COPE-CP: The effect of Celecoxib on pain, quality of life, use of opioids, and inflammation in patients suffering from chronic pancreatitis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Odense University Hospital

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Decision date (initial)

2026-05-29

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Sygesikringen "danmark" (Grant 2024-0388), Monetary support · Department of Gastroenterology, Odense University Hospital (Internal Funds), Monetary support · Regionernes Medicin- og Behandlingspulje (Grant A6608), Monetary support

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Therapy

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).

Secondary objectives 4

1. To compare the effect of Celecoxib and placebo on the Izbicki Pain Score Questionnaire.
2. To evaluate the degree of inflammation measured by high-sensitivity C-reactive protein (hs-CRP) at baseline and at the end of the study.
3. To assess the use of opioids during the 16 weeks of treatment.
4. To evaluate the safety and tolerability of Celecoxib in patients with chronic pancreatitis by monitoring adverse events.

Conditions and MedDRA coding

Chronic pancreatitis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Age: Male or female individuals aged >= 18 years.
2. Diagnosis: Confirmed diagnosis of Chronic Pancreatitis (CP) according to the HaPanEU guidelines, established >= 6 months prior to screening.
3. 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.
4. Renal Function: Plasma creatinine within normal local laboratory reference range at the time of screening.
5. Contraception: For females of childbearing potential: Willingness to use a highly effective method of contraception (failure rate < 1% per year) throughout the treatment period.
6. Communication: Ability to understand, read, and speak Danish to ensure reliable completion of Patient Reported Outcomes (PROs).
7. Compliance: The investigator assesses that the participant is capable of understanding the trial requirements and is expected to comply with all study procedures.
8. Informed Consent: Ability to provide written informed consent prior to any study-related procedures.

Exclusion criteria 10

1. Recent Acute Pancreatitis: Diagnosed with acute pancreatitis requiring hospitalization within 4 weeks prior to screening.
2. Prior NSAID Use: Use of any Non-Steroidal Anti-Inflammatory Drug (NSAID) within 30 days prior to screening.
3. Prohibited Medication: Current use of ACE-inhibitors, Angiotensin-II-receptor blockers, Direct Oral Anticoagulants (DOACs), or Acetylsalicylic acid.
4. Hypersensitivity: Known allergy or hypersensitivity to Celecoxib, sulfonamides, or other NSAIDs (including history of NSAID-induced asthma or urticaria).
5. Gastrointestinal Disease: History of peptic ulcer, gastrointestinal hemorrhage, or active inflammatory bowel disease (IBD).
6. Renal or Hepatic Impairment: History of known chronic renal insufficiency, hepatic cirrhosis, or severe hepatic impairment.
7. Established Cardiovascular Disease: History of heart failure (NYHA II-IV), coronary artery disease, angina pectoris, myocardial infarction, stroke, or transient ischemic attack (TIA).
8. 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).
9. Pregnancy and Lactation: Confirmed or suspected pregnancy, planning of pregnancy during the treatment period, or breastfeeding.
10. General Safety Exclusion: Any other clinical condition or laboratory abnormality that, in the opinion of the investigators, makes the patient unsuitable for participation.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is the evaluation of the total pain burden during the 16-week treatment period. This is quantified using the validated Comprehensive Pain Assessment Tool - Short Form (COMPAT-SF). The primary analysis will be based on the Area Under the Curve (AUC) for the total pain score from baseline to week 16, comparing the Celecoxib group with the placebo group.

Secondary endpoints 7

1. Weekly Pain Profile: Change in pain intensity measured weekly throughout the 16-week treatment period using the Izbicki Pain Score.
2. Opioid Consumption: Change in total daily dose of opioids, calculated as Oral Morphine Equivalents (OME), from baseline to week 16.
3. Systemic Inflammation: Change in plasma levels of high-sensitivity C-reactive protein (hs-CRP) from baseline to week 16.
4. Overall Clinical Benefit: Proportion of patients reporting "adequate pain relief" (yes/no) at the end of the study.
5. Disease Activity: Incidence of hospital admissions related to Chronic Pancreatitis (CP) and acute pancreatitis (AP) flares, defined as amylase levels > 180 U/L in venous plasma
6. Health-Related Quality of Life: Change in Quality of Life (QoL) measured by the validated Short Form 36 (SF-36) questionnaire, completed at the same intervals as COMPAT-SF.
7. Safety and Tolerability: Incidence and severity of adverse events (AEs), with specific focus on peptic ulcer, gastrointestinal hemorrhage, impaired renal function, cardiovascular injury, hepatocellular injury, respiratory tract symptoms, and all-cause mortality.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Odense University Hospital

Sponsor organisation

Odense University Hospital

Address

J. B. Winsloews Vej 4

City

Odense C

Postcode

5000

Country

Denmark

Scientific contact point

Organisation

Odense University Hospital

Contact name

Ove B. Schaffalitzky de Muckadell

Public contact point

Organisation

Odense University Hospital

Contact name

Ove B. Schaffalitzky de Muckadell

Third parties 1

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications