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Generated: February 22, 2019

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CLINICAL TRIALS PROFILE FOR PROPOXYPHENE HYDROCHLORIDE 65

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Clinical Trials for Propoxyphene Hydrochloride 65

Trial ID Title Status Sponsor Phase Summary
NCT00240786 An Effectiveness and Safety Study of Two Doses of Acetaminophen Extended Release Caplets in the Treatment of Osteoarthritis of the Hip or Knee Completed Johnson & Johnson Consumer and Personal Products Worldwide Phase 3 The purpose of this study is to determine the safety and effectiveness of 650 mg and 1300 mg acetaminophen extended release given three times a day for the relief of signs and symptoms of osteoarthritis of the hip or knee for a period of 12 weeks.
NCT00240799 An Effectiveness and Safety Study of Acetaminophen Extended Release Caplets in the Treatment of Osteoarthritis of the Hip or Knee. Completed McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. Phase 3 The purpose of this study is to evaluate acetaminophen extended release (3900 mg/day) compared to placebo for safety and effectiveness in the relief of signs and symptoms of osteoarthritis of the hip or knee over 12 weeks
NCT00240799 An Effectiveness and Safety Study of Acetaminophen Extended Release Caplets in the Treatment of Osteoarthritis of the Hip or Knee. Completed Johnson & Johnson Consumer and Personal Products Worldwide Phase 3 The purpose of this study is to evaluate acetaminophen extended release (3900 mg/day) compared to placebo for safety and effectiveness in the relief of signs and symptoms of osteoarthritis of the hip or knee over 12 weeks
NCT00317447 The Efficacy of Oral Steroids in the Treatment of Acute Sciatica Completed Kaiser Permanente Phase 3 Sciatica (lumbosacral radiculopathy) is a common diagnosis in primary care, occurring in approximately one percent of all patients with acute low back pain. (1, 2) Traditional treatment generally involves pain control (acetominophen, NSAID’s, or narcotics), activity as tolerated, and time. (1, 3-8 ) The general consensus is that fifty percent of patients with sciatica recover within six weeks, and that ninety percent are better in twelve weeks.(4, 8) Those patients with intractable pain or progressive neurologic symptoms usually receive epidural steroid injections and, if necessary, decompressive laminectomy or discectomy. (2, 8, 9) Low back pain and sciatica result in tremendous losses to our society in terms of decreased productivity and cost of treatment. (1, 12) Oral steroids are inexpensive and relatively safe medications that, if effective in reducing the pain and disability associated with sciatica, could improve the quality of patients’ lives, and result in significant cost savings to society at large. We hypothesize that the use of oral steroids to treat acute sciatica will speed patients’ recovery as measured by: changes in physical findings, rates of return to work and activities of daily living, pain and disability assessment scores, and decreases in the use of narcotic and non-steroidal anti-inflammatory drugs (NSAID’s), and in the need for epidural injection or surgical intervention.
NCT00640159 Tolerability and Efficacy of Switch From Oral Selegiline to Orally Disintegrating Selegiline (Zelapar) in Patients With Parkinson's Disease Completed Baylor College of Medicine Phase 4 Parkinson's disease (PD) is a progressive neurodegenerative disease. Symptomatic therapy is primarily aimed at restoring dopamine function in the brain. Oral selegiline in conjunction with L-dopa has been a mainstay of therapy for PD patients experiencing motor fluctuations for many years. The mechanisms accounting for selegiline's beneficial adjunctive action in the treatment of PD are not fully understood. Inhibition of monoamine oxidase (MAO) type B (MAO-B) activity is generally considered to be of primary importance. Oral selegiline has low bio-availability and is typically dosed BID, for a total of 5-10 mg daily. Recently, the FDA approved a new orally disintegration tablet (ODT) formulation of selegiline, called ZelaparTM. This new formulation utilizes Zydis technology to dissolve in the mouth, with absorption through the oral mucosa, thereby largely bypassing the gut and avoiding first pass hepatic metabolism. This allows more active drug to be delivered at a lower dose. Consequently, Zelapar is dosed once-daily, up to 2.5 mg per day. There are no empirical data indicating whether the use of the new approved formulation of selegiline ODT (Zelapar) is superior or preferred by patients compared to traditional oral selegiline. It is believed that clinical efficacy will be preserved or enhanced, by delivering more active drug, with improved patient preference for the ODT formulation due to the once-daily dosing . The effectiveness of orally disintegrating selegiline as an adjunct to carbidopa/levodopa in the treatment of PD was established in a multicenter randomized placebo-controlled trial (n=140; 94 received orally disintegrating selegiline, 46 received placebo) of three months' duration. Patients randomized to orally disintegrating selegiline received a daily dose of 1.25 mg for the first 6 weeks and a daily dose of 2.5 mg for the last 6 weeks. Patients were all treated with levodopa and could additionally have been on dopamine agonists, anticholinergics, amantadine, or any combination of these during the trial. At 12 weeks, orally disintegrating selegiline-treated patients had an average of 2.2 hours per day less "OFF" time compared to baseline. Placebo treated patients had 0.6 hours per day less "OFF" time compared to baseline. These differences were significant (p < 0.001). Adverse events were very similar between drug and placebo.
NCT00652093 Lumbar Stenosis Outcomes Research II Terminated Endo Pharmaceuticals Phase 4 The primary objective of the proposed pilot study is to determine the efficacy of oxymorphone hydrochloride and propoxyphene/acetaminophen combination in prolonging the time to onset of pain and reducing the severity of pain associated with walking in patients lumbar spinal stenosis that have clinical symptoms of neurogenic claudication. Neurogenic claudication is defined as movement induced leg pain, numbness, heaviness, or vague discomfort in part or all of one or both legs provoked with walking and standing and relieved by sitting, squatting, or forward flexion posturing. The secondary objective is to examine the functional benefit of oxymorphone hydrochloride and propoxyphene/acetaminophen combination with respect to improvement in duration and distance of walking.
NCT00652093 Lumbar Stenosis Outcomes Research II Terminated University of Rochester Phase 4 The primary objective of the proposed pilot study is to determine the efficacy of oxymorphone hydrochloride and propoxyphene/acetaminophen combination in prolonging the time to onset of pain and reducing the severity of pain associated with walking in patients lumbar spinal stenosis that have clinical symptoms of neurogenic claudication. Neurogenic claudication is defined as movement induced leg pain, numbness, heaviness, or vague discomfort in part or all of one or both legs provoked with walking and standing and relieved by sitting, squatting, or forward flexion posturing. The secondary objective is to examine the functional benefit of oxymorphone hydrochloride and propoxyphene/acetaminophen combination with respect to improvement in duration and distance of walking.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Propoxyphene Hydrochloride 65

Condition Name

Condition Name for Propoxyphene Hydrochloride 65
Intervention Trials
Osteoarthritis 2
Atrial Fibrillation 1
Parkinson's Disease 1
Obesity 1
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Condition MeSH

Condition MeSH for Propoxyphene Hydrochloride 65
Intervention Trials
Osteoarthritis, Hip 2
Osteoarthritis 2
Atrial Fibrillation 1
Spinal Stenosis 1
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Clinical Trial Locations for Propoxyphene Hydrochloride 65

Trials by Country

Trials by Country for Propoxyphene Hydrochloride 65
Location Trials
United States 6
Egypt 1
Brazil 1
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Trials by US State

Trials by US State for Propoxyphene Hydrochloride 65
Location Trials
California 2
Utah 1
New York 1
Texas 1
Florida 1
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Clinical Trial Progress for Propoxyphene Hydrochloride 65

Clinical Trial Phase

Clinical Trial Phase for Propoxyphene Hydrochloride 65
Clinical Trial Phase Trials
Phase 4 4
Phase 3 3
Phase 1/Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Propoxyphene Hydrochloride 65
Clinical Trial Phase Trials
Completed 5
Terminated 2
Recruiting 1
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Clinical Trial Sponsors for Propoxyphene Hydrochloride 65

Sponsor Name

Sponsor Name for Propoxyphene Hydrochloride 65
Sponsor Trials
Johnson & Johnson Consumer and Personal Products Worldwide 2
Xanodyne Pharmaceuticals 1
University of Rochester 1
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Sponsor Type

Sponsor Type for Propoxyphene Hydrochloride 65
Sponsor Trials
Other 6
Industry 5
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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Argus Health
Daiichi Sankyo
Moodys
AstraZeneca
Express Scripts
Teva
QuintilesIMS
Johnson and Johnson

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