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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
65
Oral 17 g dose of PEG 3350 solution concentrate in a volume of approximately 30 mL, once a day, for 14 days.
Oral 17 g dose of Placebo solution concentrate in a volume of approximately 30 mL, once a day, for 14 days.
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.
Number of Participants With Inflammation of the Oral Mucosa
Participants underwent visual examination of the oral muscosa at Visit 2 and Visit 3. Measurements were based on 0-3 Likert Scale Scores: 0 = No inflammation (no erythema, no erosion/ulceration); 1 = Mild inflammation (erythema without erosion/ulceration); 2 = Moderate inflammation (erythema with erosion); 3 = Severe inflammation (erythema with ulceration).
Time frame: Visit 2 (Day 1) and Visit 3 (Day 17 ± 2 days), up to 19 days after start of treatment
Number of Participants With Inflammation of the Esophageal Mucosa
Participants underwent endoscopic examination of the esophageal mucosa at Visit 2 and Visit 3. Measurements were based on 0-3 Likert Scale Scores: 0 = No inflammation (no erythema, no erosion/ulceration); 1 = Mild inflammation (erythema without erosion/ulceration); 2 = Moderate inflammation (erythema with erosion); 3 = Severe inflammation (erythema with ulceration).
Time frame: Visit 2 (Day 1) and Visit 3 (Day 17 ± 2 days), up to 19 days after start of treatment
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