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PEG 3350 laxative plus electrolytes/Macrogol · 1 trial · 1 indication
A successful BM was defined as a BM with no straining or hard/lumpy stools.
| Arm | Type | Description |
|---|---|---|
| PEG + E, 13.125 g | EXPERIMENTAL | Single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time |
| PEG + E, 26.25 g | EXPERIMENTAL | Two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time |
| PEG + E, 39.375 g | EXPERIMENTAL | Three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time |
| Name | Type | Description |
|---|---|---|
| PEG 3350 laxative plus electrolytes (PEG + E)/Macrogol (Movicol®, BAY81-8430) | DRUG | 13.125 g of PEG 3350 powder with approximately 0.6 g of electrolytes |
Inclusion Criteria: * A willingness to participate in the study and comply with its procedures * Must be ambulatory * Male or female subjects aged 18 years or older who met two or more of the following modified Rome III-based criteria for constipation: (a) straining during at least 25% of defecatio...
PEG 3350 laxative plus electrolytes/Macrogol is being developed for the treatment of constipation. It is a small molecule in the gastrointestinal therapeutic area. Bayer AG is running clinical development for this constipation indication, and the program has reached Phase 2 testing.
Bayer AG is the developer of PEG 3350 laxative plus electrolytes/Macrogol. Bayer trades on the OTC market under the ticker BAYRY. The company sponsored the Phase 2 dose-finding study of this constipation candidate.
PEG 3350 laxative plus electrolytes/Macrogol is in Phase 2 development for constipation. The program's single recorded trial, NCT01212445, was a Phase 2 dose-finding study that has completed. No active trials are currently listed for this candidate.
One trial has studied PEG 3350 laxative plus electrolytes/Macrogol: NCT01212445, titled Dose-Finding Trial of Polyethylene Glycol 3350 Laxative Plus Electrolytes for the Treatment of Constipation, under protocol P07515. It was a completed Phase 2 randomized, controlled study that enrolled 154 adults aged 18 and older in Ireland.
Yes. PEG 3350 laxative plus electrolytes/Macrogol is also known as PEG 3350 laxative plus electrolytes (PEG + E), Macrogol, Movicol, and BAY81-8430. These names refer to the same constipation candidate developed by Bayer AG.
The Phase 2 trial of PEG 3350 laxative plus electrolytes/Macrogol, NCT01212445, enrolled 154 participants. It was a randomized, controlled dose-finding study in adults with constipation, conducted in Ireland, and it has completed. The study was not double-blind.