DURACLON clinical studies: Difference between revisions
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==Clinical Studies== | ==Clinical Studies== | ||
==Clinical Trials== | |||
In a double-blind, randomized study of cancer patients with severe intractable pain below the C4 dermatome not controlled by [[morphine]], 38 patients were randomized to an epidural infusion of Duraclon plus epidural morphine, whereas 47 subjects received epidural placebo plus epidural morphine. Both groups were allowed rescue doses of epidural morphine. Successful analgesia, defined as a decrease in either morphine use or Visual Analog Score (VAS) pain, was significantly more common with epidural clonidine than placebo (45% vs 21%, p=0.016). Only the subgroup of 36 patients with ‘‘[[neuropathic]]’’ pain, characterized by the investigator as well-localized, burning, shooting, or electric-like pain in a dermatomal or peripheral nerve distribution had significant analgesic effects relative to placebo in this study. | |||
The most frequent adverse events with clonidine were [[hypotension]] (45% vs 11% for placebo, p< 0.001), postural [[hypotension]] (32% vs 0%, p< 0.001), [[dizziness]] (13% vs 4%, p=0.234), anxiety (11% vs 2%, p=0.168) and dry mouth (13% vs 9%, p=0.505). Both mean blood pressure and heart rate were reduced in the clonidine group. At the conclusion of the two week study period in the clinical trial, all patients were abruptly withdrawn from study drug or placebo. Four patients of the clonidine group suffered rebound hypertension upon withdrawal of clonidine; one of these patients suffered a cerebrovascular accident. Asymptomatic [[bradycardia]] was noted in one clonidine patient.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = DURACLON (CLONIDINE HYDROCHLORIDE) INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8c126bb8-732a-4949-8754-2f50b5543638#i4i_clinical_pharmacology_id_a61d4026-7aae-4211-9bb5-332675db4e46 | publisher = | date = | accessdate = 6 February 2014 }}</ref> | |||
==References== | ==References== | ||
Latest revision as of 16:49, 6 February 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Pratik Bahekar, MBBS [2]
For patient information, click here.
Clinical Studies
Clinical Trials
In a double-blind, randomized study of cancer patients with severe intractable pain below the C4 dermatome not controlled by morphine, 38 patients were randomized to an epidural infusion of Duraclon plus epidural morphine, whereas 47 subjects received epidural placebo plus epidural morphine. Both groups were allowed rescue doses of epidural morphine. Successful analgesia, defined as a decrease in either morphine use or Visual Analog Score (VAS) pain, was significantly more common with epidural clonidine than placebo (45% vs 21%, p=0.016). Only the subgroup of 36 patients with ‘‘neuropathic’’ pain, characterized by the investigator as well-localized, burning, shooting, or electric-like pain in a dermatomal or peripheral nerve distribution had significant analgesic effects relative to placebo in this study.
The most frequent adverse events with clonidine were hypotension (45% vs 11% for placebo, p< 0.001), postural hypotension (32% vs 0%, p< 0.001), dizziness (13% vs 4%, p=0.234), anxiety (11% vs 2%, p=0.168) and dry mouth (13% vs 9%, p=0.505). Both mean blood pressure and heart rate were reduced in the clonidine group. At the conclusion of the two week study period in the clinical trial, all patients were abruptly withdrawn from study drug or placebo. Four patients of the clonidine group suffered rebound hypertension upon withdrawal of clonidine; one of these patients suffered a cerebrovascular accident. Asymptomatic bradycardia was noted in one clonidine patient.[1]
References
- ↑ "DURACLON (CLONIDINE HYDROCHLORIDE) INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]". Retrieved 6 February 2014.