Study Details

Description

Study Title

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.

Objectives

Primary Objective: To evaluate the efficacy of OLNP-06 versus placebo in subjects with functional dyspepsia.
Secondary Objective: To evaluate the safety of OLNP-06 versus placebo in subjects with functional dyspepsia.

Investigational Medicinal Product(s)

Test Product(s): OLNP-06 in 100 mg capsules.
Manufactured and Marketed by: Olene Life Sciences Pvt. Ltd.

Study Design

POC Trial with 3 Groups:
- Group I: 100 mg OLNP-06, once daily.
- Group II: 100 mg OLNP-06, twice daily.
- Placebo Group: Placebo capsule, twice daily.

Study Population

Sample Size: 66 patients with functional dyspepsia.

Inclusion Criteria

-          Male or female subjects aged 18 - 55 years.

-          Diagnosis of functional dyspepsia (FD), including Postprandial Distress Syndrome, fulfilling the Rome-III criteria.

-           Presence of at least one of the following two symptoms for at least 6 months: postprandial fullness or early satiety;

-          or presence of two or more of the following symptoms at a moderate or severe level on Likert scale within the previous 3 months (at least one symptom of postprandial fullness, upper abdominal bloating, or early satiety): upper abdominal pain, upper abdominal discomfort, postprandial fullness, upper abdominal bloating, early satiety, nausea, vomiting.

-          Female subjects of childbearing potential willing to use effective contraception during the study and undergo pregnancy tests.

-          Written informed consent signed by the patient, indicating willingness to comply with the study procedure.

Exclusion Criteria

- Pregnant and lactating female patients.
- Subjects having heartburn as the most bothersome symptom or moderate/severe heartburn during the baseline period.
- History of peptic ulcer or gastroesophageal reflux disease (GERD).
- Current prominent symptoms of irritable bowel syndrome.
- Previous gastrointestinal surgery, bariatric surgery, except appendectomy and laparoscopic cholecystectomy.
- Use of aspirin, non-steroidal anti-inflammatory drugs, antibiotics, H2 receptor blockers, bismuth, proton pump inhibitors, or prokinetics in the preceding two weeks.
- Participation in other clinical trials within the last 1 month.
- Evidence or history of clinically significant diseases or malignancies, as judged by the Investigator.
- Patients with alcohol abuse, drug dependence, or neuropsychiatric disorders that are difficult to control.
- Known history of hypersensitivity to any ingredient of the investigational product.
- Subjects with a history of drug or alcohol abuse at the time of enrolment.

Study Duration

Approximately 6 weeks.

Visit and Evaluation Schedule

- Day -7: Screening Visit
- Day 0: Baseline - Randomization

- Day 1: Evaluation Day
- Day 7: Follow-Up Visit
- Day 14 ± 02: Follow-Up Visit
- Day 28 ± 02: End of Study

- Day 42 ± 02: Post-Treatment Effect: Assessment 2 weeks after stopping the supplementation.

Efficacy Endpoints

Primary Outcome Measure:

Primary outcome measure is change in score of global assessment of overall treatment efficacy (OTE) questionnaire from baseline to end of 4 weeks of treatment

Subjects will complete a global assessment of overall treatment efficacy (OTE) questionnaire at before the start of supplementation on Day 1 and weekly until the end of the study.

 Responses will be scored on a seven-point Likert scale, and the improvement rate will be calculated by combining the percentage of subjects who are ‘extremely improved’ or ‘improved.’

Secondary Outcome Measures:
- Elimination rate (score 0) of all three major symptoms (postprandial fullness, upper abdominal bloating, and early satiety) will be assessed at baseline and at the end of the 4-week treatment period.
- Elimination rate for each individual symptom (upper abdominal pain, upper abdominal discomfort, postprandial fullness, upper abdominal bloating, early satiation, excessive belching, nausea, vomiting and heartburn) will be assessed daily based on subject diaries.

SIBO test- hydrogen breath test will be carried out at baseline and at the end of the 4-week treatment period.

Subject Perceived Assessment: At the end of the trial, subjects will provide their overall assessment of treatment.

Safety Endpoints

- Changes in laboratory safety parameters from baseline to the end of the study.

- Incidence of adverse events.
- Change in vital parameters.

Ethical Considerations

The study will commence only after written approval is obtained from the Institutional Ethics Committee for the submitted protocol, informed consent documents (ICD), and other relevant documents. It will be conducted according to ICMR Ethical Guidelines for Biomedical and Health Research involving human participants (2017), Schedule Y, ICH-GCP guidelines, applicable local regulations, and the Declaration of Helsinki (Fortaleza, Brazil, October 2013).