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Last Updated: January 21, 2020

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CLINICAL TRIALS PROFILE FOR DURACLON

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All Clinical Trials for Duraclon

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00510016 Clonidine as Adjunct Therapy for the Treatment of Neonatal Abstinence Syndrome Completed Johns Hopkins University Phase 2 2002-07-01 To test the hypothesis that the combination of the tincture of opium (DTO) and clonidine will be more effective in treating infants with neonatal abstinence syndrome (opioid withdrawal) than tincture of opium (DTO) alone.
NCT00510016 Clonidine as Adjunct Therapy for the Treatment of Neonatal Abstinence Syndrome Completed National Institute on Drug Abuse (NIDA) Phase 2 2002-07-01 To test the hypothesis that the combination of the tincture of opium (DTO) and clonidine will be more effective in treating infants with neonatal abstinence syndrome (opioid withdrawal) than tincture of opium (DTO) alone.
NCT00678379 Pediatric Tonsillectomy Pain Reduction Study Completed Vanderbilt University Medical Center Phase 3 2008-04-01 Tonsillectomy is associated with a significant decrease quality of life in children secondary to pain, which is worsened with swallowing. Previous studies in the pediatric population have demonstrated a significant decrease in post-operative pain/morbidity when administering pain reduction medications into the tonsillar fossa prior to removal. While these studies have shown great promise, no large randomized trial of the most promising medications has been conducted. Because of this, many otolaryngologists do not administer intra-operative medications aimed at reducing post-operative pain. The objective of the current study is to conduct a prospective, double-blind, placebo-controlled, randomized clinical trial using a pre-tonsillectomy infiltration of the tonsillar fossa comparing three treatment regimens in reducing post-tonsillectomy morbidity (i.e. pain, poor oral intake): 1) Placebo (saline injection) 2) bupivacaine (0.5%) + lidocaine (1%), 3) bupivacaine (0.5%) + lidocaine (1%) + clonidine (25 µg).
NCT01360450 Clonidine to Treat Iatrogenic-induced Opioid Dependence in Infants Terminated National Institute on Drug Abuse (NIDA) Phase 2/Phase 3 2011-07-01 Thousands of critically ill infants (and children) are exposed to opioids and benzodiazepines to achieve sedation and analgesia as part of routine care in neonatal and pediatric intensive care units. While the use of these agents are undisputedly beneficial in reducing pain and anxiety, improving ventilation, reducing pulmonary vascular resistance and improving outcomes; the consequence is often the development of tolerance and physiologic dependence - similar to prenatal exposure from these same classes of drugs. The investigators have recently reported the results of randomized placebo control trial showing that the addition of clonidine (central alpha 2 agonist) to tapering doses of opioids was efficacious and safe in treating opioid dependence in infants who had moderate to severe neonatal abstinence syndrome from prenatal drug exposure to opioids. Currently, the investigators propose to perform a double-blind, randomized placebo control trial in a cohort of critically ill infants without prenatal drug exposure at Johns Hopkins Hospital to test the overall hypothesis that early addition of clonidine to a cohort of critically ill neonates on mechanical ventilation who are receiving opioids and benzodiazepines for analgesia and sedation will be efficacious and safe in reducing both the incidence and severity of withdrawal symptoms (NICU-NAS); as well as, reducing the time to complete sedative and analgesic drug detoxification. The hypothesis will be tested by addressing 2 specific aims that will determine: 1) the efficacy and safety of clonidine in critically ill infants, and 2) pharmacokinetics and pharmacodynamics using population-based pharmacokinetics in this vulnerable infant population who have only been exposed to these drugs as part of their routine care. Many "standard of care practices" are incorporated in neonatal and pediatric care prior to evidence based studies. This proposal will fill a much needed gap in translating what the investigators have learned about basic mechanisms mediating dependence and withdrawal to proven therapies for vulnerable pediatric populations.
NCT01360450 Clonidine to Treat Iatrogenic-induced Opioid Dependence in Infants Terminated Gauda, Estelle B., M.D. Phase 2/Phase 3 2011-07-01 Thousands of critically ill infants (and children) are exposed to opioids and benzodiazepines to achieve sedation and analgesia as part of routine care in neonatal and pediatric intensive care units. While the use of these agents are undisputedly beneficial in reducing pain and anxiety, improving ventilation, reducing pulmonary vascular resistance and improving outcomes; the consequence is often the development of tolerance and physiologic dependence - similar to prenatal exposure from these same classes of drugs. The investigators have recently reported the results of randomized placebo control trial showing that the addition of clonidine (central alpha 2 agonist) to tapering doses of opioids was efficacious and safe in treating opioid dependence in infants who had moderate to severe neonatal abstinence syndrome from prenatal drug exposure to opioids. Currently, the investigators propose to perform a double-blind, randomized placebo control trial in a cohort of critically ill infants without prenatal drug exposure at Johns Hopkins Hospital to test the overall hypothesis that early addition of clonidine to a cohort of critically ill neonates on mechanical ventilation who are receiving opioids and benzodiazepines for analgesia and sedation will be efficacious and safe in reducing both the incidence and severity of withdrawal symptoms (NICU-NAS); as well as, reducing the time to complete sedative and analgesic drug detoxification. The hypothesis will be tested by addressing 2 specific aims that will determine: 1) the efficacy and safety of clonidine in critically ill infants, and 2) pharmacokinetics and pharmacodynamics using population-based pharmacokinetics in this vulnerable infant population who have only been exposed to these drugs as part of their routine care. Many "standard of care practices" are incorporated in neonatal and pediatric care prior to evidence based studies. This proposal will fill a much needed gap in translating what the investigators have learned about basic mechanisms mediating dependence and withdrawal to proven therapies for vulnerable pediatric populations.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Duraclon

Condition Name

Condition Name for Duraclon
Intervention Trials
Neonatal Abstinence Syndrome 2
Total Knee Arthroplasty 1
Postoperative Pain 1
Pain Management 1
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Condition MeSH

Condition MeSH for Duraclon
Intervention Trials
Neonatal Abstinence Syndrome 2
Hypothermia 1
Brain Ischemia 1
Brain Diseases 1
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Clinical Trial Locations for Duraclon

Trials by Country

Trials by Country for Duraclon
Location Trials
United States 5
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Trials by US State

Trials by US State for Duraclon
Location Trials
Maryland 4
Tennessee 1
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Clinical Trial Progress for Duraclon

Clinical Trial Phase

Clinical Trial Phase for Duraclon
Clinical Trial Phase Trials
Phase 4 1
Phase 3 1
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Duraclon
Clinical Trial Phase Trials
Completed 2
Recruiting 1
Terminated 1
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Clinical Trial Sponsors for Duraclon

Sponsor Name

Sponsor Name for Duraclon
Sponsor Trials
Gauda, Estelle B., M.D. 2
National Institute on Drug Abuse (NIDA) 2
Estelle B. Gauda, MD 1
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Sponsor Type

Sponsor Type for Duraclon
Sponsor Trials
Other 8
NIH 2
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