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Last Updated: November 2, 2024

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 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 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 Active, not recruiting Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 3 2010-10-01 This is a randomized placebo controlled trial to evaluate whether antenatal corticosteroids can decrease the rate of neonatal respiratory support, thus decreasing the rate of NICU admissions and improving short-term outcomes in the late preterm infant. The use of antenatal corticosteroids has been shown to be beneficial in women at risk for preterm delivery prior to 34 weeks but has not been evaluated in those likely to deliver in the late preterm period
NCT01222247 ↗ Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial Active, not recruiting National Heart, Lung, and Blood Institute (NHLBI) Phase 3 2010-10-01 This is a randomized placebo controlled trial to evaluate whether antenatal corticosteroids can decrease the rate of neonatal respiratory support, thus decreasing the rate of NICU admissions and improving short-term outcomes in the late preterm infant. The use of antenatal corticosteroids has been shown to be beneficial in women at risk for preterm delivery prior to 34 weeks but has not been evaluated in those likely to deliver in the late preterm period
NCT01222247 ↗ Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial Active, not recruiting The George Washington University Biostatistics Center Phase 3 2010-10-01 This is a randomized placebo controlled trial to evaluate whether antenatal corticosteroids can decrease the rate of neonatal respiratory support, thus decreasing the rate of NICU admissions and improving short-term outcomes in the late preterm infant. The use of antenatal corticosteroids has been shown to be beneficial in women at risk for preterm delivery prior to 34 weeks but has not been evaluated in those likely to deliver in the late preterm period
NCT03054610 ↗ Therapeutic Effect of Botulinum Toxin A for the Treatment of Plantar Fasciitis. Completed Universidad Autonoma de Nuevo Leon Phase 1 2015-01-01 Plantar fasciitis is the most common cause of plantar heel pain and is commonly present in people 40 years of age or older, overweight, sedentary or with intense physical activity. It is caused by the over-stretching of the plantar fascia, which is a band of connective tissue that extends to the base of the phalanges. This produces micro-tears more commonly in its origin in the medial tuberosity of the calcaneus which causes an inflammatory process and pain. This pain usually occurs when the person gets up in the morning after sleeping or after sitting for a long time. That is when the fascia is stretched after being in a contraction position. There are a great variety of treatments for this pathology, of these, one of the most common is the use of intralesional steroids, which a weighing that reduces symptomatology in many cases also has undesirable effects such as subcutaneous fat atrophy, rupture of the plantar fascia, peripheral nerve injury, muscle damage and stress fractures. Other treatments are extracorporeal shock waves, application of platelet-rich plasma and application of botulinum toxin A intralesional. All of them are accompanied by insoles, night splints and stretching exercises of the Achilles tendon and the plantar fascia. Recent studies have shown that the application of botulinum toxin A intralesional in patients with plantar fasciitis helps to improve the symptomatology to decrease pain in both intensity and presentation time. Decreased inflammation of the plantar fascia has also been demonstrated. This is the sale of the usual form of action of the botulinum toxin, which is applied regularly in the muscles to block the release of acetylcholine in the neuromuscular plaque and obtain its relaxation and not directly in the pain points. We believe that the botulinum toxin can be applied intralesional currently, since there is information that the toxin has analgesic and anti-inflammatory effect and not just muscle relaxation. The aim of our work demonstrate that the use of botulinum toxin A and intralesional stretching exercises is superior to intralesional steroids and stretching trying to establish a safer and less painful therapy avoiding complications prior to the application of steroid application.
NCT03445611 ↗ Parabens Flocculation on the Anti Inflammatory Effects of Corticosteroid Injections for Total Knee Arthroplasty Withdrawn Loma Linda University Early Phase 1 2019-09-15 The purpose of this study is to identify whether corticosteroid use with anesthetics containing preservatives (parabens) reduces clinical effectiveness of the anti-inflammatory agent Up to 100 patients, both male and female, between the ages of 18-89 will be enrolled and randomized into either of the following groups; Group 1: These patients will receive a corticosteroid solution with lidocaine containing parabens. Group 2: These patients will receive corticosteroid solution with paraben free lidocaine.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for CELESTONE SOLUSPAN

Condition Name

Condition Name for CELESTONE SOLUSPAN
Intervention Trials
Osteoarthritis, Knee 2
Plantar Fascitis 1
Pregnancy 1
Pregnancy Outcome 1
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Condition MeSH

Condition MeSH for CELESTONE SOLUSPAN
Intervention Trials
Osteoarthritis 2
Osteoarthritis, Knee 2
Fasciitis, Plantar 1
Fasciitis 1
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Clinical Trial Locations for CELESTONE SOLUSPAN

Trials by Country

Trials by Country for CELESTONE SOLUSPAN
Location Trials
United States 17
Mexico 1
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Trials by US State

Trials by US State for CELESTONE SOLUSPAN
Location Trials
California 2
North Carolina 1
New York 1
Michigan 1
Illinois 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 4 1
Phase 3 1
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for CELESTONE SOLUSPAN
Clinical Trial Phase Trials
Completed 3
Withdrawn 1
Active, not recruiting 1
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Clinical Trial Sponsors for CELESTONE SOLUSPAN

Sponsor Name

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

Sponsor Type for CELESTONE SOLUSPAN
Sponsor Trials
Other 7
NIH 2
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