Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 used for constipation. It is being studied as an oral solution for the treatment of constipation in adults. The drug is currently in Phase 2 clinical development for this gastrointestinal condition.
Polyethylene Glycol is being developed by Bayer AG, a company traded under the ticker BAYRY. The drug is in Phase 2 clinical development for the treatment of constipation.
Polyethylene Glycol is in Phase 2 clinical development. It is an investigational drug being studied for the treatment of constipation. The drug is not approved and remains in clinical testing.
Polyethylene Glycol has one completed Phase 2 clinical trial, NCT01885104, which evaluated the safety and tolerability of oral polyethylene glycol solution in participants with constipation. The trial enrolled 65 adults and was placebo-controlled.
Polyethylene Glycol is also known as PEG 3350. The clinical trial NCT01885104 studied oral polyethylene glycol (PEG 3350) solution in participants with constipation.