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Celecoxib versus placebo for pain and quality of life in adult patients with chronic pancreatitis

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on adults with Chronic Pancreatitis, a long‑lasting inflammation of the pancreas that often causes repeated episodes of abdominal pain and can lead to digestive problems. Participants will receive either the oral pain‑relieving drug Celecoxib, which belongs to a class of medicines known as NSAIDs, or a matching placebo. The goal is to find out whether the active medication can reduce pain, improve quality of life, lower the need for strong painkillers called opioids, and decrease signs of inflammation.

Each person will take the assigned tablet twice daily for about four months. During this time, they will complete a simple questionnaire called the Comprehensive Pain Assessment Tool Short Form (COMPAT‑SF) to record how much pain they feel, and another survey called the Short Form 36 (SF‑36) to evaluate overall well‑being. Blood samples will be taken to measure a protein linked to inflammation, known as high‑sensitivity C‑reactive protein (hs‑CRP), and the amount of opioid medication used will be expressed as oral morphine equivalents (OME). These checks are done at regular clinic visits, but no detailed technical procedures are required from the participants.

Safety is closely watched throughout the trial; doctors will look for any stomach irritation, bleeding, kidney changes, heart problems, or liver issues that might arise. Any unwanted effects are recorded and evaluated to ensure the treatment is well tolerated. The information gathered will help determine if the medication offers a meaningful benefit for people living with this condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and baseline assessment

    After joining the trial, baseline information is collected. this includes a medical history of chronic pancreatitis, a pain questionnaire (COMPAT‑SF), a quality of life questionnaire (SF‑36), blood tests for inflammation (hs‑CRP), and a record of current opioid use.

  2. Step 2

    Randomization and start of study medication

    The participant is randomly assigned to receive either celecoxib 400 mg taken orally once daily or a matching placebo capsule taken orally once daily.

    In addition, all participants take pantoprazole 80 mg gastro‑resistant tablet orally once daily to protect the stomach.

    Both the study medication and pantoprazole are taken for a continuous period of 16 weeks.

  3. Step 3

    Weekly symptom and safety monitoring

    Each week the participant records pain intensity using the Izbicki Pain Score and notes any opioid use.

    Any side effects or adverse events are reported through a weekly questionnaire.

  4. Step 4

    Scheduled clinic visits

    Clinic visits occur at week 4, week 8, week 12, and week 16.

    During each visit blood is drawn to measure hs‑CRP and other safety parameters, and the participant completes the SF‑36 quality of life questionnaire.

    The study team reviews medication adherence, pain reports, opioid consumption, and any adverse events.

  5. Step 5

    End of treatment assessment

    At week 16 the participant stops taking the study medication and pantoprazole.

    Final assessments are performed, including the total pain burden (COMPAT‑SF), quality of life (SF‑36), opioid dose, and blood tests for inflammation.

    The participant reports whether pain relief is considered adequate.

  6. Step 6

    Study completion

    After the final visit, data are compiled for analysis. no further medication is required.

Who can join the trial?

8 criteria

  • Be 18 years old or older.
  • Have a confirmed diagnosis of chronic pancreatitis (long‑term inflammation of the pancreas) that was made at least 6 months before screening.
  • Experience ongoing pain from chronic pancreatitis with an average pain rating of 4 to 9 on a 0‑to‑10 Numeric Rating Scale (0 = no pain, 10 = worst possible pain) during the past 6 months.
  • Show normal kidney function, measured by a blood test called plasma creatinine that is within the normal range.
  • If you are a woman who could become pregnant, be willing to use a highly effective method of contraception (less than 1% chance of pregnancy per year) throughout the treatment period.
  • Be able to understand, read, and speak Danish so you can complete study questionnaires.
  • Be judged by the doctor to understand the study requirements and be able to follow all study procedures.
  • Be able to sign a written informed consent form before any study activities begin.

Who cannot join the trial?

10 criteria

  • Recent acute pancreatitis: if you have had a sudden inflammation of the pancreas that required a hospital stay within the past 4 weeks, you cannot join.
  • General safety: any other health problem or abnormal lab test that the doctors feel makes participation unsafe will exclude you.
  • Recent use of NSAIDs: taking any non‑steroidal anti‑inflammatory drug (pain relievers such as ibuprofen, naproxen, etc.) within 30 days before screening prevents enrollment.
  • Prohibited medications: currently using ACE‑inhibitors (blood‑pressure medicines), Angiotensin‑II‑receptor blockers (another type of blood‑pressure medicine), Direct Oral Anticoagulants (blood thinners), or Acetylsalicylic acid (aspirin) will exclude you.
  • Allergy or hypersensitivity: known allergy to Celecoxib, sulfonamides (a class of antibiotics), or other NSAIDs, or a past reaction such as asthma or hives caused by NSAIDs, means you cannot participate.
  • Gastrointestinal disease: a history of peptic ulcer (stomach sore), gastrointestinal bleeding, or active inflammatory bowel disease (conditions like Crohn’s disease or ulcerative colitis) excludes you.
  • Kidney or liver problems: having chronic kidney disease, liver cirrhosis (scarring of the liver), or severe liver impairment prevents participation.
  • Established heart or blood‑vessel disease: a past diagnosis of heart failure (moderate to severe), coronary artery disease, chest pain (angina), heart attack, stroke, or mini‑stroke (transient ischemic attack) will exclude you.
  • High cardiovascular risk (SCORE2): if a heart‑risk calculator shows a moderate‑to‑high risk of cardiovascular disease—greater than 5% for ages 40‑59, greater than 7.5% for ages 60‑69, or greater than 10% for ages 70‑75—you cannot join.
  • Pregnancy or breastfeeding: being pregnant, planning to become pregnant during the study, suspecting pregnancy, or breastfeeding will exclude you.
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Investigated drugs

  • Celecoxib

    is an oral non‑steroidal anti‑inflammatory drug (NSAID) that is being tested to see if it can lower pain, improve quality of life, reduce the need for opioid medicines, and decrease inflammation in people with chronic pancreatitis. Participants will take this medication for 16 weeks while the study compares its effects to a placebo.

  • Pantoprazole

    is a medicine that reduces stomach acid. In this trial it is given to all participants as background therapy to help protect the stomach lining, especially because NSAIDs like celecoxib can sometimes cause stomach irritation. It is taken as a gastro‑resistant tablet.

What is already known about the treatment

  • CELECOXIB

    This medication is taken by mouth as a hard capsule, usually 400 mg once daily. It is an approved drug that is widely used and studied as a pain‑relieving anti‑inflammatory agent. Celecoxib works by selectively blocking the COX‑2 enzyme, which lowers the production of chemicals that cause pain and swelling. It belongs to the class of selective COX‑2 non‑steroidal anti‑inflammatory drugs (NSAIDs).

  • Pantoprazole

    Pantoprazole is swallowed as a gastro‑resistant tablet, typically 40 mg taken once a day. It is an established, prescription medicine used to treat conditions caused by excess stomach acid, such as heartburn and ulcers. The drug reduces acid by inhibiting the stomach’s proton pump, a protein that normally releases acid into the stomach. It is classified as a proton‑pump inhibitor (PPI).

Investigated diseases

Chronic pancreatitis – Chronic pancreatitis is a long‑lasting inflammation of the pancreas that slowly damages the organ. Over time the inflammation creates scar tissue, reducing the pancreas’s ability to produce digestive enzymes and hormones. Episodes of pain and swelling may occur repeatedly, each one adding to the damage. As the disease advances, the pancreas becomes less able to help digest food, leading to digestive problems. The condition often follows a pattern of flare‑ups followed by periods of fewer symptoms.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522956-25-00Protocol code1Estimated enrolment80 patientsSponsorOdense University Hospital

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).