Recurrent Acute PancreatitisEarly Phase 1SMV in CPNCT05771675
Simvastatin Treatment to Improve Patient-reported Outcomes in Patients With Chronic Pancreatitis
A Early Phase 1 study testing Simvastatin in people with Recurrent Acute Pancreatitis and Chronic Pancreatitis, run by Cedars-Sinai Medical Center at 5 sites in United States.
Trial summary
The purpose of this pilot study to examine the feasibility and acceptability of simvastatin in adults with Recurrent Acute Pancreatitis (RAP) and Chronic Pancreatitis (CP). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Recurrent Acute Pancreatitis, Chronic Pancreatitis
- What is being tested?
- Simvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 5 sitesUnited States
- Study dates
- 24 Oct 2024to Jun 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18-75 at time of enrollment
- Diagnosis of Recurrent Acute or Chronic Pancreatitis not attributable to gallstones (i.e., suspected or definite biliary etiology), medications, trauma or autoimmune pancreatitis. For CP, imaging studies that can be used for diagnosis classification using Cambridge criteria46,47.
- Ability to take oral medication and be willing to adhere to the dosing regimen.
- For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional one month after administration of study medication.
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- For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional one month after administration of study medication.
- No prior pancreatic surgery
- No current statin use for 6 months.
Who cannot join
- Pregnancy or lactation
- History of autoimmune, medication caused or traumatic pancreatitis.
- Primary pancreatic tumors - pancreatic ductal adenocarcinoma, suspected cystic neoplasm (>1 cm. in size or main duct involvement), neuroendocrine tumors, and other uncommon tumors.
- Pancreatic metastasis from other malignancies.
- History of solid organ transplant, HIV/AIDS.
- Known isolated pancreatic exocrine insufficiency (i.e.., in the absence of any eligible inclusion criteria).
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- Subjects required to take itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone, gemfibrozil, cyclosporine, danazol, amiodarone, or verapamil for other clinical indications.
- Current simvastatin use within the past 6 months.
- Participants must not have medical or psychiatric illnesses or ongoing substance abuse that in the investigator's opinion would compromise their ability to tolerate study interventions or participate in longitudinal follow up.
- Patients with active liver disease.
- Known Pregnancy. All participants of childbearing potential, except if post-menopausal (i.e., no menses for ≥2 years) or had a hysterectomy, bilateral tubal ligation/clip (surgical sterilization) or surgical removal of both the ovaries), must have a negative urine or serum B-HCG pregnancy test documented within 2 days prior to any endoscopic or radiologic procedures done for research purposes. Any standard of care tests will follow institutional policies regarding pregnancy test.
- Currently incarcerated.
- Inability to comply with study activities.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Arax Shanlian contact
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Ohio State University
Columbus, Ohio, 43210
Spencer Harris, 614-366-7453, Spencer.Harris@osumc.edu
Usman Sajid, 614-366-7453, Usman.Sajid@osumc.edu
- Recruiting
University of Southern California
Los Angeles, California, 90033
Jorge Zuniga-Gomez, 323-442-0876, Jorge.ZunigaGomez@med.usc.edu
James Buxbaum, MD
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Arax Shanlian, 310-967-1110, arax.shanlian@cshs.org
Erika Padilla, 310-967-1109, erika.padilla@cshs.org
- Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Kelly Wood, 412-647-1458, etheringtonka@upmc.edu
Tina Tomko, 412-647-1120, tomkot@upmc.edu
- Recruiting
Stanford University
Stanford, California, 94305
Lorena Pineda, 650-725-2767, ljpineda@stanford.edu
Walter Park, MD
About this study
The purpose of this pilot study to examine the feasibility and acceptability of simvastatin in adults with Recurrent Acute Pancreatitis (RAP) and Chronic Pancreatitis (CP).
Read the detailed description
There are no available treatments for chronic pancreatitis (CP) or recurrent acute pancreatitis (RAP) and patients suffer with unremitting abdominal pain as the disease progress. This pilot study will test the feasibility of conducting a clinical trial of simvastatin to enhance the quality of life and delay disease progression in chronic pancreatitis patients. Emerging understanding of pancreas acinar cell organellar disorders underlying pancreatitis and the potential benefits of simvastatin to restore acinar cell homeostasis along with understanding of the pathways of the fibro-inflammatory response emanating from the disorders in the acinar cell allow the study team to propose a pilot placebo controlled double blind trial in patients with CP and RAP to test the effect of simvastatin on patient reported outcomes. Of note, RAP is a form of pancreatitis preceding CP.
The Study Team hypothesizes that treatment with simvastatin will have a significant benefit for reducing pain, improving health-related quality of life (HRQoL) and pancreatitis-related outcomes in patients with CP and RAP. Changes in blood biomarkers during treatments will provide biochemical evidence for the effectiveness of the treatments. The proposed study is a pilot double blind trial with 2:1 assignment of simvastatin vs placebo. 90 patients with either CP or RAP will be enrolled over a 24-month recruitment period. Treatment with simvastatin or placebo will be for 6 months. Outcome measures will be obtained at baseline, 3 months, and 6 months and 6 months after discontinuation of treatment for a total of one year. Feasibility and adherence will be monitored.
The Primary aim of this pilot study is to examine feasibility and acceptability of the trial in adults with RAP and CP. A priori thresholds to evaluate feasibility are: 50% enrollment, <15% attrition, >75% adherence with doses, <20% side effects, and >75% acceptability ratings. Multiple secondary outcome measures will be obtained that determine the effect of the treatments on pain and Quality of Life (QoL). The study plans to include male and female participants >18 years of age with Chronic and Recurrent Acute pancreatitis. Each participant will be involved for a period of 12 months from enrollment to completion of the study unless withdrawn by the study team for reasons of safety or by the participant for personal reasons.
- Conditions
- Recurrent Acute Pancreatitis, Chronic Pancreatitis
- Being tested
- Simvastatin, Placebo
- Medical subject headings
- Pancreatitis, Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimvastatinDrug
40Mg Oral Tablet
PlaceboDrug
Matching Simvastatin Placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Simvastatin | Experimental | Participants receive Simvastatin 40mg capsule once daily for 6 months. Receives: Drug: Simvastatin |
| Placebo | Placebo comparator | Participants receive Placebo capsule matching Simvastatin once daily for 6 months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examine the feasibility and acceptability of testing the effect of simvastatin on health-related quality of life outcomes in patients with recurrent acute and chronic pancreatitis.
A priori thresholds to evaluate feasibility are: 50% enrollment, <15% attrition, >75% adherence with doses, <20% side effects. A score of >75% acceptability ratings per an "Acceptability Form" that will be provided during the last visit will be used to gauge the general acceptability of the intervention (Simvastatin or Placebo) and study procedures to each participating subject.
Measured: End of study (12 Months)
Secondary outcomes (1)
Determine the effect of simvastatin treatment on health-related quality of life (QoL) outcomes in patients with recurrent acute and chronic pancreatitis.
Health-related quality of life measurements will be collected via questionnaires (PROMIS Sleep Disturbance and Physical Short Form, Physical Distress scale, pain scales, and the Pancreatic Quality of Life Instrument) to assess overall health, quality of life, and compare the mean change from baseline across the times points 3, 6, and 12 months between the treatment group and placebo in order to identify improvement in overall quality of life and pain management.
The study will also collect blood samples to look for exploratory biomarkers to identify potential measures of response to treatment with the intent do develop larger efficacy focused trials.
Measured: End of study (12 Months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start24 Oct 2024
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Acute PancreatitisStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Drug: Simvastatin Drug: Placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Stephen Pandol, MD, Cedars-Sinai Medical Center
- Investigators
- Stephen Pandol, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05771675
- Sponsor's protocol ID
- STUDY00002293
- Other IDs
- CDMRP-PR221971
- Acronym
- SMV in CP
- Status last verified
- Aug 2026
- First submitted
- 2 Feb 2023
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simvastatin Treatment to Improve Patient-reported Outcomes in Patients With Chronic Pancreatitis
- ClinicalTrials.gov ID
- NCT05771675
- Acronym / sponsor ID
- SMV in CP / STUDY00002293
- Conditions
- Recurrent Acute Pancreatitis, Chronic Pancreatitis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 16 Mar 2023 (actual)
- 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.
The purpose of this pilot study to examine the feasibility and acceptability of simvastatin in adults with Recurrent Acute Pancreatitis (RAP) and Chronic Pancreatitis (CP).
Detailed description
There are no available treatments for chronic pancreatitis (CP) or recurrent acute pancreatitis (RAP) and patients suffer with unremitting abdominal pain as the disease progress. This pilot study will test the feasibility of conducting a clinical trial of simvastatin to enhance the quality of life and delay disease progression in chronic pancreatitis patients. Emerging understanding of pancreas acinar cell organellar disorders underlying pancreatitis and the potential benefits of simvastatin to restore acinar cell homeostasis along with understanding of the pathways of the fibro-inflammatory response emanating from the disorders in the acinar cell allow the study team to propose a pilot placebo controlled double blind trial in patients with CP and RAP to test the effect of simvastatin on patient reported outcomes. Of note, RAP is a form of pancreatitis preceding CP.
The Study Team hypothesizes that treatment with simvastatin will have a significant benefit for reducing pain, improving health-related quality of life (HRQoL) and pancreatitis-related outcomes in patients with CP and RAP. Changes in blood biomarkers during treatments will provide biochemical evidence for the effectiveness of the treatments. The proposed study is a pilot double blind trial with 2:1 assignment of simvastatin vs placebo. 90 patients with either CP or RAP will be enrolled over a 24-month recruitment period. Treatment with simvastatin or placebo will be for 6 months. Outcome measures will be obtained at baseline, 3 months, and 6 months and 6 months after discontinuation of treatment for a total of one year. Feasibility and adherence will be monitored.
The Primary aim of this pilot study is to examine feasibility and acceptability of the trial in adults with RAP and CP. A priori thresholds to evaluate feasibility are: 50% enrollment, <15% attrition, >75% adherence with doses, <20% side effects, and >75% acceptability ratings. Multiple secondary outcome measures will be obtained that determine the effect of the treatments on pain and Quality of Life (QoL). The study plans to include male and female participants >18 years of age with Chronic and Recurrent Acute pancreatitis. Each participant will be involved for a period of 12 months from enrollment to completion of the study unless withdrawn by the study team for reasons of safety or by the participant for personal reasons.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Drug: Simvastatin Drug: Placebo
| Arm | Type | Receives |
|---|---|---|
| Simvastatin | Experimental | Drug: SimvastatinParticipants receive Simvastatin 40mg capsule once daily for 6 months. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants receive Placebo capsule matching Simvastatin once daily for 6 months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18-75 at time of enrollment
- Diagnosis of Recurrent Acute or Chronic Pancreatitis not attributable to gallstones (i.e., suspected or definite biliary etiology), medications, trauma or autoimmune pancreatitis. For CP, imaging studies that can be used for diagnosis classification using Cambridge criteria46,47.
- Ability to take oral medication and be willing to adhere to the dosing regimen.
Key exclusion criteria (13 listed)
- Pregnancy or lactation
- History of autoimmune, medication caused or traumatic pancreatitis.
- Primary pancreatic tumors - pancreatic ductal adenocarcinoma, suspected cystic neoplasm (>1 cm. in size or main duct involvement), neuroendocrine tumors, and other uncommon tumors.
- Pancreatic metastasis from other malignancies.
- History of solid organ transplant, HIV/AIDS.
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 |
|---|---|---|
| Simvastatin40Mg Oral Tablet | Drug | Simvastatin |
| PlaceboMatching Simvastatin Placebo tablet | Drug | Placebo |
Primary outcome
Examine the feasibility and acceptability of testing the effect of simvastatin on health-related quality of life outcomes in patients with recurrent acute and chronic pancreatitis.
Time frame: End of study (12 Months)
A priori thresholds to evaluate feasibility are: 50% enrollment, <15% attrition, >75% adherence with doses, <20% side effects. A score of >75% acceptability ratings per an "Acceptability Form" that will be provided during the last visit will be used to gauge the general acceptability of the intervention (Simvastatin or Placebo) and study procedures to each participating subject.
1 secondary outcome
Determine the effect of simvastatin treatment on health-related quality of life (QoL) outcomes in patients with recurrent acute and chronic pancreatitis.
Time frame: End of study (12 Months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- 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.
Arax Shanlian contact
Stephen Pandol, MD principal investigator
Cedars-Sinai Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Simvastatin in people with Recurrent Acute Pancreatitis and Chronic Pancreatitis, run by Cedars-Sinai Medical Center at 5 sites 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 9 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: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arax Shanlian (3109671110, arax.shanlian@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Examine the feasibility and acceptability of testing the effect of simvastatin on health-related quality of life outcomes in patients with recurrent acute and chronic pancreatitis. (time frame: End of study (12 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 5 Aug 2026.