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Last Updated: November 18, 2019

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CLINICAL TRIALS PROFILE FOR ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

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505(b)(2) Clinical Trials for Acetaminophen; Tramadol 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
OTC NCT01588158 Patient Satisfaction With Pain Relief After Ambulatory Hand Surgery Terminated Massachusetts General Hospital Phase 4 2012-07-01 Adequate pain relief has been a priority of the Joint Commission and is featured on national inpatient surveys such as the H-CAHPS. When considering methods for improving satisfaction with pain relief in the United States, a great deal of emphasis has been placed on opioid pain medications. Some of this emphasis on opioid pain medication is driven by the pharmaceutical industry and by advocacy groups with ties to the pharmaceutical industry. There is evidence that the "pain is the fifth vital sign" campaign of the Joint Commission led to an increased incidence of prescription of opioids, but there is less evidence of improved satisfaction with pain relief. There is some evidence of an increase in opioid-related adverse events. As the sales of opioids have tripled from 1999-2008, so has the number of deaths caused by opioid overdose; 14,800 in 2008. The number of visits to the Emergency Department for opioid overdose doubled between 2004 and 2008. Patients in other countries take far less opioid pain medication and are equally satisfied with pain relief. For instance, Lindenhovius et al. found in a retrospective study that Dutch patients take a weak (Tramadol) or no opioid pain medication after ankle fracture surgery and have comparable or better satisfaction with pain relief than American patients, most of whom take oxycodone. That study was repeated prospectively (unpublished) and confirmed that Dutch patients do not feel their pain is undertreated. A study of morphine use after a femur fracture demonstrated that American patients used far more than Vietnamese patients (30 mg/kg versus 0.9 mg/kg), but were more dissatisfied with their pain relief. These sociological differences are striking and suggest strongly that personal factors may be the most important determinant of satisfaction with pain relief. It is our impression that most American hand surgeons give patients a prescription for an opioid pain medication after carpal tunnel release, and that is certainly true in our practice. This seems to be based primarily on the outliers, and intended to avoid confrontation with patients that desire opioids; however, most patients take little or no narcotic pain medication, and many who do use the opioids complain of the side effects—nausea and pruritis in particular. It is therefore not clear whether routine opioids is the optimal pain management strategy after carpal tunnel release. In the study of Stahl et al. from Israel, patients were prescribed acetaminophen rather than opioids after carpal tunnel release and only 20 of 50 patients used acetaminophen; 30 patients did not use acetaminophen or other pain medication at all after the operation. Our aim is to determine if there is a difference in satisfaction with pain relief between patients advised to take opioids compared to patients advised to use over the counter acetaminophen after carpal tunnel release under local anesthesia. A secondary aim is to determine if personal factors account for more of the variability in satisfaction with pain relief than opioid strategy.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Acetaminophen; Tramadol Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00210561 A Study of the Effectiveness and Safety of Tramadol HCl/Acetaminophen Compared to Placebo in Treating Acute Low Back Pain Terminated PriCara, Unit of Ortho-McNeil, Inc. Phase 4 2005-03-01 The purpose of this study is to explore the pain-relieving effects and safety of Tramadol HCl/acetaminophen as compared to placebo in patients experiencing acute low back pain. Tramadol HCl/acetaminophen is approved for short-term management of acute pain. The combination of tramadol HCl/acetaminophen has been shown to be effective for the treatment of acute musculoskeletal pain. Patients who experienced at least moderate acute low back pain for 2 to 10 days before study entry will be randomized to receive either tramadol HCl/acetaminophen or placebo.
NCT00210561 A Study of the Effectiveness and Safety of Tramadol HCl/Acetaminophen Compared to Placebo in Treating Acute Low Back Pain Terminated Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Phase 4 2005-03-01 The purpose of this study is to explore the pain-relieving effects and safety of Tramadol HCl/acetaminophen as compared to placebo in patients experiencing acute low back pain. Tramadol HCl/acetaminophen is approved for short-term management of acute pain. The combination of tramadol HCl/acetaminophen has been shown to be effective for the treatment of acute musculoskeletal pain. Patients who experienced at least moderate acute low back pain for 2 to 10 days before study entry will be randomized to receive either tramadol HCl/acetaminophen or placebo.
NCT00210847 A Study Comparing the Effectiveness and Safety of Tramadol HCl/Acetaminophen Versus Placebo for the Treatment of Painful Neuropathy in Diabetic Patients Completed PriCara, Unit of Ortho-McNeil, Inc. Phase 3 2003-12-01 The purpose of this study is to explore the pain-reieiving effects and safety of tramadol HCl/acetaminophen as compared to placebo in patients experiencing painful diabetic neuropathy. Treatment of neuropathic pain often requires the use of more than one medication. The pain-relieving potential of tramadol HCl/acetaminophen for the treatment of painful diabetic neuropathy comes from the multiple mechanisms of action in this combination pain medication. Patients who experience painful diabetic neuropathy will be enrolled in this study.
NCT00210847 A Study Comparing the Effectiveness and Safety of Tramadol HCl/Acetaminophen Versus Placebo for the Treatment of Painful Neuropathy in Diabetic Patients Completed Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Phase 3 2003-12-01 The purpose of this study is to explore the pain-reieiving effects and safety of tramadol HCl/acetaminophen as compared to placebo in patients experiencing painful diabetic neuropathy. Treatment of neuropathic pain often requires the use of more than one medication. The pain-relieving potential of tramadol HCl/acetaminophen for the treatment of painful diabetic neuropathy comes from the multiple mechanisms of action in this combination pain medication. Patients who experience painful diabetic neuropathy will be enrolled in this study.
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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Acetaminophen; Tramadol Hydrochloride

Condition Name

Condition Name for Acetaminophen; Tramadol Hydrochloride
Intervention Trials
Pain 10
Osteoarthritis 4
Postoperative Pain 4
Pain, Postoperative 4
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Condition MeSH

Condition MeSH for Acetaminophen; Tramadol Hydrochloride
Intervention Trials
Pain, Postoperative 12
Osteoarthritis 7
Chronic Pain 7
Low Back Pain 5
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Clinical Trial Locations for Acetaminophen; Tramadol Hydrochloride

Trials by Country

Trials by Country for Acetaminophen; Tramadol Hydrochloride
Location Trials
United States 20
Korea, Republic of 5
Canada 5
Italy 4
Japan 3
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Trials by US State

Trials by US State for Acetaminophen; Tramadol Hydrochloride
Location Trials
Texas 3
Minnesota 2
Massachusetts 2
Maryland 1
Utah 1
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Clinical Trial Progress for Acetaminophen; Tramadol Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Acetaminophen; Tramadol Hydrochloride
Clinical Trial Phase Trials
Phase 4 30
Phase 3 11
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Acetaminophen; Tramadol Hydrochloride
Clinical Trial Phase Trials
Completed 39
Recruiting 6
Terminated 4
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Clinical Trial Sponsors for Acetaminophen; Tramadol Hydrochloride

Sponsor Name

Sponsor Name for Acetaminophen; Tramadol Hydrochloride
Sponsor Trials
Janssen Korea, Ltd., Korea 10
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. 5
PriCara, Unit of Ortho-McNeil, Inc. 5
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Sponsor Type

Sponsor Type for Acetaminophen; Tramadol Hydrochloride
Sponsor Trials
Other 36
Industry 35
U.S. Fed 2
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