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COPE-CP: The effect of Celecoxib on pain, quality of life, use of opioids, and inflammation in patients suffering from chronic pancreatitis
EU CTIS ID: 2025-522956-25-00
What this study is testing
The aim of this investigator-initiated, randomized, controlled trial in adult Danish patients suffering from chronic pancreatitis (CP) is to evaluate the effect of Celecoxib, an oral NSAID, compared with placebo during 16 weeks of treatment. The primary objective is to assess patient-reported pain and quality of life (QoL) measured by the Comprehensive Pain Assessment Tool Short Form for Chronic Pancreatitis (COMPAT-SF).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age: Male or female individuals aged >= 18 years.
- Diagnosis: Confirmed diagnosis of Chronic Pancreatitis (CP) according to the HaPanEU guidelines, established >= 6 months prior to screening.
- Pain Status: Symptomatic CP with a mean pain intensity >= 4 and <= 9 on a Numeric Rating Scale (NRS, 0-10) during the last 6 months.
- Renal Function: Plasma creatinine within normal local laboratory reference range at the time of screening.
- Contraception: For females of childbearing potential: Willingness to use a highly effective method of contraception (failure rate < 1% per year) throughout the treatment period.
- Communication: Ability to understand, read, and speak Danish to ensure reliable completion of Patient Reported Outcomes (PROs).
You likely can't join if
- Recent Acute Pancreatitis: Diagnosed with acute pancreatitis requiring hospitalization within 4 weeks prior to screening.
- General Safety Exclusion: Any other clinical condition or laboratory abnormality that, in the opinion of the investigators, makes the patient unsuitable for participation.
- Prior NSAID Use: Use of any Non-Steroidal Anti-Inflammatory Drug (NSAID) within 30 days prior to screening.
- Prohibited Medication: Current use of ACE-inhibitors, Angiotensin-II-receptor blockers, Direct Oral Anticoagulants (DOACs), or Acetylsalicylic acid.
- Hypersensitivity: Known allergy or hypersensitivity to Celecoxib, sulfonamides, or other NSAIDs (including history of NSAID-induced asthma or urticaria).
- Gastrointestinal Disease: History of peptic ulcer, gastrointestinal hemorrhage, or active inflammatory bowel disease (IBD).
See the full eligibility criteria
- Age: Male or female individuals aged >= 18 years.
- Diagnosis: Confirmed diagnosis of Chronic Pancreatitis (CP) according to the HaPanEU guidelines, established >= 6 months prior to screening.
- Pain Status: Symptomatic CP with a mean pain intensity >= 4 and <= 9 on a Numeric Rating Scale (NRS, 0-10) during the last 6 months.
- Renal Function: Plasma creatinine within normal local laboratory reference range at the time of screening.
- Contraception: For females of childbearing potential: Willingness to use a highly effective method of contraception (failure rate < 1% per year) throughout the treatment period.
- Communication: Ability to understand, read, and speak Danish to ensure reliable completion of Patient Reported Outcomes (PROs).
- Compliance: The investigator assesses that the participant is capable of understanding the trial requirements and is expected to comply with all study procedures.
- Informed Consent: Ability to provide written informed consent prior to any study-related procedures.
- Recent Acute Pancreatitis: Diagnosed with acute pancreatitis requiring hospitalization within 4 weeks prior to screening.
- General Safety Exclusion: Any other clinical condition or laboratory abnormality that, in the opinion of the investigators, makes the patient unsuitable for participation.
- Prior NSAID Use: Use of any Non-Steroidal Anti-Inflammatory Drug (NSAID) within 30 days prior to screening.
- Prohibited Medication: Current use of ACE-inhibitors, Angiotensin-II-receptor blockers, Direct Oral Anticoagulants (DOACs), or Acetylsalicylic acid.
- Hypersensitivity: Known allergy or hypersensitivity to Celecoxib, sulfonamides, or other NSAIDs (including history of NSAID-induced asthma or urticaria).
- Gastrointestinal Disease: History of peptic ulcer, gastrointestinal hemorrhage, or active inflammatory bowel disease (IBD).
- Renal or Hepatic Impairment: History of known chronic renal insufficiency, hepatic cirrhosis, or severe hepatic impairment.
- Established Cardiovascular Disease: History of heart failure (NYHA II-IV), coronary artery disease, angina pectoris, myocardial infarction, stroke, or transient ischemic attack (TIA).
- Cardiovascular Risk (SCORE2): Moderate-to-high risk of cardiovascular disease assessed by SCORE2/SCORE2-OP tools exceeding: >5.0% (age 40-59), >7.5% (age 60-69), or >10% (age 70-75).
- Pregnancy and Lactation: Confirmed or suspected pregnancy, planning of pregnancy during the treatment period, or breastfeeding.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.