Treatment of abdominal symptoms in patients with functional dyspepsia
Conditions
Interventions
Product Name: Itax
Product Code: HSR-803
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Itopride Hydrochloride
CAS Number: 1228
Sponsors
AXCAN PHARMA Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male and female outpatients. - 18-65 years old. - Patients need to 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. 3. No evidence that dyspepsia is exclusively relieved by defecation or associated with the onset of a change in stool frequency or stool form (not IBS). - All patients enrolled must have had negative upper GI endoscopies to exclude organic disease, such as esophagitis, gastric or duodenal ulcer, esophageal or gastric neoplasia, within 1 month prior to enrolment. At the time of the endoscopy, patients must have been off Proton Pump Inhibitors (PPIs) and H2-receptor antagonists for at least 14 days. - Patients in whom heartburn (i.e. burning, retrosternal pain) is infrequent, not exceeding a frequency of one episode per week, and is subordinate to their abdominal pain or discomfort. - Evidence of H. pylori negative status, as confirmed by either C-13 within 7 days prior to enrolment or with biopsy at endoscopy. - Signed informed consent at screening visit. - Patient is on a stable diet and will remain on it for the duration of the study. - Baseline severity of at least moderate on the LDQ (total score of 9 and above). 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: - Patients suffering mainly or exclusively from symptoms corresponding to reflux disease. - Patients suffering from regurgitation and/or vomiting. - Abnormal upper GI endoscopy findings, e.g., esophageal, gastric erosions, ulcers. - Patients for whom the symptoms are exclusively relieved by defecation or associated with the onset of a change in stool frequency or stool form (not irritable bowel syndrome). - 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 = 4.0 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). - Smoker who has significantly changed his/her smoking habits within 14 days prior to administration of study medication, or non-smoker who has become a smoker within 14 days prior to administration of study medication. - Pregnancy or lactation. - Women with childbearing potential who do not apply a medically accepted method of contraception (e.g., hysterectomy, sterilization, oral contraception). - Known alcoholism or drug abuse. - Participation in another clinical trial within one month prior to enrolment or during the course of the study. - Celiac disease or enteropathy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish the efficacy of itopride HCl 100 mg tid compared with placebo in improving the symptoms of functional dyspepsia after 8 weeks of treatment. Efficacy will be measured using an adapted version of the LDQ (Leeds Dyspepsia Questionnaire), which will monitor the change in the overall severity of functional dyspepsia during the treatment phase. The LDQ questions assessing the symptoms of upper abdominal pain and fullness will be used as the primary outcome measure, along with the 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”. ; Secondary Objective: Comparisons between itopride HCl and placebo for the following secondary efficacy variables: - Change from baseline in the overall severity of FD as measured at week 4 and 8 using the Leeds Dyspepsia Questionnaire (LDQ) severity score. - Change in the patients’ quality of life as measured by the Nepean Dyspepsia Index (NDI) at weeks 0, 2, 4 and 8. - Change in the overall severity of functional dyspepsia as measured by the NDI symptom score at weeks 0, 2, 4 and 8. - Change in the Global Patient Assessment of Efficacy at week 2 and 4. SAFETY OBJECTIVES - To establish the safety profile of itopride HCl as measured by adverse events reporting, vital parameters and performance of safety lab tests. - To establish cardiac safety by repeated 12 lead ECG, at baseline, week 2 and week 8 visits. As well, a subset of 30 patients will be monitored more closely for cardiac safety through 24-hour Holter monitoring. ; Primary end poin | — |
Countries
Germany, United Kingdom
Outcome results
None listed