Sphincter of Oddi DysfunctionPhase 3SODNCT00471315
Duloxetine in Patients With Suspected Functional Pancreatic/Biliary Pain (Sphincter of Oddi Dysfunction)
A Phase 3 study testing Duloxetine in people with Sphincter of Oddi Dysfunction, run by Medical University of South Carolina at 1 site in United States.
Trial summary
Open-label single center study of duloxetine in patients with SOD who have failed to respond to the standard treatments. This protocol is designed to explore the tolerability and efficacy of Duloxetine in the management of patients with known or suspected Sphincter of Oddi dysfunction (SOD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sphincter of Oddi Dysfunction
- What is being tested?
- Duloxetine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Mar 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients referred to MUSC pancreatico-biliary service for investigation/ mgt of functional upper abdominal pain symptoms;
- No clinically significant medical condition(s) as determined by the investigator;
- Symptom severity. At least 2 pain attacks in the previous month, with severity of at least 4/10 on the RAPID Start scale;
- Prior cholecystectomy;
- Age 18-65*;
- Functional pain characteristics as defined by Rome III Criteria;
Show all 11Show fewer
- Structural causes of pain excluded by standard imaging and laboratory investigations;
- No clinically significant ECG results as determined by the investigator;
- All patients will give verbal and written Informed consent;
- Female patients must use an acceptable form of contraception, or be 2 years postmenopausal or surgically sterile*; and
- Geographically accessible for follow-up visits
Who cannot join
- History of/current psychosis, bipolar disorder, suicidal ideation or judged to be a significant suicide risk, as determined via baseline psychiatric assessment utilizing the MINI interview
- History of alcohol or any psychoactive substance abuse or dependence within the past 6 months, as determined via baseline psychiatric assessment utilizing the MINI interview
- Abnormal Liver Function Tests (> 3 x ULN)
- Known hypersensitivity to Duloxetine or any of the inactive ingredients
- Treatment with a monoamine oxidase inhibitor (MAOI) within 14 days of randomization or potential need to use an MAOI during study or within 5 days of discontinuation of study drug
- Treatment with fluoxetine (deleted MAOI) within 30 days of medication start date
Show all 13Show fewer
- Treatment with excluded medications within 7 days prior to study medication start-up date
- Serious medical illness, including any cardiovascular, hepatic, renal respiratory hematologic, endocrinologic or neurologic disease, or significant laboratory abnormality as judged by study physician/investigator.
- Uncontrolled narrow-angle glaucoma
- Acute liver injury (such as hepatitis) or severe cirrhosis
- Prior lack of tolerability to duloxetine
- Pregnancy and breastfeeding
- Participation in the study is approximately 4 months. There are 4 clinic visits and 2 telephone visits.
Trial locations and contacts
1 site in 1 country.
United States1 site
Digestive Disease Center, Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Pilot Study of the Efficacy and Tolerability of Duloxetine in Patients With Suspected Functional Pancreatic/Biliary Pain (Sphincter of Oddi Dysfunction).
Open-label single center study of duloxetine in patients with SOD who have failed to respond to the standard treatments.
This protocol is designed to explore the tolerability and efficacy of Duloxetine in the management of patients with known or suspected Sphincter of Oddi dysfunction (SOD).
Read the detailed description
SOD is a disorder involving the bile duct or pancreas causing a burning pain or cramping in the epigastric (upper stomach) area that can radiate (spread) to the back or under the right shoulder blade. This discomfort is thought to be caused by tightening of the Sphincter of Oddi, which is the muscle opening that controls the flow of bile and juices from the pancreas (enzymes) into the small intestine. It can also be caused by contractions of the common bile duct (the duct that allows bile from the liver into the small intestine).
The purpose of this research is to study how well a medication called Duloxetine works when used to treat pain associated with SOD. Duloxetine (also called Cymbalta) is a medication approved by the FDA for the treatment of depression and for the treatment of pain caused by nerve damage associated with diabetes. However, for the purposes of this research, Duloxetine is considered investigational (experimental) since it will test how well this medication works for the treatment of pain associated with SOD. (Cymbalta replaced with Duloxetine in remainder of consent as requested).
PRIMARY OBJECTIVE
● Treatment effect as measured by the global assessment of change (PGIC) after 3 months of treatment with duloxetine.
SECONDARY OBJECTIVES
- Toleration of the medication as measured by the duloxetine compliance rate;
- Safety as recorded by adverse events (AEs)
- Effect of treatment on pain reduction as measured by a pain burden assessment tool (RAPID 3 \& RAPID 1-Month);
- Effect of treatment on quality of life (QOL) as measured by the SF-36.
- Conditions
- Sphincter of Oddi Dysfunction
- Being tested
- Duloxetine
- Keywords
- SOD, Common Bile Duct Diseases, Sphincterotomy, Cholangiopancreatography, Endoscopic Retrograde
- Medical subject headings
- Sphincter of Oddi Dysfunction, Common Bile Duct Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuloxetineDrug
Also called Cymbalta
A preliminary, open-label single center study of duloxetine in patients with SOD
| Study group | Role | What they receive |
|---|---|---|
| Duloxetine | No intervention | A preliminary, open-label single center study of duloxetine in patients with SOD Receives: Drug: Duloxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Outcome Measure Was a Patient Global Assessment of Change (PGIC) Scale.
The primary outcome measure was a Patient Global Assessment of Change (PGIC) scale which reports the patient's overall view of any changes in their overall status since their sphincterotomy treatment. (1=Very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse). Success was defined as 3-month PGIC score of much or very much improved (PGIC of either 1 or 2). Patients missing the 3 month visit were considered failures for the primary outcome.
Measured: 3 months
Secondary outcomes (1)
Toleration of the Medication as Measured by the Duloxetine Compliance Rate
The secondary outcome measure of the study was number of patients who remained on Duloxetine at the completion of the study.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2007 (estimated)
- Study startJul 2006
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sphincter of Oddi DysfunctionStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Lawrence, MD, Principal investigator, MUSC Digestive Disease Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00471315
- Sponsor's protocol ID
- HR16489
- Acronym
- SOD
- Status last verified
- Feb 2009
- First submitted
- 8 May 2007
- Last updated
- 6 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Efficacy and Tolerability of Duloxetine in Patients With Suspected Functional Pancreatic/Biliary Pain (Sphincter of Oddi Dysfunction).
- ClinicalTrials.gov ID
- NCT00471315
- Acronym / sponsor ID
- SOD / HR16489
- Conditions
- Sphincter of Oddi Dysfunction
- Keywords
- SOD, Common Bile Duct Diseases, Sphincterotomy, Cholangiopancreatography, Endoscopic Retrograde
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 9 May 2007 (estimated)
- Results
- Posted 6 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open-label single center study of duloxetine in patients with SOD who have failed to respond to the standard treatments.
This protocol is designed to explore the tolerability and efficacy of Duloxetine in the management of patients with known or suspected Sphincter of Oddi dysfunction (SOD).
Detailed description
SOD is a disorder involving the bile duct or pancreas causing a burning pain or cramping in the epigastric (upper stomach) area that can radiate (spread) to the back or under the right shoulder blade. This discomfort is thought to be caused by tightening of the Sphincter of Oddi, which is the muscle opening that controls the flow of bile and juices from the pancreas (enzymes) into the small intestine. It can also be caused by contractions of the common bile duct (the duct that allows bile from the liver into the small intestine).
The purpose of this research is to study how well a medication called Duloxetine works when used to treat pain associated with SOD. Duloxetine (also called Cymbalta) is a medication approved by the FDA for the treatment of depression and for the treatment of pain caused by nerve damage associated with diabetes. However, for the purposes of this research, Duloxetine is considered investigational (experimental) since it will test how well this medication works for the treatment of pain associated with SOD. (Cymbalta replaced with Duloxetine in remainder of consent as requested).
PRIMARY OBJECTIVE
● Treatment effect as measured by the global assessment of change (PGIC) after 3 months of treatment with duloxetine.
SECONDARY OBJECTIVES
- Toleration of the medication as measured by the duloxetine compliance rate;
- Safety as recorded by adverse events (AEs)
- Effect of treatment on pain reduction as measured by a pain burden assessment tool (RAPID 3 \& RAPID 1-Month);
- Effect of treatment on quality of life (QOL) as measured by the SF-36.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Duloxetine | No intervention | Drug: DuloxetineA preliminary, open-label single center study of duloxetine in patients with SOD |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients referred to MUSC pancreatico-biliary service for investigation/ mgt of functional upper abdominal pain symptoms;
- No clinically significant medical condition(s) as determined by the investigator;
- Symptom severity. At least 2 pain attacks in the previous month, with severity of at least 4/10 on the RAPID Start scale;
- Prior cholecystectomy;
- Age 18-65*;
Key exclusion criteria (13 listed)
- History of/current psychosis, bipolar disorder, suicidal ideation or judged to be a significant suicide risk, as determined via baseline psychiatric assessment utilizing the MINI interview
- History of alcohol or any psychoactive substance abuse or dependence within the past 6 months, as determined via baseline psychiatric assessment utilizing the MINI interview
- Abnormal Liver Function Tests (> 3 x ULN)
- Known hypersensitivity to Duloxetine or any of the inactive ingredients
- Treatment with a monoamine oxidase inhibitor (MAOI) within 14 days of randomization or potential need to use an MAOI during study or within 5 days of discontinuation of study drug
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 |
|---|---|---|
| DuloxetineAlso: CymbaltaA preliminary, open-label single center study of duloxetine in patients with SOD | Drug | Duloxetine |
Primary outcome
The Primary Outcome Measure Was a Patient Global Assessment of Change (PGIC) Scale.
Time frame: 3 months
The primary outcome measure was a Patient Global Assessment of Change (PGIC) scale which reports the patient's overall view of any changes in their overall status since their sphincterotomy treatment. (1=Very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse). Success was defined as 3-month PGIC score of much or very much improved (PGIC of either 1 or 2). Patients missing the 3 month visit were considered failures for the primary outcome.
1 secondary outcome
Toleration of the Medication as Measured by the Duloxetine Compliance Rate
Time frame: 3 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- MUSC Digestive Disease Center WebsiteLink provided by the sponsor.
Related trials for Sphincter of Oddi Dysfunction
Recruiting
QST Study: Predicting Treatment Response in Chronic Pancreatitis Using Quantitative Sensory Testing
Chronic Pancreatitis, Chronic Pain
RecruitingObservational study
Seattle Spatial Transcriptomic Research in Inflammatory Bowel Disease Evaluation (STRIDE)
Inflammatory Bowel Diseases, Crohn Disease
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.
Christopher Lawrence, MD principal investigator
MUSC Digestive Disease Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Duloxetine in people with Sphincter of Oddi Dysfunction, run by Medical University of South Carolina at 1 site in United States.
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 11 inclusion and 13 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: finished, as of the sponsor's last update on 6 Feb 2014. 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 United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Primary Outcome Measure Was a Patient Global Assessment of Change (PGIC) Scale. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2014.