36 Participants Needed

ARAT for Acid Reflux

(AREA21 Trial)

CC
AH
Overseen ByApril Higbee, BSN
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Midwest Veterans' Biomedical Research Foundation
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This will be a randomized clinical trial examining the efficacy and safety of ARAT (intervention group) in patients with chronic GERD symptoms (typical symptoms of GERD, i.e. heartburn or acid reflux/regurgitation at least twice a week) for the last 6 months.Patients must have a positive pH test and a negative manometry (no treatment) procedure.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is ARAT treatment generally safe for humans?

ARAT treatments like abiraterone, enzalutamide, apalutamide, and darolutamide have been used for prostate cancer and can cause side effects like changes in hormone levels, muscle loss, and effects on the brain. However, these treatments are generally considered safe for use in humans, with side effects being monitored and managed by healthcare providers.12345

Who Is on the Research Team?

Prateek Sharma, MD, FASGE, ASGE President

Prateek Sharma, MD

Principal Investigator

Kansas City VA Hospital

MD

Madhav Desai, MD

Principal Investigator

Kansas City VA Hospital

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with chronic GERD, experiencing heartburn or acid reflux at least twice a week for the past 6 months. They must have confirmed acid reflux via a pH test but no major esophagus movement issues. Excluded are those with certain esophageal conditions, previous surgeries, severe liver disease, allergies to PPIs, and very large hiatal hernias.

Inclusion Criteria

Objective evidence of reflux disease (positive ambulatory pH study)
I have had heartburn or acid reflux at least twice a week for the last 6 months.

Exclusion Criteria

Allergic or intolerant to PPI medications
I have a large hiatal hernia over 3 cm and it's very severe.
Gastroparesis documented by abnormal gastric emptying time
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive anti-reflux mucosal ablation using hybrid argon plasma coagulation

12 months
Multiple visits (in-person) at 3, 6, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months
Follow-up assessments at 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

  • ARAT
  • Sham intervention (control)
Trial Overview The AREA Study is testing ARAT's effectiveness in treating chronic GERD symptoms against a sham (fake) procedure as control. Participants will be randomly assigned to either receive ARAT or the sham intervention to compare outcomes.
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: Anti-reflux mucosal ablation (ARAT)Active Control1 Intervention
Group II: No treatmentPlacebo Group1 Intervention

ARAT is already approved in United States, European Union, Japan, Canada for the following indications:

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Approved in United States as Abiraterone for:
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Approved in European Union as Enzalutamide for:
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Approved in Japan as Apalutamide for:
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Approved in Canada as Darolutamide for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Midwest Veterans' Biomedical Research Foundation

Lead Sponsor

Trials
1
Recruited
40+

Published Research Related to This Trial

In a study of 55 patients with metastatic hormone-naive prostate cancer, no significant differences in muscle loss were observed between those receiving androgen deprivation therapy (ADT) alone or in combination with either abiraterone or enzalutamide.
Despite the lack of difference between treatment groups, all patients experienced decreases in skeletal muscle mass, emphasizing the need for strategies to preserve muscle during ADT for prostate cancer.
A comparison of the sarcopenic effect of androgen receptor-axis-targeted agents vs. androgen deprivation alone in patients with metastatic prostate cancer.Lawen, T., Masoumi-Ravandi, K., Rendon, RA., et al.[2023]
In a comparison of darolutamide with apalutamide and enzalutamide for treating nonmetastatic castration-resistant prostate cancer, no differences in metastasis-free survival were found, indicating similar efficacy among the treatments.
Darolutamide demonstrated a better safety profile, with significantly lower rates of falls, fractures, and rashes compared to apalutamide, and lower rates of dizziness and fatigue compared to enzalutamide, suggesting it may be a preferable option for patients.
Indirect Comparison of Darolutamide versus Apalutamide and Enzalutamide for Nonmetastatic Castration-Resistant Prostate Cancer.Halabi, S., Jiang, S., Terasawa, E., et al.[2021]
ARAT agents like abiraterone acetate and enzalutamide improve survival rates in advanced prostate cancer but are associated with significant endocrine and metabolic side effects, such as hypertension and insulin resistance.
Darolutamide appears to have a safer side effect profile compared to other ARAT agents, suggesting that treatment for advanced prostate cancer should be personalized based on individual patient safety and risk factors.
Endocrine consequences of treatment with the new androgen receptor axis-targeted agents for advanced prostate cancer.Pyrgidis, N., Vakalopoulos, I., Sountoulides, P.[2021]

Citations

A comparison of the sarcopenic effect of androgen receptor-axis-targeted agents vs. androgen deprivation alone in patients with metastatic prostate cancer. [2023]
Indirect Comparison of Darolutamide versus Apalutamide and Enzalutamide for Nonmetastatic Castration-Resistant Prostate Cancer. [2021]
Endocrine consequences of treatment with the new androgen receptor axis-targeted agents for advanced prostate cancer. [2021]
Managing lines of therapy in castration-resistant prostate cancer: real-life snapshot from a multicenter cohort. [2021]
Comparison of Cerebral Blood Flow in Regions Relevant to Cognition After Enzalutamide, Darolutamide, and Placebo in Healthy Volunteers: A Randomized Crossover Trial. [2023]
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