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

History of Changes

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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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Reporting Groups

	Description
Experimental	Drotaverine hydrochloride
Active Comparator	Hyoscine-N-butylbromide
Total	Total of all reporting groups

Baseline Measures

	Experimental	Active Comparator	Total
Number of Participants [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 ]

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2. Secondary:

Cannulation Time [ Time Frame: Intra-procedure ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

3. Secondary:

Percentage of Successful Selective Cannulation [ Time Frame: Intra-procedure ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

4. Secondary:

Frequency of Post-ERCP Complications [ Time Frame: 48 hours after ERCP ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

5. Secondary:

Side Effects [ Time Frame: Intra-procedure and 24 hours after ERCP ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

Serious Adverse Events

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Other Adverse Events

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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.

Limitations and Caveats

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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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

No publications provided

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

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