Recent Updates
Recently added Catalysts

Black raspberry Slurry

Phase 1

Familial Adenomatous Polyposis | Small molecule | Gastrointestinal |Community Health Systems, Inc.|Last Updated: Feb 15, 2016

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment34

FDA Designations

No designations recorded

Clinical trial landscape

Black raspberry Slurry · 1 trial · 1 indication

Phase 1 1
NCT00770991Lyophilized Black Raspberries in Adults With Familial Adenomatous Polyposis (FAP)Familial Adenomatous Polyposis
COMPLETED34 Analytics
PHASE1COMPLETED
Lyophilized Black Raspberries in Adults With Familial Adenomatous Polyposis (FAP)
Familial Adenomatous PolyposisUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline to End of Study in Number of Rectal Polyps
Baseline and 36 weeks
Change in Burden of Rectal Polyps
Baseline and 36 weeks

The burden was measured as the sum of the number of polyps x size of polyps in mm. The change in burden was determined between baseline and 36 weeks.

Secondary Endpoints

Apoptosis and Cell Proliferation Measured by Percent Difference in Staining.
baseline and 36 weeks
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Black Raspberry (BRB) Slurry plus BRB suppositoriesEXPERIMENTAL20 grams BRB Slurry BID plus two, 730 mg BRB suppositories HS
Black Raspberry (BRB) Placebo Slurry plus BRB suppositoriesEXPERIMENTAL20 grams BRB Placebo Slurry BID plus two, 730 mg BRB suppositories HS

Interventions

NameTypeDescription
Black raspberry (BRB) SlurryDRUG20 grams BRB Slurry
Black Raspberry (BRB) SuppositoriesDRUGTwo, 730 mg BRB suppositories QHS
Black Raspberry (BRB) Placebo SlurryDRUG20 grams BRB placebo slurry
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Diagnosis of familial adenomatous polyposis with at least 5 rectal polyps which are greater than or equal to 2 mm on baseline colonoscopy * Have an endoscopically assessable rectal segment * Have not taken NSAIDs or selective COX-2 inhibitors for two months prior to the study ...

Countries:United States
Unlock Eligibility Criteria