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Kristalose · 1 trial · 1 indication
To evaluate the primary objective of hydrogen and methane gas production as measured by: • Pre- and post-dose breath analysis for hydrogen and methane gas.
| Arm | Type | Description |
|---|---|---|
| Kristalose | EXPERIMENTAL | Kristalose as Bowel Evacuant |
| Name | Type | Description |
|---|---|---|
| Kristalose | DRUG | The dosing regimen of Kristalose will be nine 20-gram doses (one dose every 30 minutes for 4 straight hours) taken the evening before the colonoscopy procedure. |
Inclusion Criteria: Patients requiring bowel evacuation for colonoscopy Exclusion Criteria: 1. Patients with galactosemia (galactose-sensitive diet). 2. Patients known to be hypersensitive to any of the components of Kristalose. 3. Patients with possible bowel obstruction, previous colonic surger...
Kristalose is a small molecule being studied as a bowel evacuant prior to colonoscopy. It is intended to prepare the bowel for the procedure. The drug is in clinical development for this gastrointestinal indication and is not yet approved for this use.
Kristalose is being developed by Cumberland Pharmaceuticals Inc., a company traded on the Nasdaq under the ticker CPIX. The company is conducting clinical research on the drug for use as a bowel evacuant prior to colonoscopy.
Kristalose is in Phase 1 clinical development as a bowel evacuant prior to colonoscopy. A Phase 1 trial has been completed, and the drug remains investigational for this indication. It is not FDA approved for this use.
Kristalose has one completed clinical trial, NCT01256541, titled 'Kristalose as Bowel Evacuant Prior to Colonoscopy.' This Phase 1 study enrolled 20 participants in the United States and was not randomized, double-blind, or controlled.
Kristalose is the brand name for lactulose, a synthetic sugar used as a laxative. In the context of this clinical trial, it is being evaluated specifically as a bowel evacuant prior to colonoscopy. The drug is not approved for this particular use.