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Last Updated: September 21, 2021

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CLINICAL TRIALS PROFILE FOR ULTRAM

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505(b)(2) Clinical Trials for Ultram

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 Not yet recruiting Bayer Phase 4 2021-01-20 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 Not yet recruiting University of Pennsylvania Phase 4 2021-01-20 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 Not yet recruiting Hersh, Elliot V., DMD, MS, PhD Phase 4 2021-01-20 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

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.
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.
NCT00301210 ↗ Assessment of Tramadol as a Treatment for Opioid Addiction Completed Johns Hopkins University 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.
NCT00499746 ↗ The Discriminative Effects of Tramadol in Humans Completed National Institute on Drug Abuse (NIDA) Phase 1/Phase 2 2007-11-01 This research is part of a set of studies whose purpose is to test whether tramadol can be used for the treatment of opioid addiction. Tramadol is already available in the United States as a pain medicine marketed as Ultram. It has effects similar to morphine, and it may also have effects similar to other drugs like stimulants. The doses of tramadol used in this study are higher than those generally used for the treatment of pain. To be in this study a participant must be a user of opioids (drugs like heroin) and stimulants (drugs like cocaine), but cannot be addicted to either. The person must be between 21-55 years old, and generally healthy. Up to 12 people will take part in this study.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Ultram

Condition Name

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

Condition MeSH for Ultram
Intervention Trials
Opioid-Related Disorders 2
Pain, Postoperative 2
Head and Neck Neoplasms 1
Tonsillitis 1
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Clinical Trial Locations for Ultram

Trials by Country

Trials by Country for Ultram
Location Trials
United States 35
Denmark 1
Puerto Rico 1
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Trials by US State

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

Clinical Trial Phase

Clinical Trial Phase for Ultram
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
Clinical Trial Phase Trials
Completed 11
Not yet recruiting 5
Recruiting 2
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Clinical Trial Sponsors for Ultram

Sponsor Name

Sponsor Name for Ultram
Sponsor Trials
National Institute on Drug Abuse (NIDA) 4
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. 3
Johns Hopkins University 2
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Sponsor Type

Sponsor Type for Ultram
Sponsor Trials
Other 14
Industry 12
NIH 4
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