E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment of abdominal symptoms in patients with functional dyspepsia |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the safety profile of itopride HCl 100 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.
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E.2.2 | Secondary objectives of the trial |
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.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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.
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E.4 | Principal exclusion criteria |
For patients having completed ITOFD04-03 (double-blind study) the exclusion criteria are as follows: -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 < 50 beats per minute or a QTc duration of > 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); -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;
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E.5 End points |
E.5.1 | 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.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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For this protocol, the visit of the last subject undergoing the trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |