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Pinaverium Bromide in Post-cholecystectomy Sphincter of Oddi Dysfunction

NCT02833103 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2016-07-14

No results posted yet for this study

Summary

Sphincter of Oddi dysfunction (SOD) refers to biliary kinetic abnormality of the sphincter of Oddi (SO), often accompanied by pain, hepatic and pancreatic enzyme elevation, common bile duct (CBD) dilation or onset of pancreatitis. Pain caused by SOD affects the quality of life (QoL).The primary objective of this trial is to evaluate the efficacy of relieving abdominal pain of Pinaverium Bromide in medication therapy for patients with post-cholecystectomy SOD.

Conditions

  • Sphincter of Oddi Dysfunction

Interventions

DRUG

Danshu Capsules

Danshu Capsules (0.9g potid/day) for three months by oral

DRUG

Pinaverium Bromide

Pinaverium Bromide (100mg potid/day) for three months by oral

Sponsors & Collaborators

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

  • Zhaohui Tang, MD,PhD · Xinhua Hospital,School of Medicine,Shanghai Jiao Tong University

  • Zhiwei Quan, MD,PhD · Xinhua Hospital,School of Medicine,Shanghai Jiao Tong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2018-02-28
Completion
2018-02-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02833103 on ClinicalTrials.gov