Efficacy and Safety of PEG 3350 for Treatment of Chronic Constipation

Sponsor

Fakultas Kedokteran Universitas Indonesia (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03957668

Collaborator

PT Meiji Indonesia (Other)

184

Enrollment

Locations

Arms

10.8

Anticipated Duration (Months)

61.3

Patients Per Site

5.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Constipation - Functional	Drug: PEG 3350 Drug: Lactulose	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

184 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Efficacy and Safety of PEG 3350 for Treatment of Chronic Constipation

Actual Study Start Date :

Dec 7, 2019

Actual Primary Completion Date :

Sep 30, 2020

Anticipated Study Completion Date :

Oct 31, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Other Outcome Measures

Number of participants with adverse events (AEs) [7 days, 14 days]
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
Number of participants with serious adverse events (SAEs) [7 days, 14 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Puskesmas Kelurahan Petamburan	Jakarta	DKI Jakarta	Indonesia	10260
2	RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital)	Jakarta	DKI Jakarta	Indonesia	10430
3	Puskesmas Kelurahan Paseban	Jakarta	DKI Jakarta	Indonesia	10440