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Last Updated: March 29, 2024

CLINICAL TRIALS PROFILE FOR CELESTONE


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505(b)(2) Clinical Trials for CELESTONE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT03707795 ↗ Treatment of FUS-Related ALS With Betamethasone - The TRANSLATE Study Completed Edward Kasaraskis Early Phase 1 2017-08-21 By doing this study the investigator hopes to learn more about a potential cause of amyotrophic lateral sclerosis (ALS) called "oxidative stress". Oxidative stress is essentially an imbalance between the production of certain chemicals in the body called "free radicals" and the ability of the body to counteract or detoxify their harmful effects through neutralization by antioxidants. It is thought that factors such as environmental exposure (chemicals and lead), diet, smoking,alcohol consumption, physical activity and psychological stress cause oxidative stress to occur inside the body. By doing this study, the investigator hopes to learn whether the FDA-approved steroid medication called Betamethasone will restore overall antioxidant activity fALS patients with mutations in the Fused in Sarcoma gene (FUS gene). Participants who agree to take part in this research study, agree to the following responsibilities: - Attend all scheduled visits - Notify the study doctor of any illnesses, unexpected or troublesome side effects, or any other medical problems that occur during the study - Be completely honest with their answers to all questions - Check with the study doctor before taking any new medications, whether prescribed or "over the counter," even vitamins and herbal supplements.
OTC NCT03707795 ↗ Treatment of FUS-Related ALS With Betamethasone - The TRANSLATE Study Completed University of Kentucky Early Phase 1 2017-08-21 By doing this study the investigator hopes to learn more about a potential cause of amyotrophic lateral sclerosis (ALS) called "oxidative stress". Oxidative stress is essentially an imbalance between the production of certain chemicals in the body called "free radicals" and the ability of the body to counteract or detoxify their harmful effects through neutralization by antioxidants. It is thought that factors such as environmental exposure (chemicals and lead), diet, smoking,alcohol consumption, physical activity and psychological stress cause oxidative stress to occur inside the body. By doing this study, the investigator hopes to learn whether the FDA-approved steroid medication called Betamethasone will restore overall antioxidant activity fALS patients with mutations in the Fused in Sarcoma gene (FUS gene). Participants who agree to take part in this research study, agree to the following responsibilities: - Attend all scheduled visits - Notify the study doctor of any illnesses, unexpected or troublesome side effects, or any other medical problems that occur during the study - Be completely honest with their answers to all questions - Check with the study doctor before taking any new medications, whether prescribed or "over the counter," even vitamins and herbal supplements.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for CELESTONE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00370799 ↗ Effectiveness of Caudal Epidural Injections in Treatment of Chronic Low Back and Lower Extremity Pain Completed Pain Management Center of Paducah Early Phase 1 2007-01-01 To demonstrate clinically significant improvements or lack thereof in the caudal epidural patients with our without steroids. To evaluate differences in outcomes in patients receiving steroids compared to those patients randomized to the local anesthetic group who did not receive steroids. To assess improvements among patients and compare steroid groups with each other and local anesthetic group. To evaluate and compare the adverse event profile in all patients
NCT00669383 ↗ Rescue Antenatal Steroids and Pulmonary Function Tests in Preterm Infants Completed American Lung Association N/A 2001-06-01 One course of steroids given to a mother before a premature delivery helps the lungs of the premature infant and decreases breathing problems. One course of antenatal steroids is the standard of care for threatened premature deliveries. It is unclear as to how long the benefit of one course of steroids last. The most benefit to the baby's lungs seem to occur if the steroids are given at least 24 hours before but within 7 days of a premature delivery. It is difficult to predict the timing of a preterm delivery so deliveries often do not occur within this time period. We hypothesize that the benefits of the steroids to the lungs wear off if the steroids are given more than 14 days before a preterm delivery, and that in these circumstances an extra course of steroids will help the premature baby's lungs and the premature baby will have less breathing problems as shown by lung function testing.
NCT00669383 ↗ Rescue Antenatal Steroids and Pulmonary Function Tests in Preterm Infants Completed Oregon Health and Science University N/A 2001-06-01 One course of steroids given to a mother before a premature delivery helps the lungs of the premature infant and decreases breathing problems. One course of antenatal steroids is the standard of care for threatened premature deliveries. It is unclear as to how long the benefit of one course of steroids last. The most benefit to the baby's lungs seem to occur if the steroids are given at least 24 hours before but within 7 days of a premature delivery. It is difficult to predict the timing of a preterm delivery so deliveries often do not occur within this time period. We hypothesize that the benefits of the steroids to the lungs wear off if the steroids are given more than 14 days before a preterm delivery, and that in these circumstances an extra course of steroids will help the premature baby's lungs and the premature baby will have less breathing problems as shown by lung function testing.
NCT00685880 ↗ Prolotherapy Versus Steroids for Thumb Carpo-metacarpal Joint Arthritis Terminated Mayo Clinic N/A 2008-05-01 Arthritis of the base of the thumb is a common debilitating problem. It is believed that laxity (loosening) of the joint leads to worsening arthritis in this joint. This can be treated by securing the joint surgically or symptoms can be treated with hand therapy and/or injection of corticosteroids. Recently prolotherapy (sugar water) has been shown to decrease looseness of joints and also be helpful for hand and knee arthritis. We hypothesize that prolotherapy injections for thumb arthritis will be equally or more beneficial to the patients than steroids.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for CELESTONE

Condition Name

Condition Name for CELESTONE
Intervention Trials
Osteoarthritis, Knee 2
Low Back Pain 2
Respiratory Compliance 1
Diabetes Mellitus 1
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Condition MeSH

Condition MeSH for CELESTONE
Intervention Trials
Back Pain 3
Osteoarthritis, Knee 3
Osteoarthritis 3
Low Back Pain 2
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Clinical Trial Locations for CELESTONE

Trials by Country

Trials by Country for CELESTONE
Location Trials
United States 19
Canada 9
Australia 6
Greece 1
Spain 1
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Trials by US State

Trials by US State for CELESTONE
Location Trials
California 3
Kentucky 3
Pennsylvania 2
Oregon 2
North Carolina 2
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Clinical Trial Progress for CELESTONE

Clinical Trial Phase

Clinical Trial Phase for CELESTONE
Clinical Trial Phase Trials
Phase 4 9
Phase 3 1
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for CELESTONE
Clinical Trial Phase Trials
Completed 9
Not yet recruiting 4
Recruiting 2
[disabled in preview] 2
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Clinical Trial Sponsors for CELESTONE

Sponsor Name

Sponsor Name for CELESTONE
Sponsor Trials
Pain Management Center of Paducah 2
Oregon Health and Science University 2
University of Kentucky 1
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Sponsor Type

Sponsor Type for CELESTONE
Sponsor Trials
Other 29
Industry 1
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