Placebo control study of lansoprazole for the treatment of functional dyspepsia in childre

Phase 3

• Conditions: Health Condition 1: K30- Functional dyspepsia

• Registration Number: CTRI/2023/04/052031
• Lead Sponsor: Fourrts pharmaceutical company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 May 2023

Recruitment & Eligibility

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

Inclusion Criteria

FUNCTIONAL DYSPEPSIA (Roams 4 criteria) -

Must include one or more of the following bothersome symptoms at least 4 times a month for at least 2 months prior to diagnosis:

Postprandial fullness

Early satiation

Epigastric pain or burning not associated with defecation

After appropriate evaluation, the symptoms cannot be fully explained by another medical condition

Within FD(Functional dyspepsia) the following subtypes are now adopted:

H2a1.  Postprandial distress syndrome includes bothersome postprandial fullness or early satiation which prevents finishing a regular meal. Supportive features include upper abdominal bloating, postprandial nausea, or excessive belching.

H2a2.  Epigastric pain syndrome which includes all of the following: bothersome (severe enough to interfere with normal activities) pain or burning localized to the epigastrium. The pain is not generalized or localized to other abdominal or chest regions and is not relieved by defecation or passage of flatus. Supportive criteria can include (a) burning quality of the pain but without a retrosternal component, (b) commonly induced or relieved by ingestion of a meal but may occur while fasting.

Exclusion Criteria

1.Patient already on treatment with Proton pump inhibitors (PPI) /H2RA, Prokinetics ,NSAIDS or within 1 week of study commencement

2.Previous Gastrointestinal surgery and diseases (e.g. â?? ulcerative colitis, crohnâ??s disease)

3.Chronic systemic illness (liver,heart,renal diseases)

4.History of H. Pylori infection and treatment in last 6 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified