Efficacy Study of Glyceryl-Trinitrate Patch and Parecoxib (Valdecoxib) for the Prevention of Pancreatitis After Endoscopic Retrograde Cholangiopancreatography (ERCP)

This study has been terminated.
(Because one of the drugs Valdecoxib was withdrawn due to safety concerns.)
Sponsor:
Information provided by:
All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT00419549
First received: January 5, 2007
Last updated: January 28, 2009
Last verified: January 2009
  Purpose

ERCP is a diagnostic and therapeutic procedure that is required in patients with suspected common bile duct stone, malignant biliary obstruction, biliary fistula, etc. Pancreatitis may occur as a complication of this procedure after about 5-10% of the ERCP procedures. This complication manifests as persisting pain 24 hours or more after ERCP, along with raised levels of pancreatic enzymes in the blood. Most of the cases of post-ERCP pancreatitis are mild, but may be severe and lead to prolonged hospitalization a few patients. The occurrence of this complication is unpredictable. There have been a number of attempts to prevent this complication. These include giving certain drugs before ERCP e.g. octreotide, somatostatin, steroids, etc. However, these have not been successful. Recently, a study showed that application of glyceryl trinitrate patch on the skin before ERCP might reduce the incidence of post ERCP-pancreatitis. Another study showed that per rectal administration of diclofenac tablet after the ERCP procedure also reduced occurrence of post ERCP pancreatitis. Other experimental studies have shown that certain anti-inflammatory drugs like cox-2 inhibitors may also be effective.

The investigators want to study whether transdermal patch of glyceryl trinitrate or administration of injectable cox-2 inhibitor Valdecoxib (pro-drug Parecoxib) can prevent post-ERCP pancreatitis in our patients who undergo an ERCP.


Condition Intervention Phase
ERCP
Pancreatitis
Drug: Glyceryl - trinitrate
Drug: Valdecoxib
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Transdermal Glyceryl-Trinitrate and Parecoxib (Valdecoxib) for the Prevention of Post -ERCP Pancreatitis

Resource links provided by NLM:


Further study details as provided by All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:
  • Frequency of acute pancreatitis after ERCP [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency of pain [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Degree of hyper-amylasemia [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 371
Study Start Date: October 2003
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Valdecoxib
Drug: Valdecoxib
Single parenteral administration
Active Comparator: 2 Drug: Glyceryl - trinitrate
Transdermal Patch once only
No Intervention: 3

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients aged 18 years and above undergoing first ERCP procedure

Exclusion Criteria:

  • Active acute pancreatitis,
  • Lower end malignant bile duct block,
  • Patients undergoing repeat procedures,including those with previous sphincterotomy
  • Ongoing therapy with nitrates, calcium channel blockers, somatostatin or octreotide
  • Patients with bleeding diathesis.
  • Patients with chronic pancreatitis
  • Patients with cardiac comorbidity
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00419549

Locations
India
All India Institute of Medical Sciences
New Delhi, India
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Investigators
Study Director: Pramod K Garg, M.D., D.M. All India Institute of Medical Sciences, New Delhi
Principal Investigator: Vikram Bhatia, M.D., D.M. All India Institute of Medical Sciences, New Delhi
  More Information

Additional Information:
Publications:
Responsible Party: Pramod Kumar Garg, All India Institute of Medical Sciences
ClinicalTrials.gov Identifier: NCT00419549     History of Changes
Other Study ID Numbers: GE-ERCP-AP/2006
Study First Received: January 5, 2007
Last Updated: January 28, 2009
Health Authority: India: Ministry of Health

Keywords provided by All India Institute of Medical Sciences, New Delhi:
ERCP
Pancreatitis
Nitroglycerine
Valdecoxib

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases
Valdecoxib
Nitroglycerin
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents
Vasodilator Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 18, 2014