NCT02882451

Brief Summary

Pinaverium bromide can be used to treat symptoms related to irritable bowel syndrome (IBS) and functional disorders of the biliary tract. In this study, pinaverium bromide was compared with Vitamin C for the facilitation of bile duct and pancreatic duct cannulation in patients. The primary outcome was successful deep bile duct cannulation and pancreatic duct canulation. The second outcome was the major papillary orifice,bile juice flow from the papilla, time to achieve deep bile duct cannulation, fluoroscopy time for deep bile duct cannulation,the appearance of the major and minor papillary orifice, pancreatic juice flow from the papilla, time to achieve deep pancreatic duct cannulation, and fluoroscopy time for deep pancreatic duct cannulation in the pinaverium bromide group versus Vitamin C group.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 29, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

June 12, 2017

Status Verified

June 1, 2017

Enrollment Period

1.1 years

First QC Date

July 22, 2016

Last Update Submit

June 9, 2017

Conditions

Bile Duct Diseases

Keywords

bile ductendoscopic retrograde cholangiopancreatographypinaverium bromide

Outcome Measures

Primary Outcomes (1)

  • cannulation time for deep bile duct cannulation and pancreatic duct cannulation

    2 days

Secondary Outcomes (2)

  • bile juice flow from the major papilla and pancreatic juice flow from the major papilla

    2 days

  • appearance of the major papillary orifice

    2 days

Study Arms (2)

pinaverium bromide

EXPERIMENTAL

take 50 mg pinaverium bromide three times a day 1 days before and then 100 mg 1 hour before the examination orally

Dietary Supplement: pinaverium bromide

Vitamin C

PLACEBO COMPARATOR

take 50 mg Vitamin C three times a day 1 days before and then 100 mg 1 hour before the examination orally

Dietary Supplement: Vitamin C

Interventions

pinaverium bromideDIETARY_SUPPLEMENT
pinaverium bromide
Vitamin CDIETARY_SUPPLEMENT
Vitamin C

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • those with intact native papilla,
  • who underwent endoscopic retrograde choledochopancreatography for bile duct,
  • age≥18 years, ≤80years, and
  • agreement to participate in the study.

You may not qualify if:

  • a previous sphincterotomy,
  • previous attempted or unsuccessful endoscopic retrograde choledochopancreatography with papillary manipulation,
  • indwelling biliary or pancreatic stent(s),
  • active acute pancreatitis,
  • active acute pancreatitis
  • altered/postsurgical anatomy,
  • history of gastroparesis,
  • endoscopic retrograde choledochopancreatography for sphincter of Oddi's sphincter(SO) manometry,
  • known tumor of the major duodenal papilla, and
  • patients with any medication probably affecting SO motility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhai Hospital, Second Military Medical University

Shanghai, 200433, China

RECRUITING

MeSH Terms

Conditions

Bile Duct Diseases

Interventions

pinaveriumAscorbic Acid

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Central Study Contacts

Shu-Ling Wang, M.D

CONTACT

021-81873241wangshuling0000@126.com

Yu Bai, M.D

CONTACT

021-81873241baiyu1998@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Digestive Endoscopy Center

Study Record Dates

First Submitted

July 22, 2016

First Posted

August 29, 2016

Study Start

July 1, 2016

Primary Completion

August 1, 2017

Study Completion

October 1, 2017

Last Updated

June 12, 2017

Record last verified: 2017-06

Locations

CN(1)