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Also known as Polyethylene Glycol (PEG 3350)
Polyethylene Glycol · 1 trial · 1 indication
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).
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).
| Arm | Type | Description |
|---|---|---|
| PEG 3350 | EXPERIMENTAL | 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. |
| Placebo | PLACEBO_COMPARATOR | 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. |
| Name | Type | Description |
|---|---|---|
| Polyethylene Glycol (PEG 3350) | DRUG | Oral 17 g dose of PEG 3350 solution concentrate in a volume of approximately 30 mL, once a day, for 14 days. |
| Placebo | DRUG | Oral 17 g dose of Placebo solution concentrate in a volume of approximately 30 mL, once a day, for 14 days. |
| Bisacodyl laxative tablets (rescue medication) | DRUG | 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. |
Inclusion Criteria: * ambulatory male or female with no history or current evidence of other conditions or abnormalities that would affect study results or interfere with participation for full duration of study * meets diagnostic criteria for functional constipation. This includes loose stools tha...
Polyethylene Glycol is being studied for the treatment of constipation. It is an investigational small molecule developed by Bayer AG. The clinical program has focused on adults 18 years and older with constipation, evaluating safety and tolerability of an oral solution.
Polyethylene Glycol targets EPOR, the erythropoietin receptor, and acts as an agonist at that receptor. This target class distinguishes it from conventional osmotic laxatives, which act physically in the gut rather than through a defined molecular target.
Polyethylene Glycol is developed by Bayer AG, which trades under the ticker BAYRY. Bayer sponsored the clinical trial identified as MK-8114-003, which evaluated the oral PEG 3350 solution in participants with constipation.
Polyethylene Glycol is in Phase 2 clinical development for constipation. It is investigational and has not been approved for marketing. The Phase 2 trial has been completed, and no active trials are currently listed for this asset.
Polyethylene Glycol has been evaluated in one completed Phase 2 trial, NCT01885104, titled Safety and Tolerability of Oral Polyethylene Glycol (PEG 3350) Solution in Participants With Constipation. The trial enrolled 65 adults, was randomized and placebo controlled, and did not use a double-blind design.
Yes, Polyethylene Glycol is also known as Polyethylene Glycol (PEG 3350). The two names refer to the same investigational oral solution developed by Bayer AG, and the Phase 2 trial NCT01885104 used the PEG 3350 designation in its title.