Pirfenidone as Treatment of Chronic Pancreatitis

Summary

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

Conditions

• Chronic Pancreatitis

Interventions

DRUG

Pirfenidone 267 mg Oral Tablet

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.

DRUG

Placebo

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.

OTHER

PROMIS-Global Health

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.

OTHER

Comprehensive Pain Assessment Tool

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.

OTHER

Brief Pain Inventory

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.

OTHER

Pancreatitis Quality of Life Instrument

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.

Sponsors & Collaborators

• United States Department of Defense

  collaborator FED

• Vikas Dudeja

  lead OTHER

Principal Investigators

• Vikas Dudeja, MD · University of Iowa

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-31

Primary Completion

2030-08-31

Completion

2030-08-31

FDA Drug

Yes