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Last Updated: November 18, 2019

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CLINICAL TRIALS PROFILE FOR ORPHENADRINE HYDROCHLORIDE

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All Clinical Trials for Orphenadrine Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01263652 Patient Preferences, Analgesic Delivery Method and Pain Reduction in Spine Patients Unknown status Western Galilee Hospital-Nahariya N/A 2010-12-01 The investigators will conduct a randomized double blind study, to determine whether patient analgesic delivery mode preference affects pain reduction quality in non-surgical spine patients. The patients will receive both intra-muscular and oral non-narcotic analgesics and placebo. During the study period, pain reduction parameters will be collected. At the end of the study period, the investigators will attempt to find a correlation between pre-study patient preferences and the quality of the pain reduction achieved.
NCT02423395 A Randomized Placebo Controlled Study of Orphenadrine` in the Treatment of Muscle Cramps in Patients With Cirrhosis Recruiting Tanta University Phase 3 2015-01-01 Muscle cramps are common in patients with liver disease and associated with significantly diminished quality of life. Patients with cirrhosis often experience muscle cramps with varied frequency and severity. The exact mechanisms by which they occur remain unclear, although a number of pathophysiological events unique to liver disease may contribute. Clinical studies have identified alterations in 3 areas: nerve function, energy metabolism, and plasma volume/electrolytes (1) Orphenadrine is an anticholinergic drug with prominent central nervous system (CNS) and peripheral actions used to treat painful muscle spasms and other similar conditions. The combination of anticholinergic effects and CNS penetration make orphenadrine useful for pain of all etiologies, including from: radiculopathy, muscles, and headaches. [3,4]
NCT02423395 A Randomized Placebo Controlled Study of Orphenadrine` in the Treatment of Muscle Cramps in Patients With Cirrhosis Recruiting Sherief Abd-Elsalam Phase 3 2015-01-01 Muscle cramps are common in patients with liver disease and associated with significantly diminished quality of life. Patients with cirrhosis often experience muscle cramps with varied frequency and severity. The exact mechanisms by which they occur remain unclear, although a number of pathophysiological events unique to liver disease may contribute. Clinical studies have identified alterations in 3 areas: nerve function, energy metabolism, and plasma volume/electrolytes (1) Orphenadrine is an anticholinergic drug with prominent central nervous system (CNS) and peripheral actions used to treat painful muscle spasms and other similar conditions. The combination of anticholinergic effects and CNS penetration make orphenadrine useful for pain of all etiologies, including from: radiculopathy, muscles, and headaches. [3,4]
NCT02449369 Intra-Venous Acetaminophen and Muscle Relaxants After Total Knee Recruiting Sagent Pharmaceuticals, Inc. Phase 4 2015-04-01 This is a prospective, three-arm, randomized, open-label trial to determine if a new pain control protocol which includes regular dosing of intravenous acetaminophen and orphenadrine for 48 hours after total knee surgery reduces the need for opioid pain medication and reduces average pain scores.
NCT02449369 Intra-Venous Acetaminophen and Muscle Relaxants After Total Knee Recruiting Florida Hospital Phase 4 2015-04-01 This is a prospective, three-arm, randomized, open-label trial to determine if a new pain control protocol which includes regular dosing of intravenous acetaminophen and orphenadrine for 48 hours after total knee surgery reduces the need for opioid pain medication and reduces average pain scores.
NCT02485145 The Analgesic Activity of a Topical Formulation in Patients With Osteoarthritis of the Hands Not yet recruiting Albert Einstein College of Medicine of Yeshiva University Phase 0 2015-07-01 Osteoarthritis (OA) affects over 30 million people in the United States and represents our nation's leading cause of disability. Data for the years between 1996-2005, indicate that OA raised overall health care costs by $185.5 billion annually. Largely as a consequence of this disease, the number of patients undergoing joint replacement surgery will quadruple over the next 17 years. Importantly, several recent studies have demonstrated that OA is an independent risk factor for cardiovascular disease . Presently investigators have no medications that alter the natural history of OA. Weight control, exercise and some physical therapy measures are the only interventions short of total joint replacement that alter the course of this disease. To make matters worse, investigators have experienced only setbacks in use of medications aimed at symptom control. Recognition of toxicities of non-steroidal anti-inflammatory drugs (NSAIDs) and narcotic-based analgesics has narrowed the presently available armamentarium for pain control in OA . Clearly OA is a major factor that demands better solutions as the health care system is redesigned. OA involving the hands represents a major part of the overall burden of this disease. In radiographic surveys about a quarter of the total US population has changes consistent with OA involving the hands. Among the elderly, radiographic hand OA has been found in over half of such individuals and as many as a quarter of them suffer from pain and functional incapacitation. The joints affected typically are the first carpometacarpal (CMC-1) joint, the distal interphalangeal (DIP) joints, and the proximal interphalangeal (PIP) joints . Therapeutic options include acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), and a variety of physical measures such as physical therapy, bracing, and heat and cold applications. To achieve some symptomatic benefit while limiting systemic toxicity, topical therapies have been developed which either act as counter irritants, seek to reduce substance P (capsaicin), or to deliver an NSAID locally through the skin. The leading example of the latter is Diclofenac sodium gel which was shown to reduce pain intensity and improve hand function in a double blind controlled trial. However none of these measures have proven sufficiently effective to meet patient needs. Topical polytherapy will be employed in this study to see if it will be effective against the pain of OA.
NCT02485145 The Analgesic Activity of a Topical Formulation in Patients With Osteoarthritis of the Hands Not yet recruiting Montefiore Medical Center Phase 0 2015-07-01 Osteoarthritis (OA) affects over 30 million people in the United States and represents our nation's leading cause of disability. Data for the years between 1996-2005, indicate that OA raised overall health care costs by $185.5 billion annually. Largely as a consequence of this disease, the number of patients undergoing joint replacement surgery will quadruple over the next 17 years. Importantly, several recent studies have demonstrated that OA is an independent risk factor for cardiovascular disease . Presently investigators have no medications that alter the natural history of OA. Weight control, exercise and some physical therapy measures are the only interventions short of total joint replacement that alter the course of this disease. To make matters worse, investigators have experienced only setbacks in use of medications aimed at symptom control. Recognition of toxicities of non-steroidal anti-inflammatory drugs (NSAIDs) and narcotic-based analgesics has narrowed the presently available armamentarium for pain control in OA . Clearly OA is a major factor that demands better solutions as the health care system is redesigned. OA involving the hands represents a major part of the overall burden of this disease. In radiographic surveys about a quarter of the total US population has changes consistent with OA involving the hands. Among the elderly, radiographic hand OA has been found in over half of such individuals and as many as a quarter of them suffer from pain and functional incapacitation. The joints affected typically are the first carpometacarpal (CMC-1) joint, the distal interphalangeal (DIP) joints, and the proximal interphalangeal (PIP) joints . Therapeutic options include acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), and a variety of physical measures such as physical therapy, bracing, and heat and cold applications. To achieve some symptomatic benefit while limiting systemic toxicity, topical therapies have been developed which either act as counter irritants, seek to reduce substance P (capsaicin), or to deliver an NSAID locally through the skin. The leading example of the latter is Diclofenac sodium gel which was shown to reduce pain intensity and improve hand function in a double blind controlled trial. However none of these measures have proven sufficiently effective to meet patient needs. Topical polytherapy will be employed in this study to see if it will be effective against the pain of OA.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Orphenadrine Hydrochloride

Condition Name

Condition Name for Orphenadrine Hydrochloride
Intervention Trials
Pain, Postoperative 2
Low Back Pain 1
Analgesic Adverse Reaction 1
Postural Low Back Pain 1
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Condition MeSH

Condition MeSH for Orphenadrine Hydrochloride
Intervention Trials
Low Back Pain 2
Back Pain 2
Pain, Postoperative 2
Spasm 1
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Clinical Trial Locations for Orphenadrine Hydrochloride

Trials by Country

Trials by Country for Orphenadrine Hydrochloride
Location Trials
Egypt 2
United States 2
Israel 1
Austria 1
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Trials by US State

Trials by US State for Orphenadrine Hydrochloride
Location Trials
New York 1
Florida 1
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Clinical Trial Progress for Orphenadrine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Orphenadrine Hydrochloride
Clinical Trial Phase Trials
Phase 4 4
Phase 3 2
Phase 0 1
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Clinical Trial Status

Clinical Trial Status for Orphenadrine Hydrochloride
Clinical Trial Phase Trials
Recruiting 5
Not yet recruiting 3
Unknown status 1
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Clinical Trial Sponsors for Orphenadrine Hydrochloride

Sponsor Name

Sponsor Name for Orphenadrine Hydrochloride
Sponsor Trials
Montefiore Medical Center 2
Sagent Pharmaceuticals, Inc. 1
Ache Laboratorios Farmaceuticos S.A. 1
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Sponsor Type

Sponsor Type for Orphenadrine Hydrochloride
Sponsor Trials
Other 10
Industry 3
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