Published: August 01, 2011
AstraZeneca Announces U.S. Enrollment Opportunities for KODIAC Study to Investigate an Experimental Drug for Constipation from Opioids
WILMINGTON, Del. - (BUSINESS WIRE) - AstraZeneca
(NYSE:AZN)
today announced that study centers across the U.S. are recruiting
patients for a clinical
study to examine whether an investigational drug is safe and
effective in treating opioid-induced constipation (OIC). The study,
known as KODIAC, is a Phase III clinical trial examining an
investigational drug in patients experiencing constipation as a result
of opioid use, which is a potential side effect of prescription opioid
pain medications.
Opioids, such as morphine, are commonly prescribed to patients
experiencing chronic pain, which can provide relief from serious medical
conditions including osteoarthritis, cancer, and chronic back pain.1
In fact, opioids are considered the mainstay for cancer pain management,
with up to 70 percent of advanced cancer patients experiencing chronic
pain.1 However, pain medicines often may result in
debilitating side effects such as constipation.1 There are a
variety of strategies used to treat opioid-induced constipation;
however, many patients fail to find effective relief.1,2
"Up to 50 percent of patients on opioids can suffer from constipation,"
1 said Jaakko Lappalainen, M.D., Senior Director, Clinical
Research, AstraZeneca. "Patients taking opioids and experiencing
constipation are encouraged to consider speaking with their physicians
about their condition and ask about participation in a clinical trial.
The KODIAC study is a clinical trial being conducted to help determine
whether AstraZeneca's investigational drug may be helpful in treating
this medical problem."
Potential participants can learn more about the KODIAC study by watching
this short video
or visiting painandconstipation.com.
Information about the KODIAC study, including patient eligibility,
enrollment requirements, and study location sites can be obtained on the
Web site or by calling the patient hotline at 866-320-6956.
"AstraZeneca supports clinical
trial research examining new treatment approaches," said
Chris Fleischmann, R.N., Study Leader, AstraZeneca. "We encourage
sharing knowledge about clinical trials, like the KODIAC study, with
interested and eligible participants, as a means of furthering the
research community's efforts to find treatments for conditions like
opioid-induced constipation."
About Opioid-Induced Constipation
Patients taking opioids to treat chronic pain commonly experience a side
effect known as opioid-induced constipation, which may include
infrequent bowel movements and difficulty passing stools or emptying
bowels.1,2 Some studies have shown that up to 50 percent of
patients on opioids suffer from constipation.1 Current
treatment options may include laxatives, stool softeners, enemas, or
diet alterations, but these remedies are not always helpful and may
leave patients seeking additional relief methods.1,2
About the KODIAC Program
The KODIAC Program consists of two randomized, placebo controlled Phase
III efficacy studies and an open-label, randomized, placebo-controlled
long term safety study. The two efficacy studies are identical with
12-week treatment periods. These studies are intended to evaluate the
efficacy, safety and tolerability of an AstraZeneca investigational drug
in patients with OIC. KODIAC is part of the KODIAC program of studies
looking to determine whether this investigational drug is safe and
effective for the treatment of constipation seen as a side effect in
people taking prescription opioid pain medications. To learn more about
the KODIAC study, please visit painandconstipation.com.
About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business
with a primary focus on the discovery, development and commercialization
of prescription medicines for gastrointestinal, cardiovascular,
neuroscience, respiratory and inflammation, oncology and infectious
disease. AstraZeneca operates in over 100 countries and its innovative
medicines are used by millions of patients worldwide.
For more information about AstraZeneca in the U.S. or our AZ&Me
Prescription Savings programs, please visit: www.astrazeneca-us.com
or call 1-800-AZandMe (292-6363).
References
1 Reimer, K et al. Meeting the challenges of opioid-induced
constipation in chronic pain management - a novel approach. Pharmacology.
2009; 83:10-17.
2 Johanson, JF and Kraltein, J.
Chronic constipation: a survey of the patient perspective. Aliment
Pharmacol Ther. 2007; 25:599-608.
1340501 07/11
AstraZeneca
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Cell: 302-252-1586
or
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P: 302-885-3332
Cell:
215-760-2928
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