A clinical study to evaluate the efficacy and safety of acotiamide in indian adult patients with functional dyspepsia-post prandial distress syndrome

Phase 3

Conditions: Health Condition 1: K30- Functional dyspepsiaHealth Condition 2: K30- Functional dyspepsia

Registration Number: CTRI/2016/03/006763

Lead Sponsor: Hetero Labs Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 220

Inclusion Criteria

• The patient is willing to give written, signed, and dated informed consent to participate in the study before initiating any study related procedures

• Patients with Functional Dyspepsia-Post Prandial distress syndrome (FD-PDS) as defined by the Rome III classification â??(Postprandial fullness or early satiation for at least 6 months or two or more of the following symptoms at a moderate or severe level within the previous 3 months: upper abdominal pain, upper abdominal discomfort, postprandial fullness, upper abdominal bloating, early satiation, nausea, vomiting or excessive belching.)â??

• Patients experienced two or more of the following symptoms at a moderate or severe level for 2 days or longer during the baseline period: postprandial fullness, upper abdominal bloating, or early satiety.

• If patients have coexisting epigastric pain syndrome symptoms (epigastric pain, epigastric burning), but the symptom causing the most distress at the time of obtaining informed consent had to be one of the following meal-related symptoms: postprandial fullness, upper abdominal bloating or early satiation.

• Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from screening throughout the duration of the study

• Clinical laboratory evaluations (including clinical chemistry, hematology, and complete urinalysis) within the reference range for the testing laboratory or the results are deemed not clinically significant for inclusion into this study by the investigator

Exclusion Criteria

• Patients with structural disease that is likely to explain the symptom (GERD, erosion, ulcer, hiatal hernia, bleeding, malignancy or Barretts esophagus)

• Patients have heartburn in last 12 weeks before obtaining informed consent and during the baseline period

• Patients with irritable bowel disease (IBS)

• Patients with diabetes mellitus requiring treatment

• Patients with serious anxiety disorder

• Patients with depression and/or sleep disorder

• Patients with biliary tract disease and/or pancreatitis (including chronic pancreatitis)

• Patients with presence of any symptom indicating serious or malignant disease

• Abnormality in the electrocardiogram at rest

• Hypersensitive to any of the investigational product or its components

• Currently have a clinically significant neurological, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal and/or urological disorder

• History of drug or alcohol abuse

• Currently participating in another investigational study or has participated in an investigational study within 90 days prior to randomization

• Patients with the current/past infections such as tuberculosis, herpes and/or patients with immune system disorders like HIV and SLE

• Any other disease state which could interfere with trial participation or trial evaluation as per investigatorâ??s discretion

• Women of child-bearing potential, pregnant or lactating women, women practicing contraception by other than barrier methods or intending to donate eggs within the projected duration of the study and post-study follow-up period

• The physician is of the opinion that patientâ??s trial medications would put the patient at risk

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Responder rates for Overall treatment effect (OTE) by using 7-point Likert scaleTimepoint: Baseline to Week 4 or End of treatment

Secondary Outcome Measures

Name	Time	Method
Assessment of the effects of treatment on disease-specific QoL by using Short Form-Nepean Dyspepsia Index questionnaire (SF-NDI)Timepoint: Baseline to Week 4 or End of treatment;Elimination rate of post-prandial fullness, upper abdominal bloating and early satietyTimepoint: Baseline to last reporting time point;Overall treatment effect (OTE) by using 7-point Likert scaleTimepoint: Baseline to Weekly;The improvement of individual symptom (upper abdominal pain, upper abdominal discomfort, postprandial fullness, upper abdominal bloating, early satiation, excessive belching, nausea, vomiting and heartburn) score on a severity scale of 0-3 (none, mild, moderate and severe)Timepoint: Baseline to Weekly;Treatment emergent clinical & laboratory adverse events (TEAEs)Timepoint: All time points