Recent Updates
Recently added Catalysts

SGX201

Phase 1

Enteritis | Small molecule | Gastrointestinal |Soligenix, Inc.|Last Updated: Dec 17, 2012

Target and mechanism

ModalitySmall molecule

Also known as SGX201 (delayed release beclomethasone 17,21-dipropionate)

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

SGX201 · 1 trial · 1 indication

Phase 1 1
NCT01073384A Dose Ranging Study of Delayed Release Beclomethasone for Prevention of Acute Enteritis in Patients With Rectal CancerEnteritis
COMPLETED16 Analytics
PHASE1COMPLETED
A Dose Ranging Study of Delayed Release Beclomethasone for Prevention of Acute Enteritis in Patients With Rectal Cancer
Enteritis
NCT0107338416
Unlock trial analytics

Study Endpoints

Primary Endpoints

Preliminary Efficacy
One day prior to and 7 days after radiation therapy
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
BDP 3 mgEXPERIMENTAL1 mg TID
BDP 6 mgEXPERIMENTAL2 mg TID
BDP 9 mgEXPERIMENTAL3 mg TID
BDP 12 mgEXPERIMENTAL4 mg TID

Interventions

NameTypeDescription
SGX201 (delayed release beclomethasone 17,21-dipropionate)DRUGDelayed release beclomethasone 17,21-dipropionate before the first administration of radiation therapy continuing for 7 days after the end of radiation therapy.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Primary rectal cancer * Planned course of conventional neoadjuvant radiation therapy before surgery * Scheduled to receive chemotherapy * \>/= 18 years of age * Negative pregnancy test Exclusion Criteria: * History of acute or chronic regional enteritis or inflammatory bowel...

Countries:United States
Unlock Eligibility Criteria