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Last Updated: May 21, 2022

CLINICAL TRIALS PROFILE FOR ULTRAM ER


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505(b)(2) Clinical Trials for Ultram Er

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
OTC NCT04694300 ↗ OTC Naproxen and Acetaminophen Anti-Inflammatory Action in Dental Implant Patients Recruiting Bayer Phase 4 2021-02-07 This double-blind pilot study will evaluate the anti-inflammatory and analgesic effects of an over-the-counter (OTC) regimen of naproxen sodium versus acetaminophen in patients receiving one or two (adjacent) dental implants. It will also confirm that naproxen sodium in the OTC dosage range is a good alternative to immediate-release opioid formulations, which are subject to misuse, abuse and diversion in this patient population.
OTC NCT04694300 ↗ OTC Naproxen and Acetaminophen Anti-Inflammatory Action in Dental Implant Patients Recruiting University of Pennsylvania Phase 4 2021-02-07 This double-blind pilot study will evaluate the anti-inflammatory and analgesic effects of an over-the-counter (OTC) regimen of naproxen sodium versus acetaminophen in patients receiving one or two (adjacent) dental implants. It will also confirm that naproxen sodium in the OTC dosage range is a good alternative to immediate-release opioid formulations, which are subject to misuse, abuse and diversion in this patient population.
OTC NCT04694300 ↗ OTC Naproxen and Acetaminophen Anti-Inflammatory Action in Dental Implant Patients Recruiting Hersh, Elliot V., DMD, MS, PhD Phase 4 2021-02-07 This double-blind pilot study will evaluate the anti-inflammatory and analgesic effects of an over-the-counter (OTC) regimen of naproxen sodium versus acetaminophen in patients receiving one or two (adjacent) dental implants. It will also confirm that naproxen sodium in the OTC dosage range is a good alternative to immediate-release opioid formulations, which are subject to misuse, abuse and diversion in this patient population.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Ultram Er

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00236483 ↗ A Comparison of the Effectiveness and Safety of ULTRACET® (Tramadol Hydrochloride/Acetaminophen) Versus ULTRAM® (Tramadol Hydrochloride) Versus Placebo in Patients With Pain After Oral Surgery Completed PriCara, Unit of Ortho-McNeil, Inc. Phase 4 2002-11-01 The purpose of this study is to explore the pain-relieving effects and safety of two analgesic treatment regimens as compared to placebo in patients experiencing pain after oral surgery. Tramadol hydrochloride/acetaminophen is approved to treat acute pain. This study will evaluate the effectiveness and safety of tramadol hydrochloride/acetaminophen compared with tramadol hydrochloride alone compared with placebo as a pain medication in the treatment of pain following oral surgery.
NCT00236483 ↗ A Comparison of the Effectiveness and Safety of ULTRACET® (Tramadol Hydrochloride/Acetaminophen) Versus ULTRAM® (Tramadol Hydrochloride) Versus Placebo in Patients With Pain After Oral Surgery Completed Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Phase 4 2002-11-01 The purpose of this study is to explore the pain-relieving effects and safety of two analgesic treatment regimens as compared to placebo in patients experiencing pain after oral surgery. Tramadol hydrochloride/acetaminophen is approved to treat acute pain. This study will evaluate the effectiveness and safety of tramadol hydrochloride/acetaminophen compared with tramadol hydrochloride alone compared with placebo as a pain medication in the treatment of pain following oral surgery.
NCT00290901 ↗ Celebrex vs Tramadol in the Treatment of Chronic Lower Back Pain. Completed Pfizer Phase 4 2006-03-01 This study investigates if Celebrex is as effective as tramadol hydrochloride (Ultram) for patients with chronic low back pain, when administered over a 6-week period.
NCT00290901 ↗ Celebrex vs Tramadol in the Treatment of Chronic Lower Back Pain. Completed Pfizer's Upjohn has merged with Mylan to form Viatris Inc. Phase 4 2006-03-01 This study investigates if Celebrex is as effective as tramadol hydrochloride (Ultram) for patients with chronic low back pain, when administered over a 6-week period.
NCT00301210 ↗ Assessment of Tramadol as a Treatment for Opioid Addiction Completed National Institute on Drug Abuse (NIDA) Phase 1/Phase 2 2006-01-01 Opioids are one of the most commonly abused drugs among individuals who seek treatment for drug abuse. Thus, it is necessary to develop new treatments for opioid addiction. The purpose of this trial is determine whether tramadol is effective in treating opioid dependent individuals.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Ultram Er

Condition Name

Condition Name for Ultram Er
Intervention Trials
Pain 6
Opioid Addiction 2
Healthy 2
Pain, Postoperative 2
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Condition MeSH

Condition MeSH for Ultram Er
Intervention Trials
Opioid-Related Disorders 3
Pain, Postoperative 2
Neoplasms 1
Back Pain 1
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Clinical Trial Locations for Ultram Er

Trials by Country

Trials by Country for Ultram Er
Location Trials
United States 36
Puerto Rico 1
Denmark 1
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Trials by US State

Trials by US State for Ultram Er
Location Trials
Maryland 4
Illinois 3
Utah 2
Minnesota 2
Pennsylvania 2
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Clinical Trial Progress for Ultram Er

Clinical Trial Phase

Clinical Trial Phase for Ultram Er
Clinical Trial Phase Trials
Phase 4 9
Phase 3 1
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Ultram Er
Clinical Trial Phase Trials
Completed 13
Recruiting 3
Unknown status 2
[disabled in preview] 2
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Clinical Trial Sponsors for Ultram Er

Sponsor Name

Sponsor Name for Ultram Er
Sponsor Trials
National Institute on Drug Abuse (NIDA) 4
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. 3
Children's Hospitals and Clinics of Minnesota 2
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Sponsor Type

Sponsor Type for Ultram Er
Sponsor Trials
Other 15
Industry 13
NIH 4
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