Efficacy and Safety of PEG 3350 for Treatment of Chronic Constipation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-07

Study Completion Date

2020-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Constipation - Functional

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

PEG 3350

Intervention Type DRUG

PEG 3350 17 g once daily for 14 days

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

Group Type ACTIVE_COMPARATOR

Lactulose

Intervention Type DRUG

Lactulose 10 g once daily for 14 days

Interventions

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PEG 3350

PEG 3350 17 g once daily for 14 days

Intervention Type DRUG

Lactulose

Lactulose 10 g once daily for 14 days

Intervention Type DRUG

Eligibility Criteria

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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.