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Vitamin D Analogue

Paricalcitol for Chronic Pancreatitis (ALLIANCE Trial)

Phase < 1
Recruiting
Led By Stephen Pandol, MD
Research Sponsored by Cedars-Sinai Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of study (12 months)

Summary

This trial tested a new drug to see if it could help patients with Chronic Pancreatitis.

Who is the study for?
Adults aged 18-75 with Chronic Pancreatitis not caused by gallstones, medications, trauma or autoimmune issues can join. They must be able to take oral meds, have normal calcium/phosphate/parathyroid levels, and use effective contraception if of reproductive potential. Exclusions include organ transplant history, HIV/AIDS, MRI intolerance, certain pancreas-related conditions or surgeries.
What is being tested?
The trial is testing the safety and acceptability of paricalcitol for treating Chronic Pancreatitis compared to a placebo. Participants will receive either the actual drug or a dummy pill without any therapeutic effect to see if there's an improvement in their condition.
What are the potential side effects?
While specific side effects are not listed here for paricalcitol in this context, common ones may include high blood calcium levels (hypercalcemia), nausea, vomiting and possibly affecting kidney function.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of study (12 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of study (12 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Examine the feasibility of testing the effect of paricalcitol on health-related quality of life in patients with chronic pancreatitis
Secondary study objectives
Compare the mean change in health related quality of life from baseline across the times points 6 and 12 months between the treatment group and placebo

Side effects data

From 2010 Phase 4 trial • 109 Patients • NCT01265615
23%
Hypophospatemia
17%
Fatigue
13%
Increased hypertension
13%
Edema
13%
Diarrhea
13%
Pain
10%
Taste perversions
10%
Arthritis
10%
Dizziness
10%
Gastroenteritis
10%
Vertigo
10%
Rhinitis
10%
Bronchitis
10%
Rash
7%
Leg Cramps
7%
Viral Infection
7%
Hypercalcemia
7%
Allergic Infection
7%
Polydipsia
7%
Dehydration
7%
Urinary Tract Infection
3%
Chest Pain
3%
Sinusitis
3%
Headache
3%
General Infection
3%
Asthenia
3%
Fever
3%
Infection Fungal
3%
Conjuctivitis
3%
Syncope
3%
Depression
3%
Increased Cough
3%
Polyuria
3%
Abdominal Pain
3%
Photophobia
3%
Decreased libido
3%
Hypotension
3%
Nausea
3%
Esophageal ulcer
3%
Somnolence
3%
Back Pain
3%
Vomiting
3%
Pruritus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Paricalcitol Treatment
Calcitriol Treatment
Cholecalciferol
Supplemental

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ParicalcitolExperimental Treatment1 Intervention
Participants receive Paricalcitol 2mcg capsule once daily for 12 months.
Group II: PlaceboPlacebo Group1 Intervention
Participants receive Paricalcitol Placebo capsule matching Paricalcitol once daily for 12 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paricalcitol
2013
Completed Phase 4
~1730

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor
511 Previous Clinical Trials
163,280 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,443 Previous Clinical Trials
4,331,120 Total Patients Enrolled
Stephen Pandol, MDPrincipal InvestigatorCedars-Sinai Medical Center
1 Previous Clinical Trials
36 Total Patients Enrolled

Media Library

Paricalcitol (Vitamin D Analogue) Clinical Trial Eligibility Overview. Trial Name: NCT05664880 — Phase < 1
Chronic Pancreatitis Research Study Groups: Paricalcitol, Placebo
Chronic Pancreatitis Clinical Trial 2023: Paricalcitol Highlights & Side Effects. Trial Name: NCT05664880 — Phase < 1
Paricalcitol (Vitamin D Analogue) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05664880 — Phase < 1
~3 spots leftby Mar 2025
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