Track topics on Twitter Track topics that are important to you
The objective of the study is to investigate the effectiveness, safety of JNS024ER (now known as and referred to throughout this posting as Tapentadol ER) at doses 25-250 mg twice daily, and to explore the pharmacokinetics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) in Japanese patients with moderate to severe chronic pain due to painful diabetic peripheral neuropathy or postherpetic neuralgia.
This is a randomized (study drug assigned, multicenter, double-blind (neither physician nor patient knows the name of the assigned drug), placebo-controlled (patients are randomly assigned to a test treatment or to an identical-appearing treatment that does not contain the test drug) parallel-group comparison study in the patients with chronic pain due to painful diabetic peripheral neuropathy or postherpetic neuralgia. The study will be explained and informed consent will be obtained. Patients will be screened for study eligibility at Visit 1. The study will be explained and informed consent will be obtained. Patients will be screened for study eligibility at Visit 1. Potential patients must satisfy all eligibility criteria to be enrolled in the study. Eligible candidates will proceed to the study treatment period. At the time of study entry, all prohibited medications will be discontinued and will be disallowed throughout the study. The study consists of 3 periods: a 1-week screening period during which patients are evaluated for study eligibility; a 12-week study treatment period (maximum of 6-week dose adjustment phase and minimum of 6-week of dose maintenance phase); and a one-week follow-up period. The sponsor will collect adverse events starting with the signing of the informed consent form until completion of the last study-related procedure (may include contact for follow-up of safety). Adverse events include any occurrence that is new in onset or get worse in severity or frequency from the baseline condition, or abnormal results of diagnostic procedures, including laboratory test abnormalities. Blood samples for serum chemistry and hematology, a urine sample for urinalysis, vital signs, 12-lead electrocardiography and Clinical opioid withdrawal symptoms questionnaire will be also collected for safety evaluation. Numerical Rating Scale, Sleep questionnaire, Brief Pain Inventory Short Form, Short Form 36 Health Survey, Patient's global impression of change and Physician's global assessment will be collected for efficacy evaluation. Serum drug concentrations will also collected for pharmacokinetics evaluation. Patients will be randomized to one of the two following treatment groups: Tapentadol ER group and Placebo group. Tapentadol ER or placebo will be administered orally twice daily in the morning and evening. The dose ranges is between 50 and 500 mg/day. The maximum dose is 250 mg/intake (500 mg/day). The investigator determine based on consultation at patient visits and the patient diary whether or not the dose may be increased. Tapentadol ER or placebo will be administered orally twice daily in the morning and evening. The dose range is between 50 and 500 mg/day. The maximum dose is 250 mg/intake (500 mg/day). The 12-week treatment period consists of two phases: maximum of 6-week dose adjustment phase and minimum of 6-week dose maintenance phase.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Tapentadol ER, Placebo
Janssen Pharmaceutical K.K.
Published on BioPortfolio: 2014-07-24T14:05:43-0400
The purpose of this study is to determine the effectiveness and safety of tapentadol immediate release (IR) as compared with placebo and oxycodone IR in patients with acute pain caused by ...
The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of tapentadol PR in patients with moderate to severe cancer pain
The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of 2 different dose levels of tapentadol (CG5503) compared with oxycodon...
A Randomized, Double-Blind, Parallel-Arm, Placebo and Active Controlled Dose-Ranging Study of the Efficacy and Safety of Multiple Doses of Tapentadol IR for Postoperative Pain Following Bunionectomy Surgery
This study was to evaluate the efficacy and safety of dosing regimens of tapentadol HCl immediate release capsules for the treatment of postoperative pain over a period of 12 hours on the ...
The purpose of this trial is to evaluate the effectiveness (level of pain control) and safety of orally administered tapentadol (CG5503) Extended Release (ER) (base) at doses of 100-250 mg...
Cancer-related neuropathic pain is sometimes unresponsive to multidrug treatment. Novel drugs are required to treat such severe pain without necessitating the use of adjuvant analgesics. Tapentadol is...
OBJECTIVE To evaluate pharmacokinetic and pharmacodynamic characteristics of 3 doses of tapentadol hydrochloride orally administered in dogs. ANIMALS 6 healthy adult mixed-breed dogs. PROCEDURES In a ...
Higher levels of fear have been shown to partly explain individual differences in placebo analgesic responding. The COMT rs4680 Val158Met polymorphism has been associated with both increased placebo a...
Although placebo analgesia is a well-recognized phenomenon with important clinical implications, the possibility that placebo effects occur during sleep has received little attention. This experimenta...
There is a clinical need for potent opioids that produce little or no respiratory depression. In the current study we compared the respiratory effects of tapentadol, a mu-opioid receptor agonist and n...
A type of pain that is perceived in an area away from the site where the pain arises, such as facial pain caused by lesion of the VAGUS NERVE, or throat problem generating referred pain in the ear.
Pain in the facial region including orofacial pain and craniofacial pain. Associated conditions include local inflammatory and neoplastic disorders and neuralgic syndromes involving the trigeminal, facial, and glossopharyngeal nerves. Conditions which feature recurrent or persistent facial pain as the primary manifestation of disease are referred to as FACIAL PAIN SYNDROMES.
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
Dull or sharp aching pain caused by stimulated NOCICEPTORS due to tissue injury, inflammation or diseases. It can be divided into somatic or tissue pain and VISCERAL PAIN.
Acute pain that comes on rapidly despite the use of pain medication.
Pain is defined by the International Association for the Study of Pain as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage”. Some illnesses can be excruci...
Diabetes is a lifelong condition that causes a person's blood sugar level to become too high. The two main types of diabetes are: type 1 diabetes type 2 diabetes In the UK, diabetes affects approximately 2.9 million people. There are a...
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...