Efficacy and Safety of PEG 3350 for Treatment of Chronic Constipation

University of Indonesia (UI)

Status and phase: Unknown; Phase 3

Conditions: Constipation - Functional

Treatments: Drug: PEG 3350; Drug: Lactulose

Study type: Interventional

Funder types: Other

Identifiers

NCT03957668

19-04-0392

Details and patient eligibility

About

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.

Enrollment: 184 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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184 participants in 2 patient groups

PEG 3350

Experimental group

Description:

The content of each sachet of PEG 3350 (17 g powder) is dissolved in 240 mL of water, drink it once daily at bedtime, for a duration of 14 days.

Treatment:

Drug: PEG 3350

Lactulax

Active Comparator group

Description:

15 ml of Lactulax syrup (containing 10 g of lactulose) is drunk with 240 ml of water once daily at bedtime, for a duration of 14 days

Treatment:

Drug: Lactulose