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. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for ULTRAM ER
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Clinical Trial Locations for ULTRAM ER
Trials by Country
Clinical Trial Progress for ULTRAM ER
Clinical Trial Phase
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 |
| [disabled in preview] | 2 |
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