Conditions: Constipation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 65
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare the safety and tolerability of oral ingestion of PEG 3350 solution concentrate to oral ingestion of a placebo solution concentrate, in participants with constipation.

Detailed description:
This was a randomized, single-blind, placebo-controlled study to evaluate the proportion of participants with abnormalities of the oral mucosa detected by visual examination of the oral cavity in the polyethylene glycol (PEG) 3350 group compared with the placebo group. The study was also to evaluate the proportion of participants with abnormalities of the esophageal mucosa detected by endoscopic examination of the esophagus in the PEG 3350 group compared with the placebo group, and to compare the safety and tolerability by evaluation of the proportion of participants with the occurrence of adverse events (AEs) or adverse drug reactions.

Arms:
arm 1: Participants will receive a 17 g dose of PEG 3350 solution concentrate in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, will be provided for use as a rescue medication if a participant has not had a bowel movement for 72 hours after start of treatment. arm 2: Participants will receive a 17 g dose of Placebo solution concentrate in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, will be provided for use as a rescue medication if a participant has not had a bowel movement for 72 hours after start of treatment.

Interventions: intervention 1: Polyethylene Glycol (PEG 3350) intervention 2: Placebo intervention 3: Bisacodyl laxative tablets (rescue medication)
Intervention descriptions: intervention 1: Oral 17 g dose of PEG 3350 solution concentrate in a volume of approximately 30 mL, once a day, for 14 days. intervention 2: Oral 17 g dose of Placebo solution concentrate in a volume of approximately 30 mL, once a day, for 14 days. intervention 3: 5.0 mg tablets, 1 to 3 tablets in a single daily dose, to be provided for use as rescue medication if participant has not had bowel movement for 72 hours after start of treatment.

Protocol document: