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Last Updated: January 20, 2020

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CLINICAL TRIALS PROFILE FOR VICODIN HP

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505(b)(2) Clinical Trials for Vicodin Hp

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 That study was repeated prospectively (unpublished) and confirmed that Dutch patients do not feel their pain is undertreated.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 Vicodin Hp

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00174538 Codeine in Sickle Cell Disease Completed PriCara, Unit of Ortho-McNeil, Inc. Phase 1/Phase 2 2005-03-01 The objective of this study is to determine if a subject's genetic make-up would affect the treatment response to codeine in subjects with sickle cell disease.
NCT00195728 Long Term Safety and Tolerability Study in Approximately 350 Subjects With Moderate to Severe Chronic, Non-malignant Pain Completed Abbott Phase 3 2005-06-01 The purpose of the study is to evaluate the safety of Vicodin CR (combination opioid and acetaminophen containing product) in patients with chronic pain due to osteoarthritis or low back pain.
NCT00298974 A Study of Pain Relief in Osteoarthritis Completed Abbott Phase 3 2006-02-01 The purpose of this study is to compare the safety and pain-relieving ability of Vicodin CR to placebo in subjects with osteoarthritis (OA) of the hip or knee.
NCT00304317 Celecoxib (Celebrex) in the Management of Acute Renal Colic Terminated Pfizer Phase 4 2006-03-01 The purpose of this trial is to quantify the amount Celebrex, a specific cyclooxygenase-2 (COX-2) inhibitor, when used for the management of acute renal colic for a ureteral stone will: - reduce pain medication usage - improve the percentage of spontaneous stone passage - decrease the time to spontaneous passage, and - shift the size distribution of stones passed towards larger sizes
NCT00304317 Celecoxib (Celebrex) in the Management of Acute Renal Colic Terminated University of Minnesota - Clinical and Translational Science Institute Phase 4 2006-03-01 The purpose of this trial is to quantify the amount Celebrex, a specific cyclooxygenase-2 (COX-2) inhibitor, when used for the management of acute renal colic for a ureteral stone will: - reduce pain medication usage - improve the percentage of spontaneous stone passage - decrease the time to spontaneous passage, and - shift the size distribution of stones passed towards larger sizes
NCT00312572 Safety and Efficacy of Dose Conversion From Vicodin® to Buprenorphine Transdermal System (Butrans™) in Subjects With OA Pain Completed Purdue Pharma LP Phase 3 2003-06-01 The objective of this study is to evaluate the safety and efficacy of dose conversion from hydrocodone/ acetaminophen (Vicodin®) to the buprenorphine transdermal system (Butrans™) in subjects with osteoarthritis pain of the hip or knee. The double-blind treatment intervention duration is 2 weeks during which time supplemental analgesic medication will be allowed.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Vicodin Hp

Condition Name

Condition Name for Vicodin Hp
Intervention Trials
Pain 9
Pain, Postoperative 3
Osteoarthritis 3
Chronic Low Back Pain 3
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Condition MeSH

Condition MeSH for Vicodin Hp
Intervention Trials
Pain, Postoperative 5
Osteoarthritis 4
Low Back Pain 3
Back Pain 3
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Clinical Trial Locations for Vicodin Hp

Trials by Country

Trials by Country for Vicodin Hp
Location Trials
United States 163
Canada 1
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Trials by US State

Trials by US State for Vicodin Hp
Location Trials
Texas 10
Massachusetts 8
New York 7
Maryland 7
Florida 7
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Clinical Trial Progress for Vicodin Hp

Clinical Trial Phase

Clinical Trial Phase for Vicodin Hp
Clinical Trial Phase Trials
Phase 4 12
Phase 3 8
Phase 2 6
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Clinical Trial Status

Clinical Trial Status for Vicodin Hp
Clinical Trial Phase Trials
Completed 21
Not yet recruiting 5
Recruiting 4
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Clinical Trial Sponsors for Vicodin Hp

Sponsor Name

Sponsor Name for Vicodin Hp
Sponsor Trials
Abbott 8
AbbVie (prior sponsor, Abbott) 2
Maimonides Medical Center 1
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Sponsor Type

Sponsor Type for Vicodin Hp
Sponsor Trials
Other 24
Industry 17
NIH 5
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Serving leading biopharmaceutical companies globally:

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Mallinckrodt
Express Scripts
AstraZeneca
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