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Last Updated: February 17, 2025

CLINICAL TRIALS PROFILE FOR ROFECOXIB


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All Clinical Trials for Rofecoxib

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00004845 ↗ A Multicenter Trial of Rofecoxib and Naproxen in Alzheimer's Disease (NSAID Study) Completed Alzheimer's Disease Cooperative Study (ADCS) Phase 2/Phase 3 1969-12-31 The primary specific aim of this clinical trial is to determine whether treatment with rofecoxib or naproxen for one year will slow the rate of decline of cognitive function in patients with Alzheimer's disease (AD) as measured by ADAScog.
NCT00004845 ↗ A Multicenter Trial of Rofecoxib and Naproxen in Alzheimer's Disease (NSAID Study) Completed National Institute on Aging (NIA) Phase 2/Phase 3 1969-12-31 The primary specific aim of this clinical trial is to determine whether treatment with rofecoxib or naproxen for one year will slow the rate of decline of cognitive function in patients with Alzheimer's disease (AD) as measured by ADAScog.
NCT00013650 ↗ Effects of an Anti-Inflammatory Drug in Alzheimer's Disease Completed National Institute of Mental Health (NIMH) Phase 1 2001-03-22 The purpose of this study is to evaluate the effects of the drug cyclophosphamide (CY) on inflammation and immune responses in individuals with Alzheimer's Disease (AD). Inflammation and immunologic response appear to contribute to neurodegeneration in people with AD. In a process called gliosis, the brain immune cells microglia and astroglia undergo activation and possible proliferation, which promotes neuronal injury and death. Activated microglia and astroglia produce compounds that are cytotoxic to neurons, and they express molecules that greatly amplify immune and inflammatory processes in the brain. Excessive glial activation and proliferation are thought to be pivotal events that hasten the demise of synapses and neurons in AD. Fortunately, increased understanding of immune and inflammatory pathology in AD has provided new opportunities for designing disease-altering treatments for AD. Studies suggest that medications such as nonsteroidal anti-inflammatory drugs (NSAIDs) and immunomodulatory agents may have an important role in altering the course of AD. CY is a potent anti-inflammatory and immunomodulatory drug that inhibits proliferation of immune cells. This study will evaluate the effects of CY on individuals with mild to moderate AD. Participants in this study will be randomly assigned to receive either two different doses of CY or placebo (an inactive pill) for 6 months. Participants who receive placebo during the 6 months will have the option of receiving CY for an additional 6 months. Participants will undergo magnetic resonance imaging (MRI) scans of the brain. Measures of cerebral spinal fluid biomarkers or neurodegeneration, neuroinflammation, and neuroimmune activation will be taken. In addition, peripheral lymphocyte subsets and peripheral markers of inflammation will be assessed.
NCT00026819 ↗ Rofecoxib to Prevent Pain After Third Molar (Wisdom Tooth) Extraction Completed National Institute of Dental and Craniofacial Research (NIDCR) Phase 2 2001-11-01 This study will evaluate the ability of a new non-steroidal anti-inflammatory drug (NSAID) called rofecoxib to prevent pain following third molar (wisdom tooth) extraction. The Food and Drug Administration approved rofecoxib in 1999 to treat the symptoms of arthritis, menstrual cramps, and pain. Healthy normal volunteers between 16 and 35 years of age in general good health who require third molar (wisdom tooth) extraction may be eligible for this study. Candidates will be screened with a medical history and oral examination, including dental x-rays as needed to confirm the need for third molar removal. Participants will have all four wisdom teeth extracted, and a biopsy (removal of a small piece of tissue) will be taken from the inside of the cheek around the area behind the lower wisdom tooth. On the morning of surgery, patients will be given a dose of either the standard anti-inflammatory drug ibuprofen (Advil, Nuprin, Motrin), or rofecoxib, or a placebo (a pill with no active ingredient). Before surgery, they will be given a local anesthetic (lidocaine) in the mouth and a sedative (midazolam) through an arm vein. After the surgery, patients will remain in the clinic for up to 4 hours to monitor pain and the effects of the drug. Patients will complete pain questionnaires. Patients whose pain is unrelieved an hour after surgery may request and receive morphine intravenously (through a vein). After 4 hours, patients will be discharged with additional pain medicines (Tylenol with codeine and the study drug) and instructions for their use. They will also be given a pain diary to record pain ratings and medications taken at home. A clinic staff member will telephone patients at home the morning after surgery to ensure they are rating their pain intensity at the proper time and are taking their medications as instructed. Patients will return to the clinic 48 hours after surgery with the pain diary and pain relievers. At this visit, another biopsy will be taken under local anesthetic.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Rofecoxib

Condition Name

Condition Name for Rofecoxib
Intervention Trials
Osteoarthritis 5
Postoperative Pain 5
Pain 4
Headache 2
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Condition MeSH

Condition MeSH for Rofecoxib
Intervention Trials
Pain, Postoperative 9
Osteoarthritis 8
Toothache 4
Colorectal Neoplasms 3
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Clinical Trial Locations for Rofecoxib

Trials by Country

Trials by Country for Rofecoxib
Location Trials
United States 43
Italy 15
Brazil 11
Canada 3
Australia 3
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Trials by US State

Trials by US State for Rofecoxib
Location Trials
Maryland 4
Texas 3
Pennsylvania 2
Ohio 2
New York 2
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Clinical Trial Progress for Rofecoxib

Clinical Trial Phase

Clinical Trial Phase for Rofecoxib
Clinical Trial Phase Trials
Phase 4 12
Phase 3 15
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Rofecoxib
Clinical Trial Phase Trials
Completed 28
Terminated 8
Unknown status 2
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Clinical Trial Sponsors for Rofecoxib

Sponsor Name

Sponsor Name for Rofecoxib
Sponsor Trials
Merck Sharp & Dohme Corp. 18
National Institute of Dental and Craniofacial Research (NIDCR) 2
Johnson & Johnson Consumer and Personal Products Worldwide 2
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Sponsor Type

Sponsor Type for Rofecoxib
Sponsor Trials
Industry 25
Other 16
NIH 5
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Rofecoxib: A Comprehensive Review of Clinical Trials, Market Analysis, and Projections

Introduction

Rofecoxib, known by its brand name Vioxx, was a widely used nonsteroidal anti-inflammatory drug (NSAID) developed by Merck. It was specifically designed as a selective COX-2 inhibitor to reduce gastrointestinal side effects associated with traditional NSAIDs. However, its history was marked by significant controversy and safety concerns, leading to its withdrawal from the market in 2004. Here, we will delve into the clinical trials, market analysis, and projections for rofecoxib.

Clinical Trials and Safety Concerns

Early Trials and Efficacy

Rofecoxib was tested in numerous clinical trials for various indications, including osteoarthritis, rheumatoid arthritis, and the prevention of colorectal cancer. These trials generally showed that rofecoxib was effective in reducing pain and inflammation, but they also began to reveal a concerning pattern of cardiovascular adverse events[1][3][4].

Cardiovascular Risks

The most pivotal trial highlighting the cardiovascular risks associated with rofecoxib was the Adenomatous Polyp Prevention on Vioxx (APPROVe) trial. This long-term placebo-controlled trial demonstrated a relative risk of approximately two for serious adverse cardiovascular events, such as heart attacks and strokes, compared to placebo. The risk became more pronounced after 18 months of treatment[3].

Cumulative Pooled Analysis

A comprehensive pooled analysis of 30 randomized, placebo-controlled trials involving over 20,000 subjects further substantiated these findings. By December 2000, the data already indicated a higher risk of cardiovascular thromboembolic (CVT) adverse events and deaths among patients taking rofecoxib compared to those on placebo[1].

Other Trials and Outcomes

Other trials, such as the Vioxx in Colorectal Cancer Therapy: Definition of Optimal Regime (VICTOR) trial and the Vioxx in Prostate Cancer Prevention study, were terminated early due to the drug's withdrawal from the market. These trials did not show any significant benefit of rofecoxib in reducing cancer recurrence or improving survival, while also highlighting the drug's cardiovascular risks[1][4].

Market Analysis and Projections

Historical Market Context

Rofecoxib was a significant player in the pharmaceutical market before its withdrawal. However, due to its removal from the market, current market reports do not include rofecoxib as an active product.

Current Market Reports

The global market reports for rofecoxib are now more of a historical analysis rather than a forward-looking projection. These reports typically cover the period up to 2004 and provide insights into the market size, revenue, and growth rate before the drug's withdrawal[2].

Competitive Landscape

Prior to its withdrawal, Merck was the primary manufacturer of rofecoxib. Other companies mentioned in market reports, such as Hubei TuoChu Kang Yuan Pharmaceutical Chemical Co. LTD and Pfizer, are not associated with rofecoxib but are part of the broader NSAID market[2].

Regional Analysis

Market reports often segment the pharmaceutical market by region, including North America, Europe, Asia Pacific, South America, and the Middle East & Africa. However, these analyses are more relevant to current and future market trends rather than historical products like rofecoxib[2].

Projections and Future Outlook

No Future Projections

Given the voluntary withdrawal of rofecoxib from the market due to safety concerns, there are no future projections or market analyses that include this drug. The focus has shifted to other safer alternatives within the NSAID and COX-2 inhibitor classes.

Lessons Learned

The rofecoxib saga serves as a critical example for postmarket pharmaceutical safety surveillance. It highlights the importance of continuous monitoring of drug safety and the need for transparent reporting of clinical trial data to protect public health[1][3].

Key Takeaways

  • Rofecoxib was withdrawn from the market in 2004 due to increased cardiovascular risks.
  • Clinical trials, particularly the APPROVe trial, demonstrated a significant risk of cardiovascular adverse events.
  • Market reports now treat rofecoxib as a historical product with no future projections.
  • The incident has emphasized the importance of rigorous postmarket surveillance and transparent clinical trial data reporting.

FAQs

What was the primary reason for the withdrawal of rofecoxib from the market?

The primary reason for the withdrawal of rofecoxib was the increased risk of serious cardiovascular adverse events, such as heart attacks and strokes, as revealed by several clinical trials.

Which trial was most pivotal in highlighting the cardiovascular risks of rofecoxib?

The Adenomatous Polyp Prevention on Vioxx (APPROVe) trial was the most pivotal in highlighting the cardiovascular risks associated with rofecoxib.

What were the indications for which rofecoxib was tested in clinical trials?

Rofecoxib was tested for various indications, including osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, acute pain conditions, migraine, dysmenorrhea, and the prevention of colorectal cancer.

Are there any current market projections for rofecoxib?

No, there are no current market projections for rofecoxib since it was withdrawn from the market in 2004.

What lessons can be learned from the rofecoxib experience?

The rofecoxib experience emphasizes the importance of continuous monitoring of drug safety, transparent reporting of clinical trial data, and rigorous postmarket surveillance to protect public health.

Which companies were involved in the production of rofecoxib?

Merck was the primary manufacturer of rofecoxib. Other companies mentioned in market reports are not associated with rofecoxib but are part of the broader pharmaceutical industry.

Sources

  1. Pooled Analysis of Rofecoxib Placebo-Controlled Clinical Trial Data - JAMA Internal Medicine
  2. Rofecoxib Market Report 2024 (Global Edition) - Cognitive Market Research
  3. Decisional Summary - FDA - FDA
  4. Phase III Randomized Trial Assessing Rofecoxib in the Adjuvant Treatment of Colorectal Cancer - Journal of Clinical Oncology

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