2025-522956-25-00招募中3 期
COPE-CP: The effect of Celecoxib on pain, quality of life, use of opioids, and inflammation in patients suffering from chronic pancreatitis: a multicenter randomized placebo-controlled, double-blinded clinical trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- 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.
研究概览
简要总结
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).
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Pantoprazole 40 mg gastro-resistant tablets
Auxiliary
干预措施: Pantoprazole 40 mg gastro-resistant tablets (Drug)
CELECOXIB
Test
干预措施: CELECOXIB (Drug)
Placebo matching celecoxib 200 mg hard capsules
Placebo
干预措施: Placebo matching celecoxib 200 mg hard capsules (Drug)
结局指标
主要结局
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.
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.
次要结局
- Weekly Pain Profile: Change in pain intensity measured weekly throughout the 16-week treatment period using the Izbicki Pain Score.
- Opioid Consumption: Change in total daily dose of opioids, calculated as Oral Morphine Equivalents (OME), from baseline to week 16.
- Systemic Inflammation: Change in plasma levels of high-sensitivity C-reactive protein (hs-CRP) from baseline to week 16.
- Overall Clinical Benefit: Proportion of patients reporting "adequate pain relief" (yes/no) at the end of the study.
- 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
- 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.
- 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.
研究者
Ove B. Schaffalitzky de Muckadell
Scientific
Odense University Hospital
研究点 (3)
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