Pinaverium Bromide in Post-cholecystectomy Sphincter of Oddi Dysfunction

NCT02833103 | Unknown Phase 4

• 1 other identifier: XH-16-015
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pinaverium Bromide; cholecystectomy; Sphincter of Oddi Dysfunction

Outcome Measures

Primary Outcomes (1)

• Efficacy Evaluation of Reduction in Abdominal Pain Scores，Change From Baseline to 3 Months After Medication

  abdominal pain scores (baseline vs. 3 months after treatment) * Abdominal pain score based on main symptom: Degree of pain in point（0 - no pain \[0 point\]；1\~3 - mild pain \[1 point\]；4\~6 moderate pain \[2 point\]\]；7\~10 - severe pain \[3 point\]）、Frequency in times/week (No episodes\[0 point\]；1 time/week\[1 point\]；2 times/week\[2 point\]; 3 times/week\[3 point\])、Duration in days/week(No episodes\[0 point\]；\< 1 day/week\[1 point\]；1-2days/week\[2 points\]；≥ 3days/week\[3 points\]) * The sum of the scores for the above three items is the total score for abdominal pain. * Efficacy evaluation: reduction in abdominal pain score, as compared with the baseline * = 100%: complete remission (CR)；60%\~99%: significant remission (SR)；30% \~ 59%: partial remission (PR)；0% \~ 29%: no response (NR) * Treatment response = CR + SR * Treatment response rate = (CR + SR) / the total number of patients

  Change From Baseline to 3 Months After Medication

Secondary Outcomes (3)

• Changes in the Common Bile Duct (CBD) Diameter Measured by Ultrasound B Once a Month

  Once a Month, Four Times Totally (baseline / 4w after treatment / 8w after treatment / 12w after treatment)

• Efficacy of Lowering Liver Enzymes as Assessed by Laboratory Test Once a Month

  Once a Month, Four Times Totally (baseline / 4w after treatment / 8w after treatment / 12w after treatment)

• Number of Participants With Treatment-Related Diarrhea,Change From Baseline to 3 Months After Medication

  From Baseline to 3 Months After Medication

Other Outcomes (1)

• Number of Participants With Treatment-Related Adverse Events as Assessed by Researchers or Doctors Through Study Completion

  Through Study Completion, An Average of 1 Year

Study Arms (2)

Pinaverium Bromide group

EXPERIMENTAL

Able to improve the spasms of SO; literature showed that it treated biliary disorders effectively.

Drug: Pinaverium Bromide

Danshu group

ACTIVE COMPARATOR

Contains the active pharmaceutical ingredient (API) and has the effects of fighting infection, alleviating pain, promoting bile secretion and lifting muscle spasms; literature showed that Danshu Capsules effectively improved the symptoms of biliary disorders, such as pain, nausea and abdominal distension.

Drug: Danshu Capsules

Interventions

Danshu Capsules DRUG

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

Also known as: Danshu softgel Capsules

Danshu group

Pinaverium Bromide DRUG

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

Also known as: Dicetel

Pinaverium Bromide group

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chief complaint of upper right abdominal pain following LC (within 2 weeks to 6 months) at a hospital visit, but not a pain caused by surgical incision, lasting 3 to 5 minutes each time, without a history of other biliary tract operation
• No presence of intestinal obstruction as evidenced by plain abdominal X-ray, with peptic ulcer and duodenal diverticulum ruled out through barium meal examination or gastroscopy
• No other obvious abnormalities as evidenced by abdominal ultrasound B and MRCP, except for bile duct dilation
• Patients with biliary-type sphincter of Oddi dysfunction (SOD) who are classified as SOD type II (biliary-type abdominal pain accompanied by hepatic enzyme elevation or common bile duct (CBD) dilation) and SOD type III (only biliary-type abdominal pain) according to Geenen-Hogan classification criteria

You may not qualify if:

• Postoperative biliary calculi, benign biliary stenosis, bile duct infection, overlong residual cystic duct (\> 0.5cm), biliary tumors, etc.
• Peptic ulcer, duodenal diverticulum
• Pancreatitis, pancreatic-type SOD
• Adhesive intestinal obstruction
• Postoperative irritable bowel syndrome (IBS)
• A history of abdominal operation or other surgery
• Pregnant and lactating women
• Use of other drugs from one week after LC to enrollment, including antispasmodic drugs, analgesics, choleretic agents, calcium ion antagonists and GI motility drugs
• A history of allergy to Pinaverium Bromide / Danshu Tablets

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Zhang Yong

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

Related Publications (7)

• Cotton PB, Durkalski V, Romagnuolo J, Pauls Q, Fogel E, Tarnasky P, Aliperti G, Freeman M, Kozarek R, Jamidar P, Wilcox M, Serrano J, Brawman-Mintzer O, Elta G, Mauldin P, Thornhill A, Hawes R, Wood-Williams A, Orrell K, Drossman D, Robuck P. Effect of endoscopic sphincterotomy for suspected sphincter of Oddi dysfunction on pain-related disability following cholecystectomy: the EPISOD randomized clinical trial. JAMA. 2014 May;311(20):2101-9. doi: 10.1001/jama.2014.5220.

  PMID: 24867013 BACKGROUND

• Vitton V, Ezzedine S, Gonzalez JM, Gasmi M, Grimaud JC, Barthet M. Medical treatment for sphincter of oddi dysfunction: can it replace endoscopic sphincterotomy? World J Gastroenterol. 2012 Apr 14;18(14):1610-5. doi: 10.3748/wjg.v18.i14.1610.

  PMID: 22529689 BACKGROUND

• Okoro N, Patel A, Goldstein M, Narahari N, Cai Q. Ursodeoxycholic acid treatment for patients with postcholecystectomy pain and bile microlithiasis. Gastrointest Endosc. 2008 Jul;68(1):69-74. doi: 10.1016/j.gie.2007.09.046.

  PMID: 18577477 BACKGROUND

• Kalaitzakis E, Ambrose T, Phillips-Hughes J, Collier J, Chapman RW. Management of patients with biliary sphincter of Oddi disorder without sphincter of Oddi manometry. BMC Gastroenterol. 2010 Oct 22;10:124. doi: 10.1186/1471-230X-10-124.

  PMID: 20969779 BACKGROUND

• Behar J, Corazziari E, Guelrud M, Hogan W, Sherman S, Toouli J. Functional gallbladder and sphincter of oddi disorders. Gastroenterology. 2006 Apr;130(5):1498-509. doi: 10.1053/j.gastro.2005.11.063.

  PMID: 16678563 BACKGROUND

• Drossman DA. The functional gastrointestinal disorders and the Rome III process. Gastroenterology. 2006 Apr;130(5):1377-90. doi: 10.1053/j.gastro.2006.03.008. No abstract available.

  PMID: 16678553 BACKGROUND

• Hernando N, Gisler SM, Reining SC, Deliot N, Capuano P, Biber J, Murer H. NaPi-IIa interacting proteins and regulation of renal reabsorption of phosphate. Urol Res. 2010 Aug;38(4):271-6. doi: 10.1007/s00240-010-0304-3. Epub 2010 Jul 28.

  PMID: 20665015 BACKGROUND

MeSH Terms

Conditions

Sphincter of Oddi Dysfunction

Interventions

pinaverium

Condition Hierarchy (Ancestors)

Biliary Dyskinesia; Common Bile Duct Diseases; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Zhaohui Tang, MD,PhD

  Xinhua Hospital,School of Medicine,Shanghai Jiao Tong University

  PRINCIPAL INVESTIGATOR

• Zhiwei Quan, MD,PhD

  Xinhua Hospital,School of Medicine,Shanghai Jiao Tong University

  STUDY CHAIR

Central Study Contacts

Zhaohui Tang, MD,PhD

CONTACT

+86 021 25078999-7905; tangzhaohui@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: the chief surgeon of the department of General Surgery

Study Record Dates

• First Submitted: July 4, 2016
• First Posted: July 14, 2016
• Study Start: July 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: July 14, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)