Pirfenidone as Treatment of Chronic Pancreatitis

Sponsor
Vikas Dudeja
Study ID
NCT07755813
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Pirfenidone 267 mg Oral Tablet — DRUG
    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.
  • Placebo — DRUG
    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 Health — OTHER
    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 Tool — OTHER
    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 Inventory — OTHER
    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 Instrument — OTHER
    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 Details

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

Key Dates

First listed
Aug 10, 2026
Start date
Aug 31, 2026
Status verified
Aug 2026
Primary completion
Aug 31, 2030
Completion
Aug 31, 2030

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pirfenidone
    Participants 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.
  • Placebo Comparator: Placebo
    Participants 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.

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 ]

Central Contacts

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