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Bupivicaine alone

Phase 3

Chronic Pancreatitis | Small molecule | Gastrointestinal |Community Health Systems, Inc.|Last Updated: Jun 14, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

Bupivicaine alone · 1 trial · 1 indication

Phase 3 1
NCT00658736Efficacy of EUS-guided Celiac Plexus Blockade in Chronic PancreatitisChronic Pancreatitis
COMPLETED40 Analytics
PHASE3COMPLETED
Efficacy of EUS-guided Celiac Plexus Blockade in Chronic Pancreatitis
Chronic PancreatitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in Pain Disability Index
1 month after block

The Pain Disability Index (PDI) measures patients' responses of the extent to which pain limits their abilities to carry out everyday tasks. The index is scored from 0 (no limitation) to 70 (severe limitation). A decrease in score of 10 points or more is regarded as indicating significant improvement in the ability to carry out daily activities.

Secondary Endpoints

Change From Baseline in Quality of Life Score at 1 Month - SF12 Physical Component
1 month
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALEUS guided celiac block with bupivicaine and triamcinolone. Patient will undergo endoscopic ultrasound and celiac plexus blockade using an EUS needle inserted into the celiac plexus. 20 cc of injectate will be administered.
2PLACEBO_COMPARATOREUS guided celiac block with bupivicaine only. Patient will undergo endoscopic ultrasound and celiac plexus blockade using an EUS needle inserted into the celiac plexus. 20 cc of injectate will be administered.

Interventions

NameTypeDescription
TriamcinoloneDRUGInjection of bupivacaine and triamcinolone
Bupivicaine aloneDRUGInjection of bupivacaine
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Eligibility Criteria

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

Inclusion criteria include: * Age \>18 yrs * Ability for informed consent * Chronic pancreatic-type abdominal pain (type B) (11). Exclusion criteria include: * Pregnancy * Malignancy * Recent acute pancreatitis (within 2 months) * Elevated INR (\>1.5) or low platelet count (\<75 cells/mm3) * Alle...

Countries:United States
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Frequently asked questions about Bupivicaine alone

What is Bupivicaine alone used for in chronic pancreatitis?

Bupivicaine alone is being studied for the treatment of chronic pancreatitis. It is administered via endoscopic ultrasound-guided celiac plexus blockade to manage pain associated with this condition. The drug is in Phase 3 clinical development and is being evaluated by Community Health Systems, Inc.

What does Bupivicaine alone target?

Bupivicaine alone is a small molecule that works as a local anesthetic. It blocks nerve signals in the celiac plexus, a network of nerves in the abdomen, to relieve pain in patients with chronic pancreatitis. This mechanism is being tested in a Phase 3 clinical trial.

Who makes Bupivicaine alone?

Bupivicaine alone is being developed by Community Health Systems, Inc., a company traded on the New York Stock Exchange under the ticker symbol CYH. The company is conducting a Phase 3 clinical trial to evaluate the drug for chronic pancreatitis.

What phase is Bupivicaine alone in?

Bupivicaine alone is in Phase 3 clinical development for chronic pancreatitis. It is an investigational drug and has not been approved by the FDA. The Phase 3 trial has been completed, with results expected to inform further development.

What clinical trials is Bupivicaine alone in?

Bupivicaine alone is associated with one completed Phase 3 clinical trial, NCT00658736, titled 'Efficacy of EUS-guided Celiac Plexus Blockade in Chronic Pancreatitis.' This randomized, double-blind, placebo-controlled trial enrolled 40 participants in the United States and evaluated the drug's efficacy in chronic pancreatitis.

Is Bupivicaine alone the same as bupivacaine?

Bupivicaine alone is a form of bupivacaine, a local anesthetic. In the context of this clinical trial, it is used as a single agent for celiac plexus blockade in chronic pancreatitis. The drug is being studied as a standalone treatment, without combination with other agents.