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Crystalline Lactulose · 1 trial · 1 indication
To evaluate the primary objective of efficacy of the split-dose, the following endpoint will be measured: o Physician's determination of the cleanliness of the colon will be evaluated by completion of the Boston bowel prep scale.
| Arm | Type | Description |
|---|---|---|
| Evening Only (full-dose) | ACTIVE_COMPARATOR | The dosing regimen of Crystalline lactulose will be four 45-gram doses (one dose every 60 minutes for 4 straight hours) taken the evening before the colonoscopy procedure. |
| Split-dose | EXPERIMENTAL | The dosing regimen of Crystalline lactulose will be three 45-gram doses (one dose every 60 minutes for 3 straight hours) taken the evening before the colonoscopy procedure followed by one 45-gram dose the morning before the colonoscopy procedure. |
| Name | Type | Description |
|---|---|---|
| Crystalline Lactulose | DRUG | - |
Inclusion Criteria: * Patients requiring bowel evacuation for colonoscopy Exclusion Criteria: * Patients with galactosemia (galactose-sensitive diet) * Patients known to be hypersensitive to any of the components of Crystalline Lactulose * Patients with a history of a failed bowel preparation * P...
Crystalline Lactulose is an investigational small molecule being studied for use in colonoscopy. It is being evaluated as a bowel preparation agent to cleanse the colon before the procedure. The drug is currently in Phase 2 clinical development and has not been approved by the FDA.
Crystalline Lactulose is being developed by Cumberland Pharmaceuticals Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CPIX. The company is conducting clinical trials to evaluate the safety and efficacy of this drug for colonoscopy preparation.
Crystalline Lactulose is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 2 clinical trial has been completed to assess its safety, efficacy, and patient preference as a preparation for colonoscopy in adults.
Crystalline Lactulose has one completed clinical trial, identified as NCT01650870. This Phase 2 study, titled "Safety, Efficacy, and Patient Preference of Split-Dose Crystalline Lactulose as a Preparation for Colonoscopy in Adults," enrolled 40 participants in the United States. The trial was active-controlled and randomized.
Crystalline Lactulose is a specific crystalline form of lactulose, a synthetic sugar used as a laxative. While it shares the same active ingredient, the crystalline formulation is being developed specifically for colonoscopy preparation. The drug is currently in Phase 2 trials and is not yet approved for this use.