Efficacy and Safety of PEG 3350 for Treatment of Chronic Constipation

Constipation - Functional Clinical Trial

Official title:

Efficacy and Safety of PEG 3350 for Treatment of Chronic Constipation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03957668
• Other study ID #: 19-04-0392
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 7, 2019
• Est. completion date: October 31, 2020

Study information

• Verified date: October 2020
• Source: Fakultas Kedokteran Universitas Indonesia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 184
• Est. completion date: October 31, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Constipation
• Constipation - Functional

Intervention

Drug:
• PEG 3350
PEG 3350 17 g once daily for 14 days
• Lactulose
Lactulose 10 g once daily for 14 days

Locations

Country	Name	City	State
Indonesia	Puskesmas Kelurahan Paseban	Jakarta	DKI Jakarta
Indonesia	Puskesmas Kelurahan Petamburan	Jakarta	DKI Jakarta
Indonesia	RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital)	Jakarta	DKI Jakarta

Sponsors (2)

Lead Sponsor	Collaborator
Fakultas Kedokteran Universitas Indonesia	PT Meiji Indonesia

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with adverse events (AEs)	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	7 days, 14 days
Other	Number of participants with serious adverse events (SAEs)		7 days, 14 days
Primary	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
Primary	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	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
Secondary	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
Secondary	Overall rating of effectiveness at 1 week	Effective: patients with = 3 bowel movements per 7-day period	7 days
Secondary	Overall rating of effectiveness at 2 weeks	Effective: patients with = 3 bowel movements per 7-day period	14 days