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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 being studied as a bowel evacuant prior to colonoscopy, meaning it is intended to clear the bowel before the procedure. It is a small molecule in the gastrointestinal therapeutic area. Cumberland Pharmaceuticals Inc. is developing it for this bowel preparation indication.
Kristalose is developed by Cumberland Pharmaceuticals Inc., which trades under the ticker CPIX. The company is the sponsor of the clinical program studying the drug as a bowel evacuant prior to colonoscopy in the United States.
Kristalose is in Phase 1 clinical development. It is an investigational drug and is not approved for the bowel evacuant prior to colonoscopy indication. The program includes one completed Phase 1 trial, and no trials are currently active.
Kristalose has been studied in one completed Phase 1 trial, NCT01256541, titled Kristalose as Bowel Evacuant Prior to Colonoscopy. That trial enrolled 20 participants in the United States, included adults 18 years and older of all sexes, and was uncontrolled without randomization or double blinding.
The single completed Phase 1 trial of Kristalose, NCT01256541, enrolled 20 participants. It was an uncontrolled study conducted in the United States, with no randomization and no double blinding, and it enrolled adults aged 18 years and older of all sexes.