Trial Outcomes & Findings for Drotaverine Hydrochloride Versus Hyoscine-N-butylbromide for Duodenal Antimotility During Endoscopic Retrograde Cholangiopancreatography (ERCP) (NCT NCT00731198)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

650 participants

Primary outcome timeframe

Intra-procedure

Results posted on

2010-09-08

Participant Flow

Participant milestones

Participant milestones
Measure	Experimental Drotaverine hydrochloride	Active Comparator Hyoscine-N-butylbromide
Overall Study STARTED	325	325
Overall Study COMPLETED	319	319
Overall Study NOT COMPLETED	6	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental n=325 Participants Drotaverine hydrochloride	Active Comparator n=325 Participants Hyoscine-N-butylbromide	Total n=650 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	205 Participants n=5 Participants	197 Participants n=7 Participants	402 Participants n=5 Participants
Age, Categorical >=65 years	120 Participants n=5 Participants	128 Participants n=7 Participants	248 Participants n=5 Participants
Age Continuous	56.98 years STANDARD_DEVIATION 15.75 • n=5 Participants	59.20 years STANDARD_DEVIATION 16.14 • n=7 Participants	58.09 years STANDARD_DEVIATION 15.97 • n=5 Participants
Sex: Female, Male Female	139 Participants n=5 Participants	173 Participants n=7 Participants	312 Participants n=5 Participants
Sex: Female, Male Male	186 Participants n=5 Participants	152 Participants n=7 Participants	338 Participants n=5 Participants
Region of Enrollment China	325 participants n=5 Participants	325 participants n=7 Participants	650 participants n=5 Participants

PRIMARY outcome

Timeframe: Intra-procedure

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.

Outcome measures

Outcome measures
Measure	Experimental n=319 Participants Drotaverine hydrochloride	Active Comparator n=319 Participants Hyoscine-N-butylbromide
The Grades of the Number of Duodenal Contractions	1.13 scores on a scale Standard Deviation 0.89	1.17 scores on a scale Standard Deviation 0.82

SECONDARY outcome

Timeframe: Intra-procedure

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Intra-procedure

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 48 hours after ERCP

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Intra-procedure and 24 hours after ERCP

Outcome measures

Outcome data not reported

Adverse Events

Experimental

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Active Comparator

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Zhaoshen Li M.D.

Changhai Hospital, Second Military Medical University, Shanghai, China

Phone: 86-21-81873271

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place