Efficacy and Safety of PEG 3350 for Treatment of Chronic Constipation

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 Overview

• Status: Unknown
• Conditions: Constipation - Functional
• Intervention / Treatment: Drug: PEG 3350; Drug: Lactulose

• Study Type: Interventional
• Enrollment (Anticipated): 184
• Phase: Phase 3

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta, DKI Jakarta, Indonesia, 10260
      • Puskesmas Kelurahan Petamburan
    • Jakarta, DKI Jakarta, Indonesia, 10430
      • RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital)
    • Jakarta, DKI Jakarta, Indonesia, 10440
      • Puskesmas Kelurahan Paseban

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: PEG 3350; PEG 3350 17 g once daily for 14 days
Active Comparator: Lactulax; 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	Drug: Lactulose; Lactulose 10 g once daily for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	7 days
Symptom scores at 2 weeks	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	14 days
Overall rating of effectiveness at 1 week	Effective: patients with ≥ 3 bowel movements per 7-day period	7 days
Overall rating of effectiveness at 2 weeks	Effective: patients with ≥ 3 bowel movements per 7-day period	14 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events (AEs)	The following adverse events may occur after treatment, thus will be evaluated: Headache; Dizziness; Fatigue; Weakness; Nausea; Dry mouth; Abdominal pain / cramping; Flatulence; Rectal irritation; Diarrhea / watery stool	7 days, 14 days
Number of participants with serious adverse events (SAEs)		7 days, 14 days

Collaborators and Investigators

• Sponsor: Fakultas Kedokteran Universitas Indonesia
• Collaborators: PT Meiji Indonesia
• Investigators: Principal Investigator: Murdani Abdulah, Fakultas Kedokteran Universitas Indonesia

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2019
• Primary Completion (Actual): September 30, 2020
• Study Completion (Anticipated): October 31, 2020

Study Registration Dates

• First Submitted: May 10, 2019
• First Submitted That Met QC Criteria: May 19, 2019
• First Posted (Actual): May 21, 2019

Study Record Updates

• Last Update Posted (Actual): October 20, 2020
• Last Update Submitted That Met QC Criteria: October 19, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Constipation; PEG 3350
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation; Gastrointestinal Agents; Laxatives; Lactulose; Polyethylene glycol 3350
• Other Study ID Numbers: 19-04-0392

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No