Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 14, 2019

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CLINICAL TRIALS PROFILE FOR DEMEROL

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505(b)(2) Clinical Trials for Demerol

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation 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 2007-01-01 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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Demerol

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00154895 Additional Minocycline Pleurodesis After Thoracoscopic Procedures for Primary Spontaneous Pneumothorax Unknown status National Science Council, Taiwan Phase 3 2001-06-01 To test if additional minocycline pleurodesis after thoracoscopic procedures can reduce the rates of ipsilateral recurrence for patients with primary spontaneous pneumothorax.
NCT00154895 Additional Minocycline Pleurodesis After Thoracoscopic Procedures for Primary Spontaneous Pneumothorax Unknown status National Taiwan University Hospital Phase 3 2001-06-01 To test if additional minocycline pleurodesis after thoracoscopic procedures can reduce the rates of ipsilateral recurrence for patients with primary spontaneous pneumothorax.
NCT00240123 Effect of Benadryl Sedation During ERCP or EUS Withdrawn University of Rochester Phase 1 2005-07-01 The purpose of the study is to determine if adding Benadryl improves sedation for patients scheduled to undergo ERCP or EUS procedures.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Demerol

Condition Name

Condition Name for Demerol
Intervention Trials
Gallstones 1
Pain 1
Gallbladder Disease 1
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Condition MeSH

Condition MeSH for Demerol
Intervention Trials
Anemia, Sickle Cell 1
Pancreatitis 1
Anemia 1
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Clinical Trial Locations for Demerol

Trials by Country

Trials by Country for Demerol
Location Trials
United States 14
Canada 2
Taiwan 1
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Trials by US State

Trials by US State for Demerol
Location Trials
Texas 3
Ohio 1
North Carolina 1
New York 1
Illinois 1
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Clinical Trial Progress for Demerol

Clinical Trial Phase

Clinical Trial Phase for Demerol
Clinical Trial Phase Trials
Phase 4 2
Phase 3 2
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Demerol
Clinical Trial Phase Trials
Unknown status 3
Completed 3
Recruiting 3
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Clinical Trial Sponsors for Demerol

Sponsor Name

Sponsor Name for Demerol
Sponsor Trials
University of Alabama at Birmingham 1
Monica Bhatia 1
Pfizer 1
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Sponsor Type

Sponsor Type for Demerol
Sponsor Trials
Other 11
Industry 1
U.S. Fed 1
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