Efficacy and Safety of PEG 3350 for Treatment of Chronic Constipation

• Status: Active, not recruiting
• Trial end date: 2020-10-31
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to determine the efficacy and safety of PEG 3350 (polyethylene glycol 3350) for short-term treatment of chronic constipation in adults.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fakultas Kedokteran Universitas Indonesia
• Collaborator: PT Meiji Indonesia
• Treatments: Lactulose; Polyethylene glycol 3350

Criteria

Inclusion Criteria:

1. Males and females aged ≥ 18 years.

2. Body Mass Index (BMI) ≥ 18.5

3. Organic bowel disease will be ruled out by Fecal Immunochemical Test (FIT) and/or colonoscopy.

4. Must have ≤ 2 bowel movements during a 7-day qualification period.

5. In otherwise good health as judged by a physical examination and laboratory testing.

6. Not taking medications known to affect bowel function in one week before study.

7. Willing to participate in the study by signing the informed consent.

Exclusion Criteria:

1. Hypersensitive to the study medication.

2. obstructive ileus.

3. Irritable bowel syndrome (IBS) or inflammatory bowel disease (IBD)