Phase 1/2 Trial of Indomethacin in Chronic Pancreatitis (The PAIR Trial)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Change in Prostaglandin E2 (PGE2) Concentrations
研究概览
简要总结
The researchers are trying to find a way to slow down the progression of chronic pancreatitis (CP) and investigate the possibility of the long term treatment of this disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Blinding: Study medication will be labelled "indomethacin 50 mg or placebo capsule" with the subject's name, hospital or clinic number, study IRB number, and subject number. Placebo and indomethacin capsules will be identical in appearance. The investigators, study coordinator, and clinical caregivers will remain blinded to subject allocation throughout the data ascertainment and data entry phase of the study.
The success of blinding will be evaluated by asking the investigator, the study coordinator, and the subject the following question during each telephone follow-up visit: "Which treatment group is this subject/were you assigned to: placebo, active drug, or unsure?"
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any gender, age ≥ 18 years and < 60 years
- •Diagnosed with chronic pancreatitis per American Pancreatic Association guidelines (pancreatic calcifications and/or Cambridge 3-4 changes on CT, MRI, and/or ERCP)
- •Scheduled for an upper GI endoscopic procedure (EGD or EUS) for clinical or research) indications (not conflicting with current investigation).
- •Able to provide written informed consent.
- •Serum creatinine within normal laboratory range, as measured within 30 days of the baseline study endoscopy.
- •For females of reproductive potential: willing to use highly effective contraception while taking study medication and for an additional 5 days after completing study medication.
排除标准
- •Diagnosed with acute pancreatitis requiring hospitalization within the 6 weeks prior to study enrollment.
- •Habitual use of aspirin or non-steroidal anti-inflammatory medications (NSAIDs), defined as use more than once per week.
- •Any use of aspirin or NSAIDs within 1 week of baseline study endoscopy procedure.
- •Allergy to secretin, indomethacin or NSAIDs.
- •History of known chronic renal insufficiency or cirrhosis.
- •History of coronary artery disease, angina pectoris, myocardial infarction, cerebrovascular accident (stroke), or transient ischemic accident (TIA).
- •History of peptic ulcer or gastrointestinal bleeding.
- •Incarcerated.
- •Found to have active GI ulceration at the time of baseline endoscopy.
- •Hospitalized for acute pancreatitis while participating in this research protocol. Participants who are hospitalized for an episode of acute pancreatitis during study participation will be withdrawn from the study, and considered non-accrued.
研究组 & 干预措施
Indomethacin
The study intervention is oral indomethacin. Indomethacin is an FDA approved, commonly prescribed non-steroidal anti-inflammatory drug (NSAID). Commercially available indomethacin will be utilized in this study. Subjects randomized to the indomethacin arm will take one capsule of 50 mg of Indomethacin orally twice a day for 28 days. Participants will be advised not to make up missed doses. They will be advised to take a dose of study medication on the morning of their follow-up endoscopy, 2 hours prior to their scheduled procedure time, with a sip of water. At the time of follow-up endoscopy they will return any unused study medications.
干预措施: Indomethacin (Drug)
Indomethacin
The study intervention is oral indomethacin. Indomethacin is an FDA approved, commonly prescribed non-steroidal anti-inflammatory drug (NSAID). Commercially available indomethacin will be utilized in this study. Subjects randomized to the indomethacin arm will take one capsule of 50 mg of Indomethacin orally twice a day for 28 days. Participants will be advised not to make up missed doses. They will be advised to take a dose of study medication on the morning of their follow-up endoscopy, 2 hours prior to their scheduled procedure time, with a sip of water. At the time of follow-up endoscopy they will return any unused study medications.
干预措施: Endoscopy for Pancreatic Function Testing (Procedure)
Placebo
Participants in both study arms will receive study medication, one capsule orally twice a day for 28 days. Those in the placebo arm will take placebo capsules (one capsule) twice a day for a total of 28 days.
Participants will be advised not to make up missed doses. They will be advised to take a dose of study medication on the morning of their follow-up endoscopy, 2 hours prior to their scheduled procedure time, with a sip of water. At the time of follow-up endoscopy they will return any unused study medication.
干预措施: Placebo (Drug)
Placebo
Participants in both study arms will receive study medication, one capsule orally twice a day for 28 days. Those in the placebo arm will take placebo capsules (one capsule) twice a day for a total of 28 days.
Participants will be advised not to make up missed doses. They will be advised to take a dose of study medication on the morning of their follow-up endoscopy, 2 hours prior to their scheduled procedure time, with a sip of water. At the time of follow-up endoscopy they will return any unused study medication.
干预措施: Endoscopy for Pancreatic Function Testing (Procedure)
结局指标
主要结局
Change in Prostaglandin E2 (PGE2) Concentrations
时间窗: Baseline, 28 days
Mean change in PGE2 concentrations in pancreas fluid before and after intervention
次要结局
- Change in Pain Composite Score(Baseline, 28 days)
- Changes in Pain Interference Score(Baseline, 28 days)
- Change in Quality of Life (Mental Health)(Baseline, 28 days)
- Change in Quality of Life (Physical Health)(Baseline, 28 days)
研究者
Santhi Swaroop Vege
Principal Investigator
Mayo Clinic