Extension Study to Evaluate the Safety of Q8003 in Patients With Acute Moderate to Severe Pain
Summary
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.
Description
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.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Conditions
Acute Moderate to Severe Pain
Intervention
Q8003, Placebo
Location
Advanced Clinical Research Institute
Anaheim
California
United States
92801
Status
Completed
Source
QRxPharma Inc.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00565760
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Meperidine
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.
Oxymorphone
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)
Abdomen, Acute
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.
Meptazinol
A narcotic antagonist with analgesic properties. It is used for the control of moderate to severe pain.
Tilidine
An opioid analgesic used similarly to MORPHINE in the control of moderate to severe pain. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1097)
Clinical Trials
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PubMed Articles
Tapentadol immediate release: a review of its use in the treatment of moderate to severe acute pain.
Tapentadol (Nucynta) is an orally active, centrally acting synthetic analgesic that is thought to exert its analgesic effects via two mechanisms of action (mu-opioid receptor agonism and norepinephrin...
Treating acute pain in the hospitalized patient.
ABSTRACT: Many hospitalized patients report moderate-to-severe pain despite the use of epidural or patient-controlled analgesia. This article will explore the use of multimodal options for analgesia i...
Acute effects of dietary ginger on muscle pain induced by eccentric exercise.
Zingiber officinale, commonly known as ginger, has analgesic and antiinflammatory properties. The acute effects of ginger on muscle pain, inflammation and dysfunction induced by eccentric exercise wer...
No effect of acute L-arginine supplementation on O(2) cost or exercise tolerance.
The extent to which dietary supplementation with the nitric oxide synthase (NOS) substrate, L-arginine (ARG), impacts on NO production and NO-mediated physiological responses is controversial. This ra...
Low back pain affects about 70% of people in resource-rich countries at some point in their lives. Acute low back pain can be self-limiting; however, 1 year after an initial episode, as many as 33% of...
