Efficacy and Safety of PEG 3350 for Treatment of Chronic Constipation

Phase 3

• Conditions: Constipation - Functional
• Interventions: Drug: PEG 3350; Drug: Lactulose

• Registration Number: NCT03957668
• Lead Sponsor: Fakultas Kedokteran Universitas Indonesia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-10
• Study First Submitted QC: 2019-05-19
• Study First Posted: 2019-05-21
• Study Start: 2019-12-07
• Primary Completion: 2020-09-30
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-19
• Last Update Posted: 2020-10-20
• Study Completion: 2020-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 184

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEG 3350	PEG 3350	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.
Lactulax	Lactulose	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

Primary Outcome Measures

Name	Time	Method
Change of number of bowel movements at 1 week	7 days	An increase in the number of bowel movements (defecation) per 7-day period indicates a positive result.
Change of number of bowel movements at 2 weeks	14 days	An increase in the number of bowel movements (defecation) per 7-day period indicates a positive result.

Secondary Outcome Measures

Name	Time	Method
Symptom scores at 1 week	7 days	* 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
Symptom scores at 2 weeks	14 days	* 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
Overall rating of effectiveness at 1 week	7 days	Effective: patients with ≥ 3 bowel movements per 7-day period
Overall rating of effectiveness at 2 weeks	14 days	Effective: patients with ≥ 3 bowel movements per 7-day period

Trial Locations

Locations (3)

Puskesmas Kelurahan Paseban; 🇮🇩 Jakarta, DKI Jakarta, Indonesia

Puskesmas Kelurahan Petamburan; 🇮🇩 Jakarta, DKI Jakarta, Indonesia

RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital); 🇮🇩 Jakarta, DKI Jakarta, Indonesia