CLINICAL TRIALS PROFILE FOR VICODIN HP

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 That study was repeated prospectively (unpublished) and confirmed that Dutch patients do not feel their pain is undertreated.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

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	Withdrawn	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	Withdrawn	University of Minnesota	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	Withdrawn	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.

Clinical Trial Conditions for Vicodin Hp

Condition Name

Condition Name for Vicodin Hp
Intervention	Trials
Pain	10
Pain, Postoperative	3
Chronic Low Back Pain	3
Osteoarthritis	3

Condition MeSH

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

Clinical Trial Locations for Vicodin Hp

Trials by Country

Trials by Country for Vicodin Hp
Location	Trials
United States	169
Canada	1

Trials by US State

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

Clinical Trial Progress for Vicodin Hp

Clinical Trial Phase

Clinical Trial Phase for Vicodin Hp
Clinical Trial Phase	Trials
Phase 4	14
Phase 3	8
Phase 2	7

Clinical Trial Status

Clinical Trial Status for Vicodin Hp
Clinical Trial Phase	Trials
Completed	28
Withdrawn	4
Terminated	3

Clinical Trial Sponsors for Vicodin Hp

Sponsor Name

Sponsor Name for Vicodin Hp
Sponsor	Trials
Abbott	8
AbbVie (prior sponsor, Abbott)	2
Baylor College of Medicine	2

Sponsor Type

Sponsor Type for Vicodin Hp
Sponsor	Trials
Other	30
Industry	17
NIH	5

Vicodin HP: Clinical Trials, Market Analysis, and Projections

Introduction

Vicodin HP, a combination of hydrocodone bitartrate and acetaminophen, is a potent opioid analgesic used for the relief of moderate to moderately severe pain. Despite its effectiveness, the drug has faced significant regulatory and market changes. Here, we will delve into the clinical trials, market analysis, and projections for Vicodin HP.

Clinical Trials and Efficacy

Efficacy in Pain Management

Clinical trials have consistently shown that Vicodin HP is effective in managing moderate to moderately severe pain. The drug combines the opioid analgesic hydrocodone with the non-opioid analgesic and antipyretic acetaminophen, targeting two pain mechanisms to provide comprehensive pain relief[2][3].

Specific Studies

• In studies involving patients with chronic moderate to severe pain, hydrocodone-based formulations, such as HYDRO ER (an extended-release version of hydrocodone), have demonstrated significant pain reduction. For example, a 12-week multicenter, double-blind, randomized withdrawal design study showed that patients receiving HYDRO ER had significantly lower pain scores compared to those on placebo[4].

Safety and Adverse Reactions

Clinical trials have also highlighted the common adverse reactions associated with Vicodin HP, which include nausea, vomiting, constipation, dizziness, and respiratory and CNS depression. These side effects are typical of opioid analgesics and necessitate careful patient monitoring[2][4].

Market Analysis

Regulatory Changes

The market for Vicodin HP has been impacted by regulatory changes. By 2014, the FDA mandated that hydrocodone and acetaminophen products should not contain more than 325 mg of acetaminophen per dose to mitigate the risk of severe liver damage. This led to the discontinuation of the Vicodin HP brand name in the U.S., although generic versions remain available[3].

Market Trends

The opioid market has been under scrutiny due to concerns about addiction, abuse, and misuse. As a result, there has been a shift towards abuse-deterrent formulations. For instance, HYDRO ER, an extended-release hydrocodone product with abuse-deterrent properties, has been approved and is considered for patients requiring continuous, long-term opioid treatment where other options are inadequate[4].

Competition and Alternatives

The market for pain management is highly competitive, with various opioid and non-opioid alternatives available. The introduction of extended-release and abuse-deterrent formulations has expanded the treatment options for chronic pain management. However, the use of Vicodin HP and similar opioids is strictly regulated due to their potential for abuse and dependence[2][4].

Projections

Future Demand

Despite the regulatory challenges and competition, there is a persistent demand for effective pain management solutions. Vicodin HP, in its generic forms, is likely to remain a part of this landscape due to its established efficacy. However, future demand will be influenced by ongoing efforts to develop safer, abuse-deterrent opioid formulations and alternative pain management strategies[3].

Market Growth

The global pain management market is expected to grow, driven by an increasing prevalence of chronic pain conditions and an aging population. While Vicodin HP may not be a dominant player in this growing market due to its discontinued brand status and regulatory restrictions, generic versions and similar hydrocodone-based products will continue to play a role[4].

Patient and Prescriber Considerations

Patient Safety

Given the risks associated with opioids, patient safety is a paramount concern. Prescribers must carefully evaluate patients for the potential benefits and risks of Vicodin HP, especially in vulnerable populations such as the elderly, those with severe hepatic or renal impairment, and pregnant women[1][2][5].

Monitoring and Counseling

Regular monitoring of patients on Vicodin HP is crucial to manage potential side effects and prevent misuse. Patient counseling on the proper use of the medication, the risks of addiction, and the importance of adhering to the prescribed dosage is essential[2][5].

Key Takeaways

• Efficacy: Vicodin HP is effective in managing moderate to moderately severe pain.
• Regulatory Changes: The FDA has mandated that hydrocodone and acetaminophen products contain no more than 325 mg of acetaminophen per dose.
• Market Trends: There is a shift towards abuse-deterrent formulations and alternative pain management strategies.
• Future Demand: Generic versions of Vicodin HP will continue to be used, but with strict regulation and monitoring.
• Patient Safety: Careful patient evaluation and regular monitoring are critical to ensure safe use.

FAQs

Q: What is Vicodin HP used for?

A: Vicodin HP is used for the relief of moderate to moderately severe pain.

Q: What are the common side effects of Vicodin HP?

A: Common side effects include nausea, vomiting, constipation, dizziness, and respiratory and CNS depression.

Q: Why was the Vicodin HP brand name discontinued?

A: The Vicodin HP brand name was discontinued due to regulatory changes and the availability of generic versions.

Q: Can Vicodin HP be used in pregnant women?

A: Vicodin HP should be used in pregnant women only if the potential benefit justifies the potential risk to the fetus, as it falls under Pregnancy Category C[1].

Q: How should patients on Vicodin HP be monitored?

A: Patients should be regularly monitored for side effects, and their dosage should be adjusted cautiously, especially in vulnerable populations[1][2][5].