Sphincter of Oddi DysfunctionPhase 4NCT02833103
Pinaverium Bromide in Post-cholecystectomy Sphincter of Oddi Dysfunction
A Phase 4 study testing Danshu Capsules and Pinaverium Bromide in people with Sphincter of Oddi Dysfunction, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Sphincter of Oddi Dysfunction
- What is being tested?
- Danshu Capsules and Pinaverium Bromide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteChina
- Study dates
- Jul 2016to Feb 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhang Yong
Shanghai, Shanghai Municipality, 200092
Yong Zhang, MD,PhD, +86 21 25078999-7905
Yong Zhang, MD,PhD
About this study
Official title: Application of Pinaverium Bromide in the Treatment of Patients With Post-cholecystectomy Sphincter of Oddi Dysfunction (SOD): A Randomized, Controlled and Multicenter Clinical Study
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.
Read the detailed description
1.1 Background (I)
1.1.1 10%~50% of the patients who previously underwent cholecystectomy experience recurrent abdominal pain with or without diarrhea, abdominal distention, enzymatic changes, etc., and sphincter of Oddi dysfunction (SOD) accounts for about 13% of such cases;
1.1.2 Sphincter of Oddi dysfunction (SOD):
- It 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).
1.1.3 The diagnosis of SOD is still being disputed, and there has been no optimal solution so far.
- The diagnosis of SOD is largely based on clinical judgment
- The gold standards ERCP and SOM are invasive diagnostic criteria
1.2 Background (II)
1.2.1 If biliary-type abdominal pain after cholecystectomy is considered as SOD, most of the patients are classified as SOD II and SOD III according to Rome III Criteria-modified.
Biliary SOD Type I: moderate or severe biliary-type abdominal pain; transient ALT / AST/ALP elevation > 2ULN; CBD dilation > 8mm as evidenced by ultrasound or other non-invasive examination Type II: biliary-type abdominal pain; One or two of above items Type III:only biliary-type abdominal pain
1.3 Background (III)
1.3.1 Treatment of SOD is being disputed: currently, the main method is to relax sphincter of Oddi (SO).
- Medications: antispasmodic drugs, nitrates, calcium ion antagonists, modulators of gastrointestinal (GI) motility
- EST(endoscopic sphincterotomy): postoperative complications and mortality
1.3.2 EST is not well effective in the treatment of SOD type II and type III, which are mostly caused by functional abnormalities
-ASGE guideline 2015 points out that EST is not recommended for patients with SOD type III. Endoscopic stents are not recommended, either.
1.3.3 Danshu Capsules: 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.
1.3.4 Pinaverium Bromide: able to improve the spasms of SO; literature showed that it treated biliary disorders effectively.·10%~50% of the patients who previously underwent cholecystectomy experience recurrent abdominal pain with or without diarrhea, abdominal distention, enzymatic changes, etc., and sphincter of Oddi dysfunction (SOD) accounts for about 13% of such cases.
- Conditions
- Sphincter of Oddi Dysfunction
- Being tested
- Danshu Capsules, Pinaverium Bromide
- Keywords
- Pinaverium Bromide, cholecystectomy, Sphincter of Oddi Dysfunction
- Medical subject headings
- Sphincter of Oddi Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Danshu CapsulesDrug
Also called Danshu softgel Capsules
Danshu Capsules (0.9g potid/day) for three months by oral
Pinaverium BromideDrug
Also called Dicetel
Pinaverium Bromide (100mg potid/day) for three months by oral
| Study group | Role | What they receive |
|---|---|---|
| Pinaverium Bromide group | Experimental | Able to improve the spasms of SO; literature showed that it treated biliary disorders effectively. Receives: 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. Receives: Drug: Danshu Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Changes in the CBD diameter measured by ultrasound B
- Each patient is required to abstain from eating for 12 hours and then takes a measurement of the CBD diameter by ultrasound B the next morning
- The measurement takes places once a month, four times totally (baseline / 4w after treatment / 8w after treatment / 12w after treatment)
Measured: 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
- Changes in hepatic enzyme levels (ALT, AST and ALP)
- The measurement takes place once a month, four times totally (baseline / 4w after treatment / 8w after treatment / 12w after treatment)
Measured: 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
The number of patients presenting the symptoms of diarrhea will be calculated at the time of enrollment (baseline) and 3 months after treatment respectively.
Measured: From Baseline to 3 Months After Medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionFeb 2018 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Sphincter of Oddi DysfunctionStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaohui Tang, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Zhaohui Tang, MD,PhD, Principal investigator, Xinhua Hospital,School of Medicine,Shanghai Jiao Tong UniversityZhiwei Quan, MD,PhD, Study chair, Xinhua Hospital,School of Medicine,Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02833103
- Sponsor's protocol ID
- XH-16-015
- Status last verified
- Jul 2016
- First submitted
- 4 Jul 2016
- Last updated
- 14 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 24867013Vitton 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.
PubMed 22529689Okoro 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.
PubMed 18577477Kalaitzakis 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.
PubMed 20969779Behar 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.
PubMed 16678563Drossman 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.
PubMed 16678553Hernando 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.
PubMed 20665015
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Pinaverium Bromide in the Treatment of Patients With Post-cholecystectomy Sphincter of Oddi Dysfunction (SOD): A Randomized, Controlled and Multicenter Clinical Study
- ClinicalTrials.gov ID
- NCT02833103
- Acronym / sponsor ID
- XH-16-015
- Conditions
- Sphincter of Oddi Dysfunction
- Keywords
- Pinaverium Bromide, cholecystectomy, Sphincter of Oddi Dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 14 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
1.1 Background (I)
1.1.1 10%~50% of the patients who previously underwent cholecystectomy experience recurrent abdominal pain with or without diarrhea, abdominal distention, enzymatic changes, etc., and sphincter of Oddi dysfunction (SOD) accounts for about 13% of such cases;
1.1.2 Sphincter of Oddi dysfunction (SOD):
- It 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).
1.1.3 The diagnosis of SOD is still being disputed, and there has been no optimal solution so far.
- The diagnosis of SOD is largely based on clinical judgment
- The gold standards ERCP and SOM are invasive diagnostic criteria
1.2 Background (II)
1.2.1 If biliary-type abdominal pain after cholecystectomy is considered as SOD, most of the patients are classified as SOD II and SOD III according to Rome III Criteria-modified.
Biliary SOD Type I: moderate or severe biliary-type abdominal pain; transient ALT / AST/ALP elevation > 2ULN; CBD dilation > 8mm as evidenced by ultrasound or other non-invasive examination Type II: biliary-type abdominal pain; One or two of above items Type III:only biliary-type abdominal pain
1.3 Background (III)
1.3.1 Treatment of SOD is being disputed: currently, the main method is to relax sphincter of Oddi (SO).
- Medications: antispasmodic drugs, nitrates, calcium ion antagonists, modulators of gastrointestinal (GI) motility
- EST(endoscopic sphincterotomy): postoperative complications and mortality
1.3.2 EST is not well effective in the treatment of SOD type II and type III, which are mostly caused by functional abnormalities
-ASGE guideline 2015 points out that EST is not recommended for patients with SOD type III. Endoscopic stents are not recommended, either.
1.3.3 Danshu Capsules: 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.
1.3.4 Pinaverium Bromide: able to improve the spasms of SO; literature showed that it treated biliary disorders effectively.·10%~50% of the patients who previously underwent cholecystectomy experience recurrent abdominal pain with or without diarrhea, abdominal distention, enzymatic changes, etc., and sphincter of Oddi dysfunction (SOD) accounts for about 13% of such cases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pinaverium Bromide group | Experimental | Drug: Pinaverium BromideAble to improve the spasms of SO; literature showed that it treated biliary disorders effectively. |
| Danshu group | Active comparator | Drug: Danshu CapsulesContains 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. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Danshu CapsulesAlso: Danshu softgel CapsulesDanshu Capsules (0.9g potid/day) for three months by oral | Drug | Danshu group |
| Pinaverium BromideAlso: DicetelPinaverium Bromide (100mg potid/day) for three months by oral | Drug | Pinaverium Bromide group |
Primary outcome
Efficacy Evaluation of Reduction in Abdominal Pain Scores，Change From Baseline to 3 Months After Medication
Time frame: 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
3 secondary outcomes
Changes in the Common Bile Duct (CBD) Diameter Measured by Ultrasound B Once a Month
Time frame: 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
Time frame: 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
Time frame: From Baseline to 3 Months After Medication
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2016.
- Background: PubMed 24867013Cotton 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.
- Background: PubMed 22529689Vitton 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.
- Background: PubMed 18577477Okoro 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.
- Background: PubMed 20969779Kalaitzakis 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.
- Background: PubMed 16678563Behar 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.
- Background: PubMed 16678553Drossman 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.
- Background: PubMed 20665015Hernando 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhaohui Tang, MD,PhD principal investigator
Xinhua Hospital,School of Medicine,Shanghai Jiao Tong University
Zhiwei Quan, MD,PhD study chair
Xinhua Hospital,School of Medicine,Shanghai Jiao Tong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Danshu Capsules and Pinaverium Bromide in people with Sphincter of Oddi Dysfunction, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhaohui Tang, MD,PhD (+86 021 25078999-7905, tangzhaohui@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy Evaluation of Reduction in Abdominal Pain Scores，Change From Baseline to 3 Months After Medication (time frame: Change From Baseline to 3 Months After Medication). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02833103, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2016.