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Vitamin D Analogue

Paricalcitol for Chronic Pancreatitis (ALLIANCE Trial)

Q: Does this research allow those under 35 years of age to participate?

This trial abides by the inclusion criteria of 18 being the lower age limit and 75 as the upper boundary for potential participants.

Q: Are there any vacancies left for volunteers in this experiment?

Unfortunately, the clinical trial is not currently accepting participants. It was initially posted on January 1st 2023 and last revised on December 16th 2022 according to information found on clinicaltrials.gov. Although this trial isn't recruiting now, 86 alternative studies are actively seeking volunteers at present.

Q: Does my eligibility criteria qualify me to participate in this clinical trial?

This clinical trial seeks 24 volunteers who suffer from chronic pancreatitis, are aged 18 to 75 and meet several criteria. These include providing written consent form, being willing to adhere to <a href="https://www.withpower.com/clinical-trials/all">all</a> study instructions, having normal calcium levels between 8.5 and 10.2 mg/dL, phosphate levels of 2.8-4.5 mg/dL, parathyroid hormone levels between 10 and 65 pg/mL as well as females using highly effective contraception for a month before screening while males use condoms or other forms of <a href="https://www.withpower.com/clinical-trials/birth-control">birth control</a> with partner(s).

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)

Awards & highlights

ALLIANCE Trial 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.Check my eligibility

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.See study design

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.

ALLIANCE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ end of study (12 months)

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Examine the feasibility of testing the effect of paricalcitol on health-related quality of life in patients with chronic pancreatitis

Secondary outcome measures

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

Viral Infection

Leg Cramps

Hypercalcemia

Allergic Infection

Polydipsia

Dehydration

Urinary Tract Infection

Chest Pain

Sinusitis

Headache

General Infection

Asthenia

Fever

Infection Fungal

Conjuctivitis

Syncope

Depression

Increased Cough

Polyuria

Abdominal Pain

Photophobia

Decreased libido

Hypotension

Nausea

Esophageal ulcer

Somnolence

Back Pain

Vomiting

Pruritus

100%

80%

60%

40%

20%

Study treatment Arm

Paricalcitol Treatment

Calcitriol Treatment

Cholecalciferol

Supplemental

ALLIANCE 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor

500 Previous Clinical Trials

164,839 Total Patients Enrolled

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,359 Previous Clinical Trials

4,314,568 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research allow those under 35 years of age to participate?

"This trial abides by the inclusion criteria of 18 being the lower age limit and 75 as the upper boundary for potential participants."

Answered by AI

Are there any vacancies left for volunteers in this experiment?

"Unfortunately, the clinical trial is not currently accepting participants. It was initially posted on January 1st 2023 and last revised on December 16th 2022 according to information found on clinicaltrials.gov. Although this trial isn't recruiting now, 86 alternative studies are actively seeking volunteers at present."

Answered by AI

Does my eligibility criteria qualify me to participate in this clinical trial?

"This clinical trial seeks 24 volunteers who suffer from chronic pancreatitis, are aged 18 to 75 and meet several criteria. These include providing written consent form, being willing to adhere to all study instructions, having normal calcium levels between 8.5 and 10.2 mg/dL, phosphate levels of 2.8-4.5 mg/dL, parathyroid hormone levels between 10 and 65 pg/mL as well as females using highly effective contraception for a month before screening while males use condoms or other forms of birth control with partner(s)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A PiLot ClinicaL TrIal of ParicAlcitol for ChroNiC PancrEatitis

Stephen Pandol, MD 2023. "A PiLot ClinicaL TrIal of ParicAlcitol for ChroNiC PancrEatitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05664880.

All > Chronic Pancreatitis