Efficacy and Safety of PEG 3350 for Treatment of Chronic Constipation

NCT03957668 | Unknown Phase 3

• 1 other identifier: 19-04-0392
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 3

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.

Conditions

Constipation - Functional

Keywords

PEG 3350; Constipation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Symptom scores at 1 week

  7 days

• Symptom scores at 2 weeks

  14 days

• Overall rating of effectiveness at 1 week

  7 days

• Overall rating of effectiveness at 2 weeks

  14 days

Other Outcomes (2)

• Number of participants with adverse events (AEs)

  7 days, 14 days

• Number of participants with serious adverse events (SAEs)

  7 days, 14 days

Study Arms (2)

PEG 3350

EXPERIMENTAL

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

Lactulax

ACTIVE COMPARATOR

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

Interventions

PEG 3350 DRUG

PEG 3350 17 g once daily for 14 days

PEG 3350

Lactulose DRUG

Lactulose 10 g once daily for 14 days

Lactulax

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females aged ≥ 18 years.
• Body Mass Index (BMI) ≥ 18.5
• Organic bowel disease will be ruled out by Fecal Immunochemical Test (FIT) and/or colonoscopy.
• Must have ≤ 2 bowel movements during a 7-day qualification period.
• In otherwise good health as judged by a physical examination and laboratory testing.
• Not taking medications known to affect bowel function in one week before study.
• Willing to participate in the study by signing the informed consent.

You may not qualify if:

• Hypersensitive to the study medication.
• obstructive ileus.
• Irritable bowel syndrome (IBS) or inflammatory bowel disease (IBD)

Sponsors & Collaborators

• Fakultas Kedokteran Universitas Indonesia: lead
• PT Meiji Indonesia: collaborator

Study Sites (3)

Puskesmas Kelurahan Petamburan

Jakarta, DKI Jakarta, 10260, Indonesia

Location

RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital)

Jakarta, DKI Jakarta, 10430, Indonesia

Location

Puskesmas Kelurahan Paseban

Jakarta, DKI Jakarta, 10440, Indonesia

Location

MeSH Terms

Conditions

Constipation

Interventions

polyethylene glycol 3350; Lactulose

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Murdani Abdulah

  Fakultas Kedokteran Universitas Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: May 21, 2019
• Study Start: December 7, 2019
• Primary Completion: September 30, 2020
• Study Completion: October 31, 2020
• Last Updated: October 20, 2020

Record last verified: 2020-10

Locations

ID (3)