Efficacy and Safety evaluation of OLNP-06 in Subjects with Functional Dyspepsia.

Phase 3

• Conditions: Health Condition 1: K30- Functional dyspepsia

• Registration Number: CTRI/2019/09/021019
• Lead Sponsor: Olene Life Sciences Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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

or

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

vi)Nausea

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Treatment efficacy (OTE)Timepoint: Day 14 and Day 28

Secondary Outcome Measures

Name	Time	Method
Elimination rate (score 0) of all three major symptoms <br/ ><br>Timepoint: Screening, Day 14 and Day 28;Elimination rate for each individual SymptomTimepoint: Screening, Day 14 and Day 28