A Randomized, Double Blind, Placebo Controlled, Parallel Group, Comparative Clinical Study to Evaluate the Efficacy and Safety of OLNP-06 versus Placebo in Subjects with Functional Dyspepsia.

Olene Life Sciences Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1. Male or female subjects age 18 - 55 years.
•2. Diagnosis of functional dyspepsia, Postprandial distress Syndrome by fulfilling Rome-III criteria
•3. Subjects with at least one of the following two for at least 6 months
•i)Post prandial fullness
•ii)Early satiety
•Subjects with two or more of the following symptoms at a moderate or severe level within the previous 03 months (At least one symptoms of postprandial fullness, upper abdominal bloating or early satiety should be included)
•i)Upper abdominal pain
•ii)Upper abdominal discomfort
•iii)Post Prandial fullness
•iv)Upper abdominal bloating
•v)Early satiety
•vii)Vomiting
•4. Female Subjects of childbearing potential, willing to use effective contraception during the study and willing to undergo pregnancy test.
•5. Written informed consent signed by patient and willing to comply with the study procedure.

•1. Pregnant and lactating female patients.
•2. Subject having heartburn as the most bothersome symptom or if they had moderate or severe heartburn during the baseline period.
•3. History of peptic ulcer or gastro esophageal reflux disease (GERD).
•4. Current prominent symptoms of irritable bowel syndrome.
•5. Subjects who have had a previous gastrointestinal surgery except appendectomy and laparoscopic cholecystectomy.
•6. Use of aspirin or other non-steroidal anti-inflammatory drugs antibiotics, H2 receptor blockers, bismuth, or proton pump inhibitors and prokinetics in the preceding two weeks.
•7. Participation of other clinical trials within the last 1 month.
•8. Evidence or history of clinically significant (in the judgment of the Investigator) haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies.
•9. Patients with alcohol abuse (daily alcohol intake more than 40g), drug dependence or neuropsychiatric disorders that are difficult to control, as well as others who are not appropriate to participate in a drug trial;
•10. Patient with known history of hypersensitivity to any ingredient of investigational product. Any medical condition deemed exclusionary by the Principal Investigator.
•11. Subject has a history of drug and / or alcohol abuse at the time of enrolment.

发起方