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Last Updated: July 8, 2020

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CLINICAL TRIALS PROFILE FOR MEPERIDINE HYDROCHLORIDE

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505(b)(2) Clinical Trials for Meperidine Hydrochloride

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 Meperidine Hydrochloride

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.
NCT00286052 Impact of Low Dose Naloxone on Fentanyl Requirements in Pediatric ICU Patients Completed University of Texas Southwestern Medical Center Phase 3 2002-12-01 Recently there has been an increased awareness in the need for adequate sedation and pain control for Pediatric Intensive Care Unit (ICU) patients. Fentanyl is an opioid commonly used in Pediatric ICU patients to decrease pain and increase sedation. Although opioids (e.g. morphine and fentanyl) provide excellent pain relief, they have many side effects including dependence, tolerance and withdrawal. These side effects lead to increased doses in order to maintain pain control and/or sedation. There have been a few adult studies pointing to some possible treatments. For example, giving low dose naloxone along with opioids. Adult studies show that this combination not only decreases the frequency of opioid side effects, but also improves pain control and prevents the development of tolerance. We propose that children who receive low dose naloxone infusions along with fentanyl infusions will demonstrate: 1) decreased total daily doses of Fentanyl, 2) decreased frequency of withdrawal and 3) increased pain and sedation control. In this randomized, blinded prospective trial we will enroll 168 Pediatric ICU patients. Patients will receive either low dose naloxone or placebo simultaneously with their fentanyl infusion. Pain and sedation will be assessed using the Modified Motor Activity Assessment Scale (MMAAS). The fentanyl infusion will be increased to provide adequate pain control and/or sedation. Naloxone infusion will not be adjusted. Approximately 48 hours prior to removal from the ventilator, patients will have their fentanyl infusions decreased while being monitored for withdrawal. Patients showing signs of withdrawal will receive methadone, an opioid taken by mouth. Once off fentanyl, naloxone will be stopped. Patients will continue to be monitored for withdrawal for 4 days or until ICU discharge. If this study works, patients who receive low dose naloxone along with opioid infusions will have less tolerance and dependence and demonstrate less withdrawal. This may cause shorter Intensive Care Unit stays.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Meperidine Hydrochloride

Condition Name

Condition Name for Meperidine Hydrochloride
Intervention Trials
Pain 5
Labor Pain 4
Abnormal Uterine Bleeding Unrelated to Menstrual Cycle 2
Pancreatitis 2
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Condition MeSH

Condition MeSH for Meperidine Hydrochloride
Intervention Trials
Labor Pain 4
Gallbladder Diseases 3
Leukemia 2
Graft vs Host Disease 2
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Clinical Trial Locations for Meperidine Hydrochloride

Trials by Country

Trials by Country for Meperidine Hydrochloride
Location Trials
United States 23
Egypt 8
Canada 6
Korea, Republic of 5
Thailand 4
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Trials by US State

Trials by US State for Meperidine Hydrochloride
Location Trials
Texas 6
California 2
New York 2
Washington 1
Ohio 1
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Clinical Trial Progress for Meperidine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Meperidine Hydrochloride
Clinical Trial Phase Trials
Phase 4 24
Phase 3 4
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Meperidine Hydrochloride
Clinical Trial Phase Trials
Completed 26
Recruiting 11
Unknown status 10
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Clinical Trial Sponsors for Meperidine Hydrochloride

Sponsor Name

Sponsor Name for Meperidine Hydrochloride
Sponsor Trials
University of Texas Southwestern Medical Center 3
University of Alberta 2
Mansoura University 2
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Sponsor Type

Sponsor Type for Meperidine Hydrochloride
Sponsor Trials
Other 81
Industry 4
NIH 1
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Serving leading biopharmaceutical companies globally:

Mallinckrodt
McKesson
Harvard Business School
Express Scripts
Baxter
Merck

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