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Drotaverine Hydrochloride Versus Hyoscine-N-butylbromide for Duodenal Antimotility During Endoscopic Retrograde Cholangiopancreatography (ERCP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00731198
Recruitment Status : Completed
First Posted : August 8, 2008
Results First Posted : December 23, 2009
Last Update Posted : September 8, 2010
Sponsor:
Information provided by:
Changhai Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Conditions ERCP
Pancreatic Diseases
Bile Duct Diseases
Interventions Drug: Drotaverine hydrochloride
Drug: Hyoscine-N-butylbromide
Enrollment 650
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Experimental Active Comparator
Hide Arm/Group Description Drotaverine hydrochloride Hyoscine-N-butylbromide
Period Title: Overall Study
Started 325 325
Completed 319 319
Not Completed 6 6
Arm/Group Title Experimental Active Comparator Total
Hide Arm/Group Description Drotaverine hydrochloride Hyoscine-N-butylbromide Total of all reporting groups
Overall Number of Baseline Participants 325 325 650
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 325 participants 325 participants 650 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
205
  63.1%
197
  60.6%
402
  61.8%
>=65 years
120
  36.9%
128
  39.4%
248
  38.2%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 325 participants 325 participants 650 participants
56.98  (15.75) 59.20  (16.14) 58.09  (15.97)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 325 participants 325 participants 650 participants
Female
139
  42.8%
173
  53.2%
312
  48.0%
Male
186
  57.2%
152
  46.8%
338
  52.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 325 participants 325 participants 650 participants
325 325 650
1.Primary Outcome
Title The Grades of the Number of Duodenal Contractions
Hide Description 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.
Time Frame Intra-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Experimental Active Comparator
Hide Arm/Group Description:
Drotaverine hydrochloride
Hyoscine-N-butylbromide
Overall Number of Participants Analyzed 319 319
Mean (Standard Deviation)
Unit of Measure: scores on a scale
1.13  (0.89) 1.17  (0.82)
2.Secondary Outcome
Title Cannulation Time
Hide Description [Not Specified]
Time Frame Intra-procedure
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Percentage of Successful Selective Cannulation
Hide Description [Not Specified]
Time Frame Intra-procedure
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Frequency of Post-ERCP Complications
Hide Description [Not Specified]
Time Frame 48 hours after ERCP
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Side Effects
Hide Description [Not Specified]
Time Frame Intra-procedure and 24 hours after ERCP
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Experimental Active Comparator
Hide Arm/Group Description Drotaverine hydrochloride Hyoscine-N-butylbromide
All-Cause Mortality
Experimental Active Comparator
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Experimental Active Comparator
Affected / at Risk (%) Affected / at Risk (%)
Total   0/319 (0.00%)   0/319 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Experimental Active Comparator
Affected / at Risk (%) Affected / at Risk (%)
Total   0/319 (0.00%)   0/319 (0.00%) 
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Zhaoshen Li M.D.
Organization: Changhai Hospital, Second Military Medical University, Shanghai, China
Phone: 86-21-81873271
EMail: zhaoshenlismmu@gmail.com
Layout table for additonal information
Responsible Party: Zhaoshen Li, Changhai Hospital, Second Military Medical University
ClinicalTrials.gov Identifier: NCT00731198    
Other Study ID Numbers: Changhai-080615
First Submitted: August 6, 2008
First Posted: August 8, 2008
Results First Submitted: September 14, 2009
Results First Posted: December 23, 2009
Last Update Posted: September 8, 2010