Drotaverine Hydrochloride Versus Hyoscine-N-butylbromide for Duodenal Antimotility During Endoscopic Retrograde Cholangiopancreatography (ERCP)
1 other identifier
interventional
650
1 country
4
Brief Summary
The aim of the present study was to evaluate the use of drotaverine hydrochloride versus hyoscine-N-butylbromide in reducing duodenal motility during diagnostic and therapeutic ERCP.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2008
Shorter than P25 for phase_3
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 6, 2008
CompletedFirst Posted
Study publicly available on registry
August 8, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedResults Posted
Study results publicly available
December 23, 2009
CompletedSeptember 8, 2010
November 1, 2009
7 months
August 6, 2008
September 14, 2009
August 31, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Grades of the Number of Duodenal Contractions
a duodenal motility grade was determined as follows: 0 = no motility; 1 = less than five contractions/minute; 2 = 5 to 10/minute; 3 = 11 to 15/minute; 4 = continuous.
Intra-procedure
Secondary Outcomes (4)
Cannulation Time
Intra-procedure
Percentage of Successful Selective Cannulation
Intra-procedure
Frequency of Post-ERCP Complications
48 hours after ERCP
Side Effects
Intra-procedure and 24 hours after ERCP
Study Arms (2)
1
EXPERIMENTALDrotaverine hydrochloride
2
ACTIVE COMPARATORHyoscine-N-butylbromide
Interventions
Drotaverine hydrochloride 40mg was administered intravenously 15 minutes before ERCP
Hyoscine-N-butylbromide 20mg was administered intravenously 15 minutes before ERCP.
Eligibility Criteria
You may qualify if:
- All patients undergoing ERCP above the age of 18 years
You may not qualify if:
- Patient with Billroth II gastrectomy
- Known previous sphincterotomy
- Active acute pancreatitis before ERCP
- Ongoing acute cholangitis before ERCP
- Hypotension (systolic blood pressure \< 100 mmHg)
- Second-degree and third-degree atrioventricular block
- Heart failure
- Glaucoma
- Obstructive uropathy
- Impaired renal function (serum creatinine \> 133μmol/L)
- Pregnant or breastfeeding women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Fujian Provincial Hospital
Fuzhou, China
The First People's Hospital of Hangzhou
Hangzhou, China
Heilongjiang Provincial Hospital
Harbin, China
Changhai Hospital, Second Military Medical University
Shanghai, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Zhaoshen Li M.D.
- Organization
- Changhai Hospital, Second Military Medical University, Shanghai, China
Study Officials
- PRINCIPAL INVESTIGATOR
Zhaoshen Li, MD
Changhai Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 6, 2008
First Posted
August 8, 2008
Study Start
August 1, 2008
Primary Completion
March 1, 2009
Study Completion
July 1, 2009
Last Updated
September 8, 2010
Results First Posted
December 23, 2009
Record last verified: 2009-11