Extension Study to Evaluate the Safety of Q8003 in Patients With Acute Moderate to Severe Pain
This is a Phase 3 double-blind, multiple dose safety extension study of Q8003 administered at daily doses up to 36 mg morphine/24 mg oxycodone (Q8003 36mg/24mg) over a treatment period of up to 4 weeks. Patients with acute moderate to severe pain who have completed participation in one of the designated QRxPharma, Inc. acute pain lead-in studies will be eligible for this trial.
The currently designated acute pain lead-in study is Study Q8003-007, which is a safety and efficacy study of Q8003 in the management of post-bunionectomy pain.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Acute Moderate to Severe Pain
Advanced Clinical Research Institute
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00565760
- Information obtained from ClinicalTrials.gov on July 15, 2010
This is a randomized, double-blind, multicenter, fixed dose factorial study of Q8003 12 mg/8 mg versus its individual morphine sulfate and oxycodone hydrochloride components for the manage...
This is a randomized, double-blind, multicenter, fixed dose factorial study of Q8003 12 mg/8 mg and Q8003 6 mg/4 mg versus its individual morphine sulfate and oxycodone hydrochloride compo...
The purpose of this study is to compare the analgesic efficacy and safety of tramadol HCl ER 100 mg, 200 mg and 300 mg once a day (QD), with placebo in patients with moderate to severe pai...
A Study Comparing the Effectiveness and Safety of Varying Dose Strengths (100, 200, 300 and 400 Mg) of Extended-Release Tramadol HCl With Placebo for the Treatment of Osteoarthritis(OA) of the Knee and/or Hip
The purpose of this study is to compare the effectiveness of multiple doses of once daily tramadol HCl ER (100, 200, 300 and 400 mg) to placebo in patients with moderate to severe pain due...
This is a Phase 3, two-arm, double-blind study of efficacy and safety of Q8003 in patients who have undergone primary unilateral total knee arthroplasty
Abstract Objective: To investigate the efficacy and safety of a bilayer combination oxycodone (OC) and acetaminophen (APAP) analgesic with both immediate-release and extended-release (ER) components (...
The standard opioids for relieving moderate to severe pain are: codeine as a step 2 analgesic and morphine for step 3. Tapentadol is an opioid similar to tramadol. An immediate-release form has been a...
To evaluate differences among physician specialties in the management of acute pain including prescribing practices and management of opioid-related side effects.
Delayed pain treatment is a common problem in emergency departments (EDs). The objective of this study was to examine the effect of age on time to ED patients receiving the first analgesic dose for mo...
While the validity of pain assessment has been well documented, the underlying schema (ie, organized, preconceived ideas) of how individuals interpret numerical pain ratings is not well understood. Th...
Medical and Biotech [MESH] Definitions
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.
An opioid analgesic with actions and uses similar to those of MORPHINE, apart from an absence of cough suppressant activity. It is used in the treatment of moderate to severe pain, including pain in obstetrics. It may also be used as an adjunct to anesthesia. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1092)
A clinical syndrome with acute abdominal pain that is severe, localized, and rapid onset. Acute abdomen may be caused by a variety of disorders, injuries, or diseases.
A narcotic antagonist with analgesic properties. It is used for the control of moderate to severe pain.
An opioid analgesic used similarly to MORPHINE in the control of moderate to severe pain. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1097)