CLINICAL TRIALS PROFILE FOR ULTRAM ER
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505(b)(2) Clinical Trials for Ultram Er
| 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 | >Sponsor | >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. |
| 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. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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