Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
90 grams of Crystalline Lactulose · 1 trial · 1 indication
Efficacy assessed by the physician's determination of the cleanliness of the colon using the Boston Bowel Preparation Scale (BBPS). 9 is the maximum score, representing an fully cleansed colon; 0 is the minimal score, representing a colon with no cleaning.
| Arm | Type | Description |
|---|---|---|
| 90 grams of Crystalline Lactulose | EXPERIMENTAL | 15 mg of bisacodyl, plus 30 grams of crystalline lactulose x three doses |
| 135 grams of Crystalline Lactulose | EXPERIMENTAL | 15 mg of bisacodyl, plus 45 grams of crystalline lactulose x three doses |
| 180 grams of Crystalline Lactulose | EXPERIMENTAL | 15 mg of bisacodyl, plus 60 grams of crystalline lactulose x three doses |
| Name | Type | Description |
|---|---|---|
| 90 grams of Crystalline Lactulose | DRUG | 15 mg of bisacodyl, plus 30 grams crystalline lactulose x 3 doses |
| 135 grams of Crystalline Lactulose | DRUG | 15 mg of bisacodyl, plus 45 grams crystalline lactulose x 3 doses |
| 180 grams of Crystalline Lactulose | DRUG | 15 mg of bisacodyl, plus 60 grams crystalline lactulose x 3 doses |
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 lactulose for oral solution. * Patients with a known abnormality on screening o...
90 grams of Crystalline Lactulose is an investigational small molecule being studied for colonoscopy preparation. It is intended to be used as a bowel cleansing agent before a colonoscopy procedure. The drug is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
90 grams of Crystalline Lactulose is being developed by Cumberland Pharmaceuticals Inc., a company traded on the NASDAQ under the ticker symbol CPIX. The company is conducting clinical research to evaluate the drug's efficacy and safety for use in colonoscopy preparation.
90 grams of Crystalline Lactulose is in Phase 2 clinical development. It is an investigational drug and has not yet received regulatory approval. The drug is being studied for its potential use in colonoscopy preparation, and its safety and efficacy are still being evaluated in clinical trials.
90 grams of Crystalline Lactulose has been studied in one completed clinical trial, identified as NCT02123017. This Phase 2 trial, titled "Efficacy and Safety of Bisacodyl and Lactulose as a Preparation for Colonoscopy," enrolled 32 participants in the United States. The trial was controlled but not randomized or double-blinded.
90 grams of Crystalline Lactulose is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for colonoscopy preparation. The drug has completed one clinical trial, but it has not yet demonstrated sufficient evidence of safety and efficacy to receive regulatory approval.