Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Full dose preparation · 1 trial · 1 indication
Efficacy assessed by the physician's determination of the cleanliness of the colon using the cumulative Boston Bowel Preparation Scale (BBPS) score. The cumulative score is derived from three segmental scores assessed from the following three colonic segments: right colon, transverse colon, and left colon. Segment scores range from 0 to 3 with the following abbreviated definitions: 0=mucosa not visible; 1=a portion of the mucosa is visible; 2=minor residue, but mucosa is seen well; 3=entire mucosa is seen well with no residue. The cumulative BBPS score is the sum of the three segment scores such that a cumulative score of 9 represents a colon with maximum mucosa visible and a score of 0 represents minimal visibility.
| Arm | Type | Description |
|---|---|---|
| Full dose preparation; AM colonoscopy | EXPERIMENTAL | Four hourly doses of lactulose for oral solution are taken in the evening. The colonoscopy is initiated prior to noon on the following day. |
| Full dose preparation; PM colonoscopy | EXPERIMENTAL | Four hourly doses of lactulose for oral solution are taken in the evening. The colonoscopy is initiated after noon on the following day. |
| Split dose preparation; AM colonoscopy | EXPERIMENTAL | Three hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure; one dose is taken on the morning of the procedure. The colonoscopy is initiated prior to noon. |
| Split dose preparation; PM colonoscopy | EXPERIMENTAL | Three hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure; one dose is taken on the morning of the procedure. The colonoscopy is initiated after noon. |
| Name | Type | Description |
|---|---|---|
| Full dose preparation | DRUG | - |
| Split dose preparation | 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 lactulose for oral solution. * Patients with an abnormality on screening blood ...
Full dose preparation is a small molecule drug being developed for colonoscopy preparation, a gastrointestinal procedure. It is an investigational product studied in adults to prepare the colon for colonoscopy. The drug is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
Full dose preparation is being developed by Cumberland Pharmaceuticals Inc., a company listed on the NASDAQ under the ticker symbol CPIX. The company is conducting clinical research on this drug for use in colonoscopy preparation, with the goal of establishing its safety and efficacy in adult patients.
Full dose preparation is in Phase 2 clinical development. It has completed one Phase 2 trial, which was a randomized, double-blind, controlled study. The drug remains investigational and is not yet approved for commercial use. Further clinical studies may be needed to support regulatory approval.
Full dose preparation has been studied in one completed clinical trial, identified as NCT01887470, titled "2 Regimens of Lactulose for Colonoscopy Preparation in Adults." This Phase 2 trial enrolled 55 participants in the United States, including healthy volunteers, and evaluated the drug's effects on colonoscopy preparation.
Full dose preparation is a drug being developed by Cumberland Pharmaceuticals Inc. for colonoscopy preparation. The clinical trial for this drug, NCT01887470, involved lactulose regimens, suggesting that the active ingredient may be lactulose. However, the drug is referred to as Full dose preparation in the development program.