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A Double-blind Study to Determine if Intraduodenal Indomethacin Can Decrease the Incidence of Post-ERCP Pancreatitis

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ClinicalTrials.gov Identifier: NCT00727740
Recruitment Status : Completed
First Posted : August 4, 2008
Results First Posted : January 18, 2017
Last Update Posted : January 18, 2017
Sponsor:
Information provided by (Responsible Party):
Yale University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Pancreatitis
Interventions Drug: Indomethacin
Drug: Placebo suspension
Enrollment 117
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 1- Indomethacin 2- Placebo
Hide Arm/Group Description

Indomethacin liquid suspension 100 mg (25 mg/5ml) which is 20 cc of suspension instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline.

Indomethacin: Indomethacin 100 mg liquid suspension (25 mg/5 ml) which is 20 cc of suspension is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline.

Placebo suspension in the same volume (20 cc) which is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. The placebo suspension is also flushed with 5 cc of normal saline.

Placebo suspension: A placebo suspension which is made by the Investigational Drug Service (IDS) by adding the appropriate dye coloring to normal saline so that the appearance is identical to the indomethacin suspension. The placebo solution is also instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the placebo suspension, the catheter is flushed with 5 cc of normal saline.

Period Title: Overall Study
Started 56 61
Completed 56 61
Not Completed 0 0
Arm/Group Title 1- Indomethacin 2- Placebo Total
Hide Arm/Group Description

Indomethacin liquid suspension 100 mg (25 mg/5ml) which is 20 cc of suspension instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline.

Indomethacin: Indomethacin 100 mg liquid suspension (25 mg/5 ml) which is 20 cc of suspension is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline.

Placebo suspension in the same volume (20 cc) which is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. The placebo suspension is also flushed with 5 cc of normal saline.

Placebo suspension: A placebo suspension which is made by the Investigational Drug Service (IDS) by adding the appropriate dye coloring to normal saline so that the appearance is identical to the indomethacin suspension. The placebo solution is also instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the placebo suspension, the catheter is flushed with 5 cc of normal saline.

Total of all reporting groups
Overall Number of Baseline Participants 56 61 117
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 56 participants 61 participants 117 participants
54.2  (18.3) 56.6  (13.5) 55.4  (16.1)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 61 participants 117 participants
Female
22
  39.3%
24
  39.3%
46
  39.3%
Male
34
  60.7%
37
  60.7%
71
  60.7%
1.Primary Outcome
Title Reduction in Pancreatitis Rate
Hide Description Pancreatitis was operationally defined as post-ERCP pancreatitis (PEP). PEP was defined as abdominal pain with elevated serum amylase level (3 times above the upper limit of normal). The change in Pancreatitis rate calculated as the percentage of participants with pancreatitis at baseline minus percentage of participants with pancreatitis at 24 hours.
Time Frame 24 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1- Indomethacin 2- Placebo
Hide Arm/Group Description:

Indomethacin liquid suspension 100 mg (25 mg/5ml) which is 20 cc of suspension instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline.

Indomethacin: Indomethacin 100 mg liquid suspension (25 mg/5 ml) which is 20 cc of suspension is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline.

Placebo suspension in the same volume (20 cc) which is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. The placebo suspension is also flushed with 5 cc of normal saline.

Placebo suspension: A placebo suspension which is made by the Investigational Drug Service (IDS) by adding the appropriate dye coloring to normal saline so that the appearance is identical to the indomethacin suspension. The placebo solution is also instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the placebo suspension, the catheter is flushed with 5 cc of normal saline.

Overall Number of Participants Analyzed 56 61
Measure Type: Number
Unit of Measure: percentage of participants with PEP
16.1 4.9
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1- Indomethacin 2- Placebo
Hide Arm/Group Description

Indomethacin liquid suspension 100 mg (25 mg/5ml) which is 20 cc of suspension instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline.

Indomethacin: Indomethacin 100 mg liquid suspension (25 mg/5 ml) which is 20 cc of suspension is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline.

Placebo suspension in the same volume (20 cc) which is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. The placebo suspension is also flushed with 5 cc of normal saline.

Placebo suspension: A placebo suspension which is made by the Investigational Drug Service (IDS) by adding the appropriate dye coloring to normal saline so that the appearance is identical to the indomethacin suspension. The placebo solution is also instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the placebo suspension, the catheter is flushed with 5 cc of normal saline.

All-Cause Mortality
1- Indomethacin 2- Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
1- Indomethacin 2- Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/56 (0.00%)   0/61 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
1- Indomethacin 2- Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/56 (0.00%)   0/61 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Priya Jamidar, MD
Organization: Yale University School of Medicine
Phone: 203-785-6228
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00727740     History of Changes
Other Study ID Numbers: 0502027420
First Submitted: July 31, 2008
First Posted: August 4, 2008
Results First Submitted: August 24, 2016
Results First Posted: January 18, 2017
Last Update Posted: January 18, 2017