NEWS HIGHLIGHTS
Published Studies Related to Catapres-TTS (Clonidine Transdermal)
A randomized feasibility trial of clonidine to reduce perioperative cardiac risk
in patients on chronic beta-blockade: the EPIC study. [2014]
chronic beta-blockade... CONCLUSION: This pilot randomized trial confirmed the feasibility, safety, and
[Efficacy of clonidine transdermal patch for treatment of Tourette's syndrome in children] [2009.07]
OBJECTIVE: Children with Tourette's syndrome (TS) have a poor treatment compliance due to side effects and inconvenient administration of oral drugs. This study explored the efficacy and safety of clonidine transdermal patch for treating TS in children... CONCLUSIONS: Clonidine transdermal patch is effective for the treatment of TS in children and its side effects are mild and rare.
Randomized double-blind multicentre placebo-controlled clinical trial of the clonidine adhesive patch for the treatment of tic disorders. [2008.09]
CONCLUSIONS: The clonidine adhesive patch is effective and safe for tic disorders.
Clonidine for the treatment of supine hypertension and pressure natriuresis in autonomic failure. [2006.03]
Patients with autonomic failure are disabled by orthostatic hypotension, which can be worsened by the nighttime pressure natriuresis induced by associated supine hypertension... These results are consistent with residual sympathetic tone contributing to supine hypertension in autonomic failure, which can be targeted with clonidine to decrease BP and nocturnal natriuresis.
Opioid detoxification with buprenorphine, clonidine, or methadone in hospitalized heroin-dependent patients with HIV infection. [2003.04.01]
With the growing role of intravenous drug use in the transmission of HIV infection, HIV-infected patients frequently present with comorbid opioid dependence. Yet, few empirical evaluations of the efficacy and consequences of opioid detoxification medications in medically ill HIV-infected patients have been reported...
Clinical Trials Related to Catapres-TTS (Clonidine Transdermal)
Bioequivalence of Two Transdermal Clonidine Administrations in Healthy Volunteers [Completed]
To establish the bioequivalence and adhesion properties of transdermal clonidine prepared
with Oppanol® brands of polyisobutylene (PIB) vs. transdermal clonidine prepared with
VistanexTM brands of polyisobutylene (PIB) in healthy male and female volunteers.
Effect of Intrathecal Clonidine in Hypertensive Subjects With Poorly Controlled Blood Pressure [Completed]
The purpose of this study is to determine the acute efficacy of intrathecal clonidine to
reduce blood pressure in hypertensive subjects with poor blood pressure control and describe
its effects on cardiovascular function.
The Effect of Clonidine-enhanced Sedation on Delirium in Ventilated Critically Ill Patients [Not yet recruiting]
Rationale: Delirium is highly prevalent in the ICU. GABA-ergic anaesthetics may provoke
delirium. Alpha-2-adrenergic agonists may lead to a reduction of the total amount of
GABA-ergic anaesthetics and reduction of delirium. There are no large studies proving that
this therapy is effective and safe.
Objective: The objective of this study is to compare the effect of clonidine with placebo on
the occurrence and duration of delirium in mechanically ventilated ICU patients.
Study design: Prospective randomised double-blind placebo controlled intervention study in
115 patients.
Study population: All patients >18 years old, intubated mechanically ventilated and sedated
at inclusion.
Intervention: Clonidine infusion of 0,25 mcg/kg/h added to the standard sedation regimen.
Comparison: NaCl 0,9 % infusion as placebo.
Main study parameters/endpoints: The main study parameter is the total number of awake and
delirium-free observation periods the first 7 days after randomisation. An observation
period is a nursing shift of 8 hours.
Comparison of Epidural Fentanyl and Clonidine for Breakthrough Pain [Recruiting]
Epidural analgesia has proven to be an effective method for severe pain relief associated
with labor and delivery. During labor, a low dose continuous infusion of local anesthetic
and narcotic will be administered through an epidural catheter. As labor progresses and the
baby's head makes it way through the pelvis, breakthrough pain may emerge and often needs
further treatment. The investigators provide pain relief by administering analgesics through
the epidural catheter.
The patient will be randomly assigned to receive one of two medication mixtures believed to
be successful in treating this type of pain associated with advanced labor. After this
initial treatment, if pain relief is not attained, the patient may receive the other
medication as well. The medications used in this study have been used at this institution
for some time and have been found to be safe for mother and baby. The opioid (fentanyl) dose
is small and only a small fraction will be transmitted to the baby. The other medication
(clonidine) better known as a blood pressure medication has also been used for pain relief.
Studies and clinical experience have shown that clonidine when given epidurally in the doses
used in this study has minimal if any effect on the blood pressure of the mother or of the
baby. The investigators will record medical and obstetric history and labor progress
relevant to the patient. The patient will be asked questions regarding labor pain and side
effects before and after the analgesic is administered.
The primary objective is to determine which treatment regimen is more successful in
abolishing breakthrough pain in advanced labor.
Safety of Clonidine in Infants With Hypoxic Ischemic Encephalopathy During Therapeutic Hypothermia [Not yet recruiting]
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.
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