Efficacy and Safety of PEG 3350 for Treatment of Chronic Constipation

Fakultas Kedokteran Universitas Indonesia184 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

184

Conditions

Constipation - Functional

Interventions

PEG 3350DRUG

PEG 3350 17 g once daily for 14 days

LactuloseDRUG

Lactulose 10 g once daily for 14 days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (3)

Puskesmas Kelurahan Petamburan

Jakarta, DKI Jakarta, Indonesia

RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital)

Jakarta, DKI Jakarta, Indonesia

Puskesmas Kelurahan Paseban

Jakarta, DKI Jakarta, Indonesia

Outcomes

Primary Outcomes

Change of number of bowel movements at 1 week

An increase in the number of bowel movements (defecation) per 7-day period indicates a positive result.

Time frame: 7 days

Change of number of bowel movements at 2 weeks

An increase in the number of bowel movements (defecation) per 7-day period indicates a positive result.

Time frame: 14 days

Secondary Outcomes

Symptom scores at 1 week

* Stool consistency: 0 = hard, 1 = firm, 2 = soft, 3 = loose, 4 = watery (by anamnesis - visual comparison) * Stool passage: 0 = strain, 1 = easy, 2 = loss of control (by anamnesis) * Cramping and rectal irritation associated with each bowel movement: 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = have to discontinue (by anamnesis) * Flatus: 0 = none, 1 = moderate, 2 = occasional, 3 = frequent, 4 = very frequent

Time frame: 7 days

Symptom scores at 2 weeks

Time frame: 14 days

Overall rating of effectiveness at 1 week

Effective: patients with ≥ 3 bowel movements per 7-day period

Time frame: 7 days

Overall rating of effectiveness at 2 weeks

Effective: patients with ≥ 3 bowel movements per 7-day period

Time frame: 14 days

Data from ClinicalTrials.gov

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