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

This study has been completed.
Sponsor:
Information provided by:
Changhai Hospital
ClinicalTrials.gov Identifier:
NCT00731198
First received: August 6, 2008
Last updated: August 31, 2010
Last verified: November 2009
Results First Received: September 14, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Prevention
Conditions: ERCP
Pancreatic Diseases
Bile Duct Diseases
Interventions: Drug: Drotaverine hydrochloride
Drug: Hyoscine-N-butylbromide

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Experimental Drotaverine hydrochloride
Active Comparator Hyoscine-N-butylbromide

Participant Flow:   Overall Study
    Experimental   Active Comparator
STARTED   325   325 
COMPLETED   319   319 
NOT COMPLETED   6   6 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Experimental Drotaverine hydrochloride
Active Comparator Hyoscine-N-butylbromide
Total Total of all reporting groups

Baseline Measures
   Experimental   Active Comparator   Total 
Overall Participants Analyzed 
[Units: Participants]
 325   325   650 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   205   197   402 
>=65 years   120   128   248 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.98  (15.75)   59.20  (16.14)   58.09  (15.97) 
Gender 
[Units: Participants]
     
Female   139   173   312 
Male   186   152   338 
Region of Enrollment 
[Units: Participants]
     
China   325   325   650 


  Outcome Measures

1.  Primary:   The Grades of the Number of Duodenal Contractions   [ Time Frame: Intra-procedure ]

2.  Secondary:   Cannulation Time   [ Time Frame: Intra-procedure ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Percentage of Successful Selective Cannulation   [ Time Frame: Intra-procedure ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Frequency of Post-ERCP Complications   [ Time Frame: 48 hours after ERCP ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

5.  Secondary:   Side Effects   [ Time Frame: Intra-procedure and 24 hours after ERCP ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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:  
Name/Title: Zhaoshen Li M.D.
Organization: Changhai Hospital, Second Military Medical University, Shanghai, China
phone: 86-21-81873271
e-mail: zhaoshenlismmu@gmail.com



Responsible Party: Zhaoshen Li, Changhai Hospital, Second Military Medical University
ClinicalTrials.gov Identifier: NCT00731198     History of Changes
Other Study ID Numbers: Changhai-080615
Study First Received: August 6, 2008
Results First Received: September 14, 2009
Last Updated: August 31, 2010
Health Authority: China: Food and Drug Administration