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RG1068

Phase 3

Pancreatitis | Small molecule | Gastrointestinal |Repligen Corporation|Last Updated: Feb 23, 2024

Success Probability
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Market & Valuation
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment258
FDA Designations
No designations recorded
Clinical trial landscape

RG1068 · 3 trials · 3 indications

Phase 3 2Phase 2 1
NCT00660335Safety and Efficacy of Synthetic Human Secretin-Enhanced MRCP in Subjects With Abnormalities of the PancreasPancreatitis
COMPLETED258 Analytics
NCT00036244Synthetic Human Secretin in Children With AutismAutism
COMPLETED- Analytics
PHASE3COMPLETED
Safety and Efficacy of Synthetic Human Secretin-Enhanced MRCP in Subjects With Abnormalities of the Pancreas
Pancreatitis
NCT00660335258
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PHASE3COMPLETED
Synthetic Human Secretin in Children With Autism
Autism
NCT00036244-
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Study Endpoints
Primary Endpoints
The primary outcome measure will be assessed by comparing baseline MRCP images and RG1068-enhanced MRCP images for the presence or absence of pancreatic abnormalities.
0 - 10 minutes post dose
Change in Yale-Brown Obsessive Compulsive Scale and
Clinical Global Impression of Change Scale
Secondary Endpoints
The secondary outcome measure will assess safety
up to 30 days
Change in Hamilton Anxiety Scale,
Montgomery-Asberg Depressing Rating Scale, and
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
Currently treated with SSRIEXPERIMENTAL -
Not currently treated with SSRIEXPERIMENTAL -
Interventions
NameTypeDescription
RG1068 (synthetic human secretin)DRUGSingle-dose, IV infusion
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * History of pancreatitis * Medically stable * Able to give informed consent Exclusion Criteria: * Prior history of pancreatic resection * Prior history of pancreatic duct drainage procedure * Presence of a pancreatic stent * Unstable cardiovascular disease * Any contraindicat...

Countries:United States
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Competitive Landscape -Pancreatitis 3 trials
CompanyTickerTrialsLead PhaseDrugs
CytoSorbents CorporationCTSO1 - Undisclosed
Azienda Ospedaliera Universitaria Integrata VeronaVRNA1 - Undisclosed
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