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Chronic PancreatitisPhase 2PATCHNCT07755813

Pirfenidone as Treatment of Chronic Pancreatitis

A Phase 2 study testing Pirfenidone 267 mg Oral Tablet, PROMIS-Global Health and Comprehensive Pain Assessment Tool in people with Chronic Pancreatitis, run by Vikas Dudeja.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The proposed project is focused towards evaluation of Pirfenidone as a novel therapeutic strategy in patients with chronic pancreatitis (CP). Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Chronic Pancreatitis
What is being tested?
Pirfenidone 267 mg Oral Tablet, PROMIS-Global Health and Comprehensive Pain Assessment Tool
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
No sites listed yet
Study dates
Aug 2026to Aug 2030
Phase
Phase 2
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 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients 18 - 85 years of age
  • Diagnosis of CP, based on at least one of the following on CT and/or MRI/MRCP:
  • Pancreatic parenchymal and/or ductal calcification
  • Unequivocal CP on imaging (Tirkes et al3) (Cambridge grade 3 or grade 4)
  • Average pain of >/=4 (on a 0-10 scale) related to pancreatitis in the past three months [regardless of the use of pain medications (opioids or non-opioids)] and/or evidence of ongoing pancreatic inflammatory activity, with an inflammatory pancreatic flare occurring one or more times within the past six months [inflammatory pancreatic flare is defined as an exacerbation of pancreatic pain in combination with one or more of the following: 1) plasma amylase/lipase levels elevated 2-folds or more than the upper limit of normal; 2) elevated plasma levels of CRP 2-fold or more than the upper normal level without suspicion of other sources such as infection; 3) signs of pancreatic inflammation on cross-sectional imaging]
  • Ability to understand and the willingness to sign a written informed consent document and medical release
  • Willing and able to comply with trial protocol and follow up

Who cannot join

  • Age < 18 or > 85 years
  • Pancreatic endotherapy and/or pancreatic surgery and/or celiac plexus block or neurolysis in last 3 months.
  • Known hypersensitivity to Pirfenidone
  • AST and/or ALT > times the upper normal limit
  • Bilirubin higher than 1.5 times the upper normal limit
  • Moderate to severe heart failure and/or coronary heart disease (New York Heart Association (NYHA) Functional Class III/IV)
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  • On home oxygen or mechanical ventilation
  • Clinically diagnosed cirrhosis
  • Significant nausea and/or vomiting preventing administration of light diet
  • Chronic diarrhea (>6 months, 3 or more stools/day, which in investigator's opinion is not due to pancreatic exocrine insufficiency)
  • Active cancer (on chemotherapy, radiation or other treatment of cancer) or < 3 years cancer free (non-melanoma skin cancers are not exclusion)
  • Active hepatitis C
  • Known history of hepatitis B
  • Ongoing photosensitivity and rash
  • Known live vaccines or therapeutic infectious agents within one month of potential enrollment
  • Known pregnancy or lactation at the time of enrollment
  • Women of childbearing potential who are not on oral or injectable contraceptives or not using an Intrauterine device (IUD), and do not consent to adequate contraception while on, and for 90 days after the administration of the drug/placebo
  • Currently enrolled in, or has participated in, a clinical trial involving an investigational medicinal product within the past three months (if patients who have participated in a clinical trial involving an investigation medication product are included, they will only be included if they are beyond 5 half-lives from the last dose, and if there is a relevant assay available, there will be undetectable drug levels).
  • Ongoing substance use which in the opinion of the investigator may affect their participation or compliance with the study protocol
  • Alcohol consumption more than 7 drinks per week for females and more than 14 drinks per week for males.
  • Family or personal history of long QT syndrome (> 500 msec)
  • Currently using strong (e.g., fluvoxamine, enoxacin) or moderate (e.g., ciprofloxacin) CYP1A2 Inhibitors. If the patient is able to consult with their prescriber and switch to an alternative medication that is not a CYP1A2 inhibitor, they may be eligible for inclusion in the clinical trial. Any patient who stops a CYP1A2 inhibitor to be enrolled in the clinical trial, we will wait for 7 days or 5 half-lives (whichever is longer) before the study drug is started.
  • Patients taking strong CYP1A2 inducers, namely Albendazole, Carbamazepine, Primidone and Rifampin, and who cannot stop these drugs safely, will be excluded. If patients could stop these medications, they could be recruited into the study, either 14-days or 5-half lives (whichever is longer) after stopping the study drug.
  • Glomerular Filtration Rate < 60
  • Life expectancy of less than 2 years in the opinion of the investigator
  • Any medical condition that, in the opinion of the investigator, might be significantly exacerbated by the known side effects associated with the administration of pirfenidone.
  • All participants of childbearing potential, except if post-menopausal [see definition of menopause below] or had a hysterectomy, bilateral tubal ligation/clip (surgical sterilization) or surgical removal of both the ovaries), must have a negative urine pregnancy test documented within 2 days prior to initiation of the study drug.
  • Menopause can be assumed to have occurred when there is either:
  • Either twelve [12] months of spontaneous amenorrhea; or B) six [6] months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL; or C) six [6] weeks postsurgical bilateral oophorectomy with or without hysterectomy.
  • Hormonal deficiency will be documented in the case of suspected spontaneous menopause as follows:
  • If age >54 years and with the absence of normal menses: Serum FSH (Follicle Stimulating Hormone) level elevated to within the post-menopausal range based on the laboratory reference range where the hormonal assay is performed;
  • If age <54 years and with the absence of normal menses: Negative serum or urine -Human Chorionic Gonadotropin (HCG) with concurrently elevated serum FSH (Follicle Stimulating Hormone) level in the post-menopausal range, depressed estradiol (E2) level in the post-menopausal range, and absent serum progesterone level, based on the laboratory reference ranges where the hormonal assays are performed

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Vikas Dudeja, MD contact

319-353-7474

vikas-dudeja@uiowa.edu

Rimas Nemickas contact

319-353-8863

rimas-nemickas@uiowa.edu

About this study

Official title: Evaluation of Pirfenidone as a Novel Therapeutic Strategy Against Chronic Pancreatitis.

The proposed project is focused towards evaluation of Pirfenidone as a novel therapeutic strategy in patients with chronic pancreatitis (CP).

Read the detailed description

This is a multi-institutional, double-blind, placebo-controlled clinical trial of the safety, tolerability and efficacy of Pirfenidone in patients with CP. Patients with a confirmed diagnosis of CP will be randomly assigned to Pirfenidone or placebo (2:1 randomization). The assigned allocation (drug or placebo) will be continued for 48 weeks.

Subjects will be asked to complete questionnaires, have blood draws, and will be randomized to either the IP or placebo. They will have both in person and telephone/remote visits.

Being tested
Pirfenidone 267 mg Oral Tablet, Placebo, PROMIS-Global Health, Comprehensive Pain Assessment Tool, Brief Pain Inventory
Keywords
Chronic Pancreatitis, Pancreatitis
Medical subject headings
Pancreatitis, Chronic, Pancreatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pirfenidone 267 mg Oral TabletDrug

    Oral tablets taken with food three times daily. Titrated over 14 days: one tablet three times daily in week 1, two tablets three times daily in week 2, and three tablets three times daily (801 mg three times daily) from week 3 onward. Continued for 48 weeks unless reduced or interrupted to manage an adverse event. Dispensed by Investigational Drug Services according to the randomization code.

  • PlaceboDrug

    Matching placebo tablets, identical in appearance and packaging to the pirfenidone tablets to maintain double blinding. Administered on the same schedule: one tablet three times daily in week 1, two in week 2, and three from week 3 onward, taken with food, for a total of 48 weeks. Dispensed by Investigational Drug Services according to the randomization code.

  • PROMIS-Global HealthOther

    Also called PROMIS-GH

    Patient-reported outcome instrument administered to all participants in both arms to assess health-related quality of life. Completed by the participant at Weeks 0, 4, 12, 24, 36, 48, 60, 72, 84 and 96, and at Early Termination.

  • Comprehensive Pain Assessment ToolOther

    Also called COMPAT-SF

    Patient-reported outcome instrument administered to all participants in both arms to assess perceived pain. Completed by the participant at Weeks 0, 4, 12, 24, 36, 48, 60, 72, 84 and 96, and at Early Termination.

  • Brief Pain InventoryOther

    Also called BPI

    Patient-reported outcome instrument administered to all participants in both arms. Administered once per visit and used for two purposes: the pain severity items assess perceived pain, and the pain interference items assess ability to participate in social roles and activities. Completed by the participant at Weeks 0, 4, 12, 24, 36, 48, 60, 72, 84 and 96, and at Early Termination.

  • Pancreatitis Quality of Life InstrumentOther

    Also called PANQOLI

    Patient-reported outcome instrument administered to all participants in both arms to assess ability to participate in social roles and activities. Completed by the participant at Weeks 0, 4, 12, 24, 36, 48, 60, 72, 84 and 96, and at Early Termination.

Study groups in NCT07755813
Study groupRoleWhat they receive
PirfenidoneExperimentalParticipants receive pirfenidone 267 mg oral tablets, taken with food three times daily. The dose is titrated over 14 days: one tablet three times daily during week 1, two tablets three times daily during week 2, and three tablets three times daily (801 mg three times daily) from week 3 onward. Treatment continues for a total of 48 weeks. All participants in this arm also complete the PROMIS-Global Health, COMPAT-SF, Brief Pain Inventory, and PANQOLI role function subscale instruments at Weeks 0, 4, 12, 24, 36, 48, 60, 72, 84 and 96.
Receives: Drug: Pirfenidone 267 mg Oral Tablet; Other: PROMIS-Global Health; Other: Comprehensive Pain Assessment Tool; Other: Brief Pain Inventory; Other: Pancreatitis Quality of Life Instrument
PlaceboPlacebo comparatorParticipants receive matching placebo oral tablets, taken with food three times daily. The number of tablets follows the same schedule as the pirfenidone arm over 14 days: one tablet three times daily during week 1, two tablets three times daily during week 2, and three tablets three times daily from week 3 onward. Treatment continues for a total of 48 weeks. All participants in this arm also complete the PROMIS-Global Health, COMPAT-SF, Brief Pain Inventory, and PANQOLI role function subscale instruments at Weeks 0, 4, 12, 24, 36, 48, 60, 72, 84 and 96.
Receives: Drug: Placebo; Other: PROMIS-Global Health; Other: Comprehensive Pain Assessment Tool; Other: Brief Pain Inventory; Other: Pancreatitis Quality of Life Instrument

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With at Least One Grade 3 or Grade 4 Adverse Event as Assessed by CTCAE Version 5.0

    Adverse events will be assessed and graded using a modified Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, which grades events from Grade 1, mild, to Grade 5, death related to adverse event. A participant is counted once if one or more adverse events of Grade 3 or Grade 4 are recorded during the treatment period, regardless of how many such events occur. The proportion of participants meeting this criterion will be compared between the pirfenidone and placebo arms.

    Measured: From first dose of study drug through Week 48

Secondary outcomes (11)

  1. Rate of Pancreatitis-Related Emergency Room Visits Not Requiring Hospital Admission Per Participant-Year

    : The total number of emergency room visits attributed to pancreatitis, comprising visits for pancreatic pain, for episodes of acute pancreatitis, or for pancreatitis-related complications, that did not result in hospital admission, divided by the total participant-years of follow-up. Reported as events per participant-year; higher values indicate more frequent visits.

    Measured: From randomization through Week 96

  2. Rate of Pancreatitis-Related Hospital Admissions Per Participant-Year

    The total number of hospital admissions attributed to pancreatitis, comprising admissions for pancreatic pain, for episodes of acute pancreatitis, or for pancreatitis-related complications, divided by the total participant-years of follow-up. Reported as events per participant-year; higher values indicate more frequent admissions.

    Measured: From randomization through Week 96

  3. Number of Participants With at Least One Documented Episode of Acute Pancreatitis

    An episode of acute pancreatitis is documented by amylase or lipase elevation of two times or more the upper limit of normal, by findings of pancreatic inflammation on cross-sectional imaging, or by clinical diagnosis alone. Episodes are counted whether or not they result in an emergency room visit or hospital admission. A participant is counted once if one or more such episodes occur.

    Measured: From randomization through Week 96

  4. Mean Change From Baseline in PROMIS Global Health Global Physical Health T-Score

    The Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health short form is self-completed by the participant. Global Physical Health raw scores are converted to a T-score calibrated so that the United States general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better physical health.

    Measured: Baseline (Week 0), Week 48, and Week 96

  5. Mean Change From Baseline in PROMIS Global Health Global Mental Health T-Score

    The Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health short form is self-completed by the participant. Global Mental Health raw scores are converted to a T-score calibrated so that the United States general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better mental health.

    Measured: Baseline (Week 0), Week 48, and Week 96

  6. Mean Change From Baseline in Comprehensive Pain Assessment Tool Short Form (COMPAT-SF) Total Score

    The Comprehensive Pain Assessment Tool Short Form is a pancreatitis-specific multidimensional pain instrument self-completed by the participant. Higher scores indicate greater pain burden.

    Measured: Baseline (Week 0), Week 48, and Week 96

  7. Mean Change From Baseline in Brief Pain Inventory Pain Severity Score

    The Brief Pain Inventory is self-completed by the participant. The four pain severity items are each scored from 0, no pain, to 10, pain as bad as you can imagine, and are averaged to produce a severity score ranging from 0 to 10. Higher scores indicate greater pain severity.

    Measured: Baseline (Week 0), Week 48, and Week 96

  8. Mean Change From Baseline in PANQOLI Role Function Subscale Score

    The role function subscale of the Pancreatitis Quality of Life Instrument (PANQOLI) is self-completed by the participant.

    Measured: Baseline (Week 0), Week 48, and Week 96

  9. Mean Change From Baseline in Opioid Use Measured in Morphine Milligram Equivalents

    Opioid dispensing records are obtained from the Prescription Drug Monitoring Program with participant consent and are complemented by participant-reported intake. Total opioid consumption over the 30 days preceding each assessment is converted to morphine milligram equivalents using established conversion factors. Higher values indicate greater opioid use.

    Measured: The 30 days preceding Baseline (Week 0), Week 48, and Week 96

  10. Number of Participants With a New Diagnosis of Pancreatic Endocrine Dysfunction

    Endocrine status is determined by hemoglobin A1c and by fasting or random blood glucose, interpreted by the investigator. A new diagnosis is recorded where the investigator determines that endocrine dysfunction is present at an assessment timepoint in a participant who did not have a diagnosis of diabetes at Week 0. A participant is counted once.

    Measured: Baseline (Week 0), Week 48, and Week 96

  11. Number of Participants With a New Diagnosis of Pancreatic Exocrine Dysfunction

    Exocrine status is determined by fecal elastase measured on a participant-collected stool specimen. A new diagnosis is recorded where the investigator determines that exocrine insufficiency is present at an assessment timepoint in a participant who did not have exocrine insufficiency at the first timepoint. A participant is counted once.

    Measured: Within 2 months after first dose of study drug, at Week 48, and at Week 96

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2026
  2. Study startAug 2026 (estimated)
  3. Primary completionAug 2030 (estimated)
  4. Study completionAug 2030 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07755813
Sponsor's protocol ID
202506378
Acronym
PATCH
Status last verified
Aug 2026
First submitted
4 Aug 2026
Last updated
10 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Results will be published in clinicaltrials.gov

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pirfenidone 267 mg Oral Tablet, PROMIS-Global Health and Comprehensive Pain Assessment Tool in people with Chronic Pancreatitis, run by Vikas Dudeja.

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 7 inclusion and 32 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: opening soon, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Vikas Dudeja, MD (319-353-7474, vikas-dudeja@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With at Least One Grade 3 or Grade 4 Adverse Event as Assessed by CTCAE Version 5.0 (time frame: From first dose of study drug through Week 48). 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 NCT07755813.

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 10 Aug 2026.

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