Constipation - Functional
Conditions
Keywords
PEG 3350, Constipation
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.
Interventions
DRUGPEG 3350
PEG 3350 17 g once daily for 14 days
DRUGLactulose
Lactulose 10 g once daily for 14 days
Sponsors
PT Meiji Indonesia
Fakultas Kedokteran Universitas Indonesia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
Indonesia
Outcome results
None listed