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Generated: December 14, 2018

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CLINICAL TRIALS PROFILE FOR DURACLON

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Clinical Trials for Duraclon

Trial ID Title Status Sponsor Phase Summary
NCT00510016 Clonidine as Adjunct Therapy for the Treatment of Neonatal Abstinence Syndrome Completed Johns Hopkins University Phase 2 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 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 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 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 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.
NCT01862250 Safety of Clonidine in Infants With Hypoxic Ischemic Encephalopathy During Therapeutic Hypothermia Active, not recruiting University of Maryland Phase 1/Phase 2 This research is being done to find out the safety of the investigational study drug,clonidine, in infants who are undergoing whole body cooling for the treatment of hypoxic ischemic encephalopathy (HIE). HIE is the damage that occurs to the cells of the central nervous system (brain and spinal cord) as a result of decreased oxygen supply and blood flow to the fetus due to perinatal asphyxia (inadequate oxygen to the baby during the birth process). HIE is a significant cause of morbidity and mortality in infants. The only known and effective treatment for HIE is therapeutic hypothermia or whole body cooling for72 hours. During the cooling process babies get agitated, shiver and are uncomfortable. To treat these side effects sedative-analgesic medications like morphine are frequently used. Clonidine (Clon), which is another class of sedative-analgesic can be used for the similar purpose but is more effective than morphine in decreasing shivering in adults and children. Furthermore, in some preclinical studies, clonidine has been shown to be neuroprotective (safe for the brain in models of brain injury). Clon (Duraclon®) has been approved by the Food and Drug Administration (FDA)for the treatment of pain in certain cancer patients. It is not approved for treating side effects of therapeutic hypothermia in infants and its use in this study is considered investigational. FDA is allowing for us to use clonidine for this Phase I-II study. In this kind of study clonidine will be started at low dose and slowly increased do determine at what dose the shivering is controlled and the use of clonidine is not associated with any side effects. This means that not all babies in the study will get the same dose of Clon. Doses at the beginning of the study will be lower than doses at the end of the study. Because of the design of the study, some babies may get doses that are too low to have an effect, and other babies will probably might get a doses that could cause side effects. In this Phase I-II study, the investigators will determine the (i) the maximum tolerated dose of clonidine during cooling for HIE, (ii) the effects of clonidine on heart rate, blood pressure, core body temperature and cerebral autoregulation (ability to maintain constant blood flow in the face of blood pressure changes) and (iii) association between blood levels and changes in the above parameters. In this study the investigators hope to find ways to improve sedation, shivering and agitation in newborn infants with HIE on the cooling protocol. Our ultimate goal is determine the potential neuro-protective properties of clonidine in newborn babies with HIE.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Duraclon

Condition Name

Condition Name for Duraclon
Intervention Trials
Neonatal Abstinence Syndrome 2
Postoperative Pain 1
Pain Management 1
Mechanical Ventilation Complication 1
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Condition MeSH

Condition MeSH for Duraclon
Intervention Trials
Neonatal Abstinence Syndrome 2
Brain Ischemia 1
Brain Diseases 1
Pain, Postoperative 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
University of Maryland 1
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Sponsor Type

Sponsor Type for Duraclon
Sponsor Trials
Other 8
NIH 2
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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Colorcon
Covington
Citi
Johnson and Johnson
US Army
Argus Health
Cantor Fitzgerald
Cipla

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