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The primary objective for the 12-week Titration-/Maintenance Period is:
To demonstrate superior efficacy of OXN PR compared to PLA in the improvement of symptom severity of RLS.
A randomised, double-blind, placebo-controlled, parallel-group, multicenter study to demonstrate improvement of symptoms of RLS in subjects with moderate to severe idiopathic RLS with daytime symptoms who take oxycodone/naloxone prolonged release (OXN PR) compared to subjects taking placebo (PLA).
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Moderate to Severe Idiopathic RLS With Daytime Symptoms
Oxycodone naloxone prolonged release tablets (OXN PR), Placebo (PLA)
Paracelsus Elena Klinik
Mundipharma Research GmbH & Co KG
Published on BioPortfolio: 2014-08-27T03:14:06-0400
The primary objective of this study is to demonstrate that subjects with moderate to severe non-malignant pain taking oxycodone/naloxone prolonged release tablets have improvement in sympt...
The primary objective is to demonstrate that patients taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation compared to subjects taking oxycodone...
The primary objectives are - to demonstrate that the treatment with OXN PR tablets is non-inferior to the treatment with OxyPR with regards to analgesic efficacy and locomotor fun...
The purpose of this study is to compare oxycodone/naloxone combination tablet and codeine/paracetamol tablets in the treatment of moderate to severe chronic low back pain or pain due to os...
The primary objective of this trial is to study the efficacy of oxycodone/naloxone prolonged release tablets (OXN PR), compared to oxycodone prolonged release tablets (Oxy PR), for the red...
Opioid analgesics inhibit anal sphincter function and contribute to opioid-induced bowel dysfunction (OIBD). However, it is unknown whether the inhibition can be reduced by opioid antagonism with prol...
The purpose of this study was to determine whether oral prolonged- release oxycodone-naloxone combination (OXN) could provide equivalent analgesia and a side-effect profile similar to intravenous morp...
A randomized, double-blind, non-inferiority study of hydromorphone hydrochloride immediate-release tablets versus oxycodone hydrochloride immediate-release powder for cancer pain: efficacy and safety in Japanese cancer patients.
Hydromorphone is a standard opioid analgesic for cancer pain that, prior to this study, was not approved in Japan, where options for opioid switching are limited. We aimed to investigate the efficacy ...
Prescription opioid abuse continues to be a public health concern. Oxycodone ARIR is an immediate-release (IR) oxycodone tablet composed of multiple overlapping barriers that deter manipulation of the...
To characterize minocycline pharmacokinetics and relative bioavailability following multiple-dose topical administration of minocycline hydrochloride (HCl) foam 4% (FMX101 4%) as compared with single-...
Tablets coated with material that delays release of the medication until after they leave the stomach. (Dorland, 28th ed)
A narcotic analgesic that can be used for the relief of most types of moderate to severe pain, including postoperative pain and the pain of labor. Prolonged use may lead to dependence of the morphine type; withdrawal symptoms appear more rapidly than with morphine and are of shorter duration.
Severe systemic manifestation of trauma and ischemia involving soft tissues, principally skeletal muscle, due to prolonged severe crushing. It leads to increased permeability of the cell membrane and to the release of potassium, enzymes, and myoglobin from within cells. Ischemic renal dysfunction secondary to hypotension and diminished renal perfusion results in acute tubular necrosis and uremia.
A pharmaceutical preparation that combines buprenorphine, an OPIOID ANALGESIC with naloxone, a NARCOTIC ANTAGONIST to reduce the potential for NARCOTIC DEPENDENCE in the treatment of pain. It may also be used for OPIATE SUBSTITUTION THERAPY.
Derivative of noroxymorphone that is the N-cyclopropylmethyl congener of NALOXONE. It is a narcotic antagonist that is effective orally, longer lasting and more potent than naloxone, and has been proposed for the treatment of heroin addiction. The FDA has approved naltrexone for the treatment of alcohol dependence.
Of all the types of Dementia, Alzheimer's disease is the most common, affecting around 465,000 people in the UK. Neurons in the brain die, becuase 'plaques' and 'tangles' (mis-folded proteins) form in the brain. People with Al...