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Efficacy and Safety of PEG 3350 for Treatment of Chronic Constipation

Primary Purpose

Constipation - Functional

Status
Unknown status
Phase
Phase 3
Locations
Indonesia
Study Type
Interventional
Intervention
PEG 3350
Lactulose
Sponsored by
Fakultas Kedokteran Universitas Indonesia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation - Functional focused on measuring PEG 3350, Constipation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Puskesmas Kelurahan Petamburan
  • RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital)
  • Puskesmas Kelurahan Paseban

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PEG 3350

Lactulax

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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
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
Overall rating of effectiveness at 1 week
Effective: patients with ≥ 3 bowel movements per 7-day period
Overall rating of effectiveness at 2 weeks
Effective: patients with ≥ 3 bowel movements per 7-day period

Full Information

First Posted
May 10, 2019
Last Updated
October 19, 2020
Sponsor
Fakultas Kedokteran Universitas Indonesia
Collaborators
PT Meiji Indonesia
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1. Study Identification

Unique Protocol Identification Number
NCT03957668
Brief Title
Efficacy and Safety of PEG 3350 for Treatment of Chronic Constipation
Official Title
Efficacy and Safety of PEG 3350 for Treatment of Chronic Constipation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 7, 2019 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
October 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fakultas Kedokteran Universitas Indonesia
Collaborators
PT Meiji Indonesia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation - Functional
Keywords
PEG 3350, Constipation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
184 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PEG 3350
Arm Type
Experimental
Arm Description
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.
Arm Title
Lactulax
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
PEG 3350
Intervention Description
PEG 3350 17 g once daily for 14 days
Intervention Type
Drug
Intervention Name(s)
Lactulose
Intervention Description
Lactulose 10 g once daily for 14 days
Primary Outcome Measure Information:
Title
Change of number of bowel movements at 1 week
Description
An increase in the number of bowel movements (defecation) per 7-day period indicates a positive result.
Time Frame
7 days
Title
Change of number of bowel movements at 2 weeks
Description
An increase in the number of bowel movements (defecation) per 7-day period indicates a positive result.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Symptom scores at 1 week
Description
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
Title
Symptom scores at 2 weeks
Description
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
14 days
Title
Overall rating of effectiveness at 1 week
Description
Effective: patients with ≥ 3 bowel movements per 7-day period
Time Frame
7 days
Title
Overall rating of effectiveness at 2 weeks
Description
Effective: patients with ≥ 3 bowel movements per 7-day period
Time Frame
14 days
Other Pre-specified Outcome Measures:
Title
Number of participants with adverse events (AEs)
Description
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
Time Frame
7 days, 14 days
Title
Number of participants with serious adverse events (SAEs)
Time Frame
7 days, 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murdani Abdulah
Organizational Affiliation
Fakultas Kedokteran Universitas Indonesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Puskesmas Kelurahan Petamburan
City
Jakarta
State/Province
DKI Jakarta
ZIP/Postal Code
10260
Country
Indonesia
Facility Name
RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital)
City
Jakarta
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia
Facility Name
Puskesmas Kelurahan Paseban
City
Jakarta
State/Province
DKI Jakarta
ZIP/Postal Code
10440
Country
Indonesia

12. IPD Sharing Statement

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Efficacy and Safety of PEG 3350 for Treatment of Chronic Constipation

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