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Last Updated: April 6, 2025

CLINICAL TRIALS PROFILE FOR COLCHICINE; PROBENECID


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All Clinical Trials for COLCHICINE; PROBENECID

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT05499312 ↗ An Innovative Chinese Herbal Formula for the Treatment of Gout Not yet recruiting Chinese University of Hong Kong Phase 2 2022-09-01 Gout is a chronic disease of deposition of monosodium urate crystals, which form in the presence of increased urate concentrations. Gout is closely related to hyperuricaemia. Urate deposits in the joint, causing joint swelling, pain, movement disorders, affecting a significant portion of the population worldwide annually. The underlying pathophysiology of gout is multifactorial, complex, and poorly understood. Thus, gout remains one of the major therapeutic challenges. Currently, western medicine treatment of gout flare includes colchicine, NSAIDs and glucocorticoids. These drugs act as analgesics, anti-inflammatory and uric acid lowering drugs. Besides, management of gout and prevention of acute flares of gout make a crucial part in gout management. To obtain uricemia target, urate lowering treatment (ULT) has been widely used in conventional management of gout. Allopurinol, probenecid and febuxostat are some of the examples of ULT. Although researchers have carried out various studies on this disease, there are severe side effects for patients with gout. Therefore, it is necessary to explore new treatments for gout with good efficacy and less side effects. Chinese medicine (CM) is nowadays widely used for managing gout in China and other East Asian countries. Our principal Investigator (Prof. Zhi-xiu Lin), a highly experienced Registered Chinese Medicine Practitioner working at the School of Chinese Medicine, The Chinese University of Hong Kong, has been using a herbal formula (HKIIM-KU formula) to treat patients with gout in Hong Kong for many years. This formula has been observed to be effective in relieving and preventing gout and its related clinical manifestations. Hence, a double-blind, randomized, placebo-controlled, multicenter clinical trial will be employed in this study, and it would be able to provide robust clinical evidence on the efficacy and safety of HKIIM-KU formula for gout.
NCT01021020 ↗ Bioequivalence Study of Colchicine Tablets Completed Mutual Pharmaceutical Company, Inc. Phase 1 2007-09-01 This randomized, single dose, three-way crossover study will evaluate the bioequivalence of two formulations of colchicine, the test product (colchicine 0.6mg Mutual) and a marketed combination product (colchicine 0.5 mg with probenecid 500 mg), administered under fasting conditions. It will also determine the bioavailability following a standard high-fat meal and evaluate the safety and tolerability of the test product.
>Trial ID>Title>Status>Phase>Start Date>Summary
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Clinical Trial Conditions for COLCHICINE; PROBENECID

Condition Name

110-0.100.10.20.30.40.50.60.70.80.911.1GoutHealthy[disabled in preview]
Condition Name for COLCHICINE; PROBENECID
Intervention Trials
Gout 1
Healthy 1
[disabled in preview] 0
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Condition MeSH

10-0.100.10.20.30.40.50.60.70.80.911.1Gout[disabled in preview]
Condition MeSH for COLCHICINE; PROBENECID
Intervention Trials
Gout 1
[disabled in preview] 0
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Clinical Trial Locations for COLCHICINE; PROBENECID

Trials by Country

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Trials by Country for COLCHICINE; PROBENECID
Location Trials
United States 1
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Trials by US State

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Trials by US State for COLCHICINE; PROBENECID
Location Trials
North Dakota 1
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Clinical Trial Progress for COLCHICINE; PROBENECID

Clinical Trial Phase

50.0%50.0%0-0.100.10.20.30.40.50.60.70.80.911.1Phase 2Phase 1[disabled in preview]
Clinical Trial Phase for COLCHICINE; PROBENECID
Clinical Trial Phase Trials
Phase 2 1
Phase 1 1
[disabled in preview] 0
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Clinical Trial Status

50.0%50.0%0-0.100.10.20.30.40.50.60.70.80.911.1CompletedNot yet recruiting[disabled in preview]
Clinical Trial Status for COLCHICINE; PROBENECID
Clinical Trial Phase Trials
Completed 1
Not yet recruiting 1
[disabled in preview] 0
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Clinical Trial Sponsors for COLCHICINE; PROBENECID

Sponsor Name

trials000001111111Mutual Pharmaceutical Company, Inc.Chinese University of Hong Kong[disabled in preview]
Sponsor Name for COLCHICINE; PROBENECID
Sponsor Trials
Mutual Pharmaceutical Company, Inc. 1
Chinese University of Hong Kong 1
[disabled in preview] 0
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Sponsor Type

50.0%50.0%0-0.100.10.20.30.40.50.60.70.80.911.1IndustryOther[disabled in preview]
Sponsor Type for COLCHICINE; PROBENECID
Sponsor Trials
Industry 1
Other 1
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Colchicine and Probenecid: Clinical Trials, Market Analysis, and Projections

Introduction

Colchicine and probenecid are medications commonly used in the management of gout and other related conditions. This article delves into the current state of clinical trials, market analysis, and future projections for these drugs.

Clinical Trials and Efficacy

Colchicine in Gout Management

Colchicine is a well-established treatment for gout, particularly for acute gouty attacks and chronic gouty arthritis. It works by inhibiting microtubule polymerization, which reduces inflammation and pain associated with gout[1].

Colchicine in COVID-19

Recent clinical trials have explored the potential of colchicine in reducing inflammation in COVID-19 patients. The Colchicine Cardiovascular Outcomes Trial (COLCOT) suggested that colchicine could be beneficial for secondary prevention after myocardial infarction and potentially in managing COVID-19 symptoms. However, the efficacy of colchicine in COVID-19 is still under investigation through systematic reviews and meta-analyses[2][4].

Probenecid-Colchicine Combination

The combination of probenecid and colchicine is used to enhance the uricosuric effect of probenecid, helping to reduce uric acid levels in the body. This combination is particularly effective for patients with chronic gouty arthritis[1].

Market Analysis

Global Market Size and Growth

The global colchicine market is projected to reach USD 2,552.84 million by 2030, with a revenue CAGR of 8.4%. This growth is driven by increasing incidences of gout, Familial Mediterranean Fever (FMF), and other related diseases. The solid dosage form of colchicine, which is preferred for its ease of preparation and stability, accounts for the largest revenue share[3].

Regional Market Trends

North America and the Asia Pacific are key regions driving the growth of the colchicine market. In North America, the increasing prevalence of gout and pain-related disorders contributes significantly to market growth. The Asia Pacific region is expected to register a robust revenue CAGR due to increasing research and development activities and a growing geriatric population[3].

Pricing and Accessibility

The pricing of colchicine has been a significant issue, particularly in the U.S. The approval of Colcrys in 2009 led to a drastic increase in prices, resulting in a virtual monopoly. Public spending on colchicine has grown exponentially, mainly due to price increases after Colcrys’s approval and market exclusivity. This has made the drug less accessible to many patients, with Medicaid spending on single-ingredient colchicine rising by 2833% between 2008 and 2017[2][5].

Market Projections

Increasing Clinical Studies

The number of clinical trials for colchicine has increased dramatically, focusing on its therapeutic potential in various conditions, including cardiovascular diseases, COVID-19, and FMF. This trend is expected to continue, driving the development of new medicines and therapeutic alternatives[3].

Competitive Landscape

The market is competitive, with multiple generics available, but the prices of these generics are often set by brand-name companies, keeping them higher than previous unapproved formulations. The solid dosage form of colchicine is expected to continue contributing a major revenue share due to its stability and ease of handling[3].

Application Segments

The Familial Mediterranean Fever segment is expected to account for a substantially large revenue share during the forecast period. Colchicine is highly effective in preventing FMF and the development of amyloidosis, making accurate diagnosis and treatment critical[3].

Safety and Side Effects

Common Adverse Reactions

Both colchicine and probenecid can cause several adverse reactions. Common side effects include headache, dizziness, GI upset, diarrhea, and urinary frequency. More severe reactions can include blood dyscrasias, hemolytic anemia, and severe allergic reactions[1].

Contraindications

Colchicine is contraindicated in acute gouty attacks, blood dyscrasias, uric acid kidney stones, children under 2 years of age, pregnancy, and concomitant use with salicylates. Patients with a history of peptic ulcer, spastic colon, or other GI, renal, hepatic, or hematological disorders should use these medications with caution[1].

Patient Counseling and Monitoring

Long-Term Therapy

Patients on long-term therapy with colchicine and probenecid need regular monitoring of blood counts and renal function. Maintaining adequate hydration and alkalization of urine may be required. Debilitated and elderly patients, as well as nursing mothers, should be closely monitored[1].

Key Takeaways

  • Clinical Trials: Colchicine is being investigated for its potential in managing COVID-19 and other conditions beyond gout.
  • Market Growth: The global colchicine market is expected to grow significantly, driven by increasing incidences of gout and other related diseases.
  • Pricing Issues: The U.S. market has seen exponential price increases for colchicine, affecting accessibility.
  • Safety and Monitoring: Patients on these medications need regular monitoring for adverse reactions and contraindications.

FAQs

What is the primary use of colchicine and probenecid?

Colchicine and probenecid are primarily used to manage chronic gouty arthritis by reducing uric acid levels and inflammation.

How has the pricing of colchicine changed over the years?

The approval of Colcrys in 2009 led to a significant increase in colchicine prices, resulting in a virtual monopoly and exponential growth in public spending.

What are the common side effects of colchicine and probenecid?

Common side effects include headache, dizziness, GI upset, diarrhea, and urinary frequency. More severe reactions can include blood dyscrasias and severe allergic reactions.

Are there any contraindications for using colchicine?

Yes, colchicine is contraindicated in acute gouty attacks, blood dyscrasias, uric acid kidney stones, children under 2 years of age, pregnancy, and concomitant use with salicylates.

What regions are driving the growth of the colchicine market?

North America and the Asia Pacific are key regions driving the growth of the colchicine market due to increasing incidences of gout and other related diseases.

References

  1. Probenecid + Colchicine Prescription & Dosage Information - MPR
  2. Colchicine, Investigative Drug for COVID-19, Much More Expensive in US - US Pharmacist
  3. Colchicine Market Growth 2022-2030: Increasing Clinical Studies of Colchicine Drugs for Various Applications - BioSpace
  4. The evidence from clinical trials on Gout medicines effect on COVID-19: A protocol for systematic review and meta-analysis - Wiley Online Library
  5. Prolonged Increases in Public-Payer Spending and Prices After Approval of Colcrys - JAMA Internal Medicine

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