and local requirements. For patients not having been randomized to the double-blind study (ITOFD04-03) the inclusion criteria are as follows: -Male and female outpatients; -18-65 years old; -Meet the following Rome II criteria: (1) Presence of persistent or recurrent dyspepsia (pain or discomfort centered in the upper abdomen). Discomfort may be characterized by or associated with upper abdominal fullness, early satiety, bloating, or nausea. (2) No evidence of organic disease that is likely to explain the symptoms; -Known H. pylori status (can be positive or negative), as confirmed by C-13 within 7 days prior to enrolment; -Signed informed consent at screening visit. 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: For patients having completed ITOFD04-03 (double-blind study) the exclusion criteria are as follows: -Patients with extrapyramidal symptoms; -Patients with any newly occurring medical condition which was an exclusion criterion at ITOFD04-03 study entry. See below for a list of this exclusion criteria. For patients not having been randomized to the double-blind study (ITOFD04-03) the exclusion criteria are as follows: -No organic disease, such as esophagitis, gastric or duodenal ulcer, esophageal or gastric neoplasia, as confirmed by either an upper endoscopy during the past 6 months, or with a barium meal, conducted at the time of the screening visit; -Patients suffering mainly or exclusively from symptoms corresponding to reflux disease; -Clinical evidence or diagnosis of gallbladder or biliary tract disease, pancreatic disease confirmed by upper abdominal ultrasound; -Clinical evidence or diagnosis of chronic inflammatory bowel disease; -Patients with clinically relevant ECG abnormalities such as a QRS duration > 110 msec, heart rate 470 msec on the screening ECG; -Patients with known arrhythmias, such as: chronic/paroxysmal atrial fibrillation, supraventricular tachycardia, ventricular tachycardia or “torsades de pointe”. -Active psychiatric disorder that would interfere with the study objectives; -Health conditions (e.g. age related impairment of cognitive functions) that would interfere with the study objectives or might impair the compliance of the patient. -Severe hepatic, renal, cardiac, metabolic, hematological or malignant diseases (including prolactin dependent tumors) or clinically relevant deviations in laboratory values (AST/ALT) greater than twice the upper limit of normal, serum creatinine > 2 mg/dL, hyperthyroid or hypothyroid patient according to the medical judgment of the investigator. Patients with hypokalemia (serum potassium < or = 3.5 mmol/L) and hypomagnesemia (serum magnesium < 1.7 mg/dL); -History of any known hypersensitivity to the ingredients of the investigational drug; -Patients with a genetic disease called trimethylaminuria (fish odor syndrome). -Patients with laxative abuse, as judged by the investigator; -Patients with any known specific food intolerance (whose symptoms disappear completely and persistently if he/she does not eat the particular food, e.g., lactose intolerance); -Pregnancy or lactation; -Women with childbearing potential who do not use a medically accepted method of contraception (e.g., hysterectomy, sterilization, oral contraception); -Known alcoholism or drug abuse; -Participation in a clinical trial (other than ITOFD04-03) within one month prior to enrolment or during the course of the study; -Celiac disease or enteropathy; -Patients with extrapyramidal symptoms.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety profile of itopride 100 mg (itopride HCl 110 mg) tid when given long-term, testing the following variables every 8 weeks for a period of up to 52 weeks: - Laboratory testing - Adverse Events - Compliance Cardiac function (12-lead ECG) will be tested at baseline, week 24 and 52. ;Secondary Objective: To evaluate the therapeutic benefit over long-term by measuring: - Global patient assessment of efficacy utilizing the response to a single question: “Please rate the strength of your upper abdominal complaints in the past 14 days. Compared to the condition at the outset of treatment, how much have they changed? Please mark the statement that best applies to you: symptom-free, markedly improved, slightly improved, unchanged, worse”. This efficacy variable will be measured every 8 weeks for a period of up to 52 weeks. ;Primary end point(s): Safety Endpoints: -General safety profile of itopride HCl as measured by adverse events reporting and performance of safety lab tests every 8 weeks; -Cardiac safety measured by repeated 12 lead ECGs, at month 0, 6 and 12; -Physical exam and vital parameters at month 0, 6 and 12. | — |
Countries
Belgium, Germany
Outcome results
None listed