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Last Updated: December 8, 2019

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CLINICAL TRIALS PROFILE FOR CELESTONE SOLUSPAN

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505(b)(2) Clinical Trials for CELESTONE SOLUSPAN

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 Recruiting 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 SOLUSPAN

Trial ID Title Status Sponsor Phase Start Date Summary
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.
NCT01222247 Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 3 2010-10-01 Infants born between 34 and 36 weeks of gestation, known as 'late preterm', are more likely to be admitted to a special care nursery, and more likely to suffer respiratory complications than infants born at term. The use of antenatal corticosteroids has been shown to improve lung function in very premature infants, but has not been evaluated in those likely to deliver in the late preterm period. This research study will attempt to answer the following primary research question: Do steroids, compared to no steroids, decrease babies' need for oxygen support when given to pregnant women at least 12 to 24 hours before they deliver at 34 weeks to 36 weeks gestation? The research study will also collect information on whether steroids improve the chances that the baby will not get sick from other causes.
NCT01222247 Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 2010-10-01 Infants born between 34 and 36 weeks of gestation, known as 'late preterm', are more likely to be admitted to a special care nursery, and more likely to suffer respiratory complications than infants born at term. The use of antenatal corticosteroids has been shown to improve lung function in very premature infants, but has not been evaluated in those likely to deliver in the late preterm period. This research study will attempt to answer the following primary research question: Do steroids, compared to no steroids, decrease babies' need for oxygen support when given to pregnant women at least 12 to 24 hours before they deliver at 34 weeks to 36 weeks gestation? The research study will also collect information on whether steroids improve the chances that the baby will not get sick from other causes.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for CELESTONE SOLUSPAN

Condition Name

Condition Name for CELESTONE SOLUSPAN
Intervention Trials
Familial Amyotrophic Lateral Sclerosis 1
Thumb Carpometacarpal Joint Osteoarthritis 1
Botulinum Toxins, Type A 1
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Condition MeSH

Condition MeSH for CELESTONE SOLUSPAN
Intervention Trials
Osteoarthritis 2
Motor Neuron Disease 1
Amyotrophic Lateral Sclerosis 1
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Clinical Trial Locations for CELESTONE SOLUSPAN

Trials by Country

Trials by Country for CELESTONE SOLUSPAN
Location Trials
United States 16
Mexico 1
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Trials by US State

Trials by US State for CELESTONE SOLUSPAN
Location Trials
California 2
Kentucky 1
Utah 1
Texas 1
Rhode Island 1
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Clinical Trial Progress for CELESTONE SOLUSPAN

Clinical Trial Phase

Clinical Trial Phase for CELESTONE SOLUSPAN
Clinical Trial Phase Trials
Phase 3 1
Phase 1 1
N/A 1
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Clinical Trial Status

Clinical Trial Status for CELESTONE SOLUSPAN
Clinical Trial Phase Trials
Recruiting 2
Completed 1
Not yet recruiting 1
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Clinical Trial Sponsors for CELESTONE SOLUSPAN

Sponsor Name

Sponsor Name for CELESTONE SOLUSPAN
Sponsor Trials
Loma Linda University 1
Universidad Autonoma de Nuevo Leon 1
The George Washington University Biostatistics Center 1
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Sponsor Type

Sponsor Type for CELESTONE SOLUSPAN
Sponsor Trials
Other 5
NIH 2
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