Efficacy and Safety of PEG 3350 for Treatment of Chronic Constipation

Study Overview
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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.

Official Title
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Efficacy and Safety of PEG 3350 for Treatment of Chronic Constipation

Conditions
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Constipation - Functional

Intervention / Treatment
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* Drug: PEG 3350
* Drug: Lactulose


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEG 3350<br>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<br>* PEG 3350 17 g once daily for 14 days<br>|
| Active Comparator: Lactulax<br>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<br>* Lactulose 10 g once daily for 14 days<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PEG 3350, Constipation