A Phase 3 interventional study of PEG 3350 and Lactulose in Constipation - Functional, sponsored by Fakultas Kedokteran Universitas Indonesia. Status unknown at 3 sites in Indonesia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-20.
Sponsored by Fakultas Kedokteran Universitas Indonesia · Phase 3, Interventional, and Treatment
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.
1,018 studies on the registry are indexed under Constipation; 139 are open to participants now.
This study's planned enrollment of 184 is above the median of 80 across 850 interventional studies indexed under Constipation.
Browse Constipation studies →Fakultas Kedokteran Universitas Indonesia is the lead sponsor of 36 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
PEG 3350 17 g once daily for 14 days
Lactulose 10 g once daily for 14 days
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.
Time frame: 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.
Time frame: 14 days
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
Time frame: 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
Time frame: 14 days
Overall rating of effectiveness at 1 week
Effective: patients with ≥ 3 bowel movements per 7-day period
Time frame: 7 days
Overall rating of effectiveness at 2 weeks
Effective: patients with ≥ 3 bowel movements per 7-day period
Time frame: 14 days
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
Time frame: 7 days, 14 days
Number of participants with serious adverse events (SAEs)
Time frame: 7 days, 14 days
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This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Fakultas Kedokteran Universitas Indonesia