BridgeMD
New treatment option for Chronic Pancreatitis
Official title A PiLot ClinicaL TrIal of ParicAlcitol for ChroNiC PancrEatitis
ClinicalTrials.gov ID: NCT05664880
What this study is testing
What is Paricalcitol?
Paricalcitol is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for chronic pancreatitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this pilot study to examine the feasibility and acceptability of paricalcitol in adults with Chronic Pancreatitis (CP).
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18-75 at time of enrollment
- Diagnosis of Chronic Pancreatitis episode is not attributable to gallstones (i.e. suspected or definite biliary etiology), medications, trauma or...
- Ability to take oral medication and be willing to adhere to the dosing regimen
You likely can't join if
- Pregnancy or lactation
- History of autoimmune or traumatic pancreatitis, or sentinel attack of acute necrotizing pancreatitis which results in suspected disconnected duct...
- Primary pancreatic tumors - pancreatic ductal adenocarcinoma, suspected cystic neoplasm (\>1 cms in size or main duct involvement), neuroendocrine...
- Pancreatic metastasis from other malignancies
- History of solid organ transplant, HIV/AIDS.
- Abnormal lab values: calcium, phosphate, or parathyroid hormone
See the full eligibility criteria
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18-75 at time of enrollment
- Diagnosis of Chronic Pancreatitis episode is not attributable to gallstones (i.e. suspected or definite biliary etiology), medications, trauma or autoimmune pancreatitis.
- Ability to take oral medication and be willing to adhere to the dosing regimen
- Normal Calcium levels- 8.5 to 10.2 mg/dL
- Normal Phosphate levels- 2.8 to 4.5 mg/dL
- Normal Parathyroid hormone levels- 10 to 65 pg/mL
- For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 1 week after the...
- For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner
- No prior pancreatic surgery
- Pancreatic necrosis, if present, is \<50% (to be verified by radiologist)
- No involvement in any treatment trials currently or within 6 months of enrollment
- Pregnancy or lactation
- History of autoimmune or traumatic pancreatitis, or sentinel attack of acute necrotizing pancreatitis which results in suspected disconnected duct syndrome
- Primary pancreatic tumors - pancreatic ductal adenocarcinoma, suspected cystic neoplasm (\>1 cms in size or main duct involvement), neuroendocrine tumors, and other uncommon tumors.
- Pancreatic metastasis from other malignancies
- History of solid organ transplant, HIV/AIDS.
- Abnormal lab values: calcium, phosphate, or parathyroid hormone
- Known isolated pancreatic exocrine insufficiency (e.g. in the absence of any eligible inclusion criteria)
- Participants must not have medical or psychiatric illnesses or ongoing substance abuse that in the investigator's opinion would compromise their ability to tolerate study interventions or participate in longitudinal...
- Patients with known abnormal creatinine (GFR \< 30) or renal failure (applies to patients with chronic upper abdominal pain of suspected pancreatic origin and suspected CP.
- Known Pregnancy. All participants of childbearing potential, except if post-menopausal [i.e. no menses for ≥2 years] or had a hysterectomy, bilateral tubal ligation/clip (surgical sterilization) or surgical removal of...
- Currently incarcerated
- Inability to tolerate MRI
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
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 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.