Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 developed by Cumberland Pharmaceuticals Inc. as a bowel preparation for colonoscopy in adults. It is a Phase 2 candidate and has not been approved by the FDA. It is being studied as a split-dose preparation intended to cleanse the colon before the procedure.
Crystalline Lactulose is being studied as a preparation for colonoscopy in adults. The goal is to clear the colon before the procedure so the physician can visualize the lining of the colon. It is an investigational product and is not approved for commercial use.
Cumberland Pharmaceuticals Inc., which trades on the Nasdaq under the ticker CPIX, is developing Crystalline Lactulose. The company sponsored the clinical program evaluating the agent as a colonoscopy preparation.
Crystalline Lactulose is in Phase 2 clinical development. It is investigational and has not received FDA approval. The Phase 2 program has been completed, and no trials of this asset are currently listed as active.
Crystalline Lactulose has been evaluated in one completed Phase 2 trial, NCT01650870, titled Safety, Efficacy, and Patient Preference of Split-Dose Crystalline Lactulose as a Preparation for Colonoscopy in Adults. The trial enrolled 40 adults aged 18 and older in the United States and used an active-controlled, randomized design.