CLINICAL TRIALS PROFILE FOR COL-PROBENECID

All Clinical Trials for Col-probenecid

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000670 ↗	Safety and Tolerance of Zidovudine With Probenecid and the Effect of Probenecid on Zidovudine Pharmacokinetics Over Four Weeks	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To evaluate the interaction of probenecid with zidovudine (AZT). Because AZT is eliminated quickly from the body, it must be taken frequently. A previous study showed that probenecid slowed the elimination of AZT without side effects, but that study lasted only 5 days. This study is to see whether this effect continues for 1 month and whether the continuation of probenecid and AZT is free of side effects over 1 month.
NCT00000706 ↗	Influence of Probenecid and Quinine on the Pharmacokinetics of Azidothymidine	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	Part I studies the effect of quinine on how zidovudine (AZT) is used by the body and eliminated through the kidneys in HIV infected patients. Part II studies the effect of probenecid and quinine on the same aspects. Because AZT leaves the bloodstream quickly, patients must take the drug frequently to keep adequate amounts in their bodies. Probenecid and quinine may slow down the rate at which AZT leaves the body. Therefore, taking these drugs along with AZT may reduce the amount of AZT needed for treatment.
NCT00000799 ↗	HPMPC (Cidofovir) Peripheral CMV Retinitis Trial Protocol	Completed	Gilead Sciences	N/A	1969-12-31	To evaluate short-term and long-term safety and efficacy of intravenous cidofovir (HPMPC) for treatment of small peripheral cytomegalovirus (CMV) retinitis lesions. To provide data on the relative safety and efficacy of 2 doses of HPMPC as maintenance regimens.
NCT00000799 ↗	HPMPC (Cidofovir) Peripheral CMV Retinitis Trial Protocol	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To evaluate short-term and long-term safety and efficacy of intravenous cidofovir (HPMPC) for treatment of small peripheral cytomegalovirus (CMV) retinitis lesions. To provide data on the relative safety and efficacy of 2 doses of HPMPC as maintenance regimens.
NCT00000881 ↗	A Study of Cidofovir in HIV-Infected Children With Cytomegalovirus (CMV) Disease	Withdrawn	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	Part A: To determine the safety and pharmacokinetics of sequential single doses of cidofovir in HIV-infected children with end-organ cytomegalovirus (CMV) disease. Part B: To determine the safety (including time to progression of CMV retinitis by retinal exam), pharmacokinetics, and long-term (6 months) tolerance of multiple-dose cidofovir in HIV-infected children with CMV retinitis. Part B: To determine the effect of multiple-dose cidofovir on the virologic parameters of CMV retinitis (viral load, shedding, and resistance to antiviral agents). [AS PER AMENDMENT 1/7/98: To determine the safety, tolerance and pharmacokinetics of sequential single doses of cidofovir in HIV-infected children with CMV retinitis. To determine the safety (including time to progression of CMV retinitis by retinal exam), pharmacokinetics, and long-term (6-month) tolerance of multiple doses of cidofovir in HIV-infected children with CMV retinitis.] While the intravenous formulation of cidofovir has been approved for the treatment of CMV retinitis in HIV-infected individuals, information is limited regarding its safety and tolerance in HIV-infected children. Intravenous cidofovir requires less frequent administration for both induction and maintenance therapy of CMV retinitis than other currently available therapies. If found to be safe and well tolerated in HIV-infected children with CMV retinitis, intravenous cidofovir would add significantly to agents available to treat this debilitating opportunistic infection.
NCT00000894 ↗	Comparison of Two Drugs, Cidofovir and Ganciclovir, in Treating Patients With AIDS Who Have CMV Retinitis	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 4	1969-12-31	To compare cidofovir with a commonly used treatment regimen, ganciclovir given by mouth (oral) and through an eye device (intraocular) , in order to determine the safety and effectiveness of cidofovir in preventing vision loss in patients who have AIDS complicated by CMV (cytomegalovirus) retinitis. Cidofovir needs to be compared to ganciclovir to determine the best way to treat CMV retinitis.
NCT00000945 ↗	A Study to Evaluate the Use of Cidofovir (an Experimental Drug) for the Treatment of Progressive Multifocal Leukoencephalopathy (PML) in AIDS Patients	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	The purpose of this study is to evaluate the safety, tolerance, and overall effectiveness of cidovir to treat PML in AIDS patients. PML is an opportunistic infection (HIV-associated, due to weak immune system) caused by a virus that attacks the brain. Cidovir has been used effectively to treat cytomegalovirus (CMV) of the eye. Cidovir could be an effective treatment for PML as well.

Clinical Trial Conditions for Col-probenecid

Condition Name

Condition Name for Col-probenecid
Intervention	Trials
HIV Infections	10
Cytomegalovirus Retinitis	7
Healthy	6
Urinary Tract Infections	4

Condition MeSH

Condition MeSH for Col-probenecid
Intervention	Trials
HIV Infections	11
Communicable Diseases	8
Retinitis	7
Cytomegalovirus Retinitis	7

Clinical Trial Locations for Col-probenecid

Trials by Country

Trials by Country for Col-probenecid
Location	Trials
United States	195
Canada	10
Germany	6
South Africa	6
New Zealand	5

Trials by US State

Trials by US State for Col-probenecid
Location	Trials
California	16
Texas	13
Ohio	10
New York	10
Florida	8

Clinical Trial Progress for Col-probenecid

Clinical Trial Phase

Clinical Trial Phase for Col-probenecid
Clinical Trial Phase	Trials
Phase 4	6
Phase 3	10
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for Col-probenecid
Clinical Trial Phase	Trials
Completed	45
Not yet recruiting	11
Recruiting	6

Clinical Trial Sponsors for Col-probenecid

Sponsor Name

Sponsor Name for Col-probenecid
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	8
Iterum Therapeutics, International Limited	5
National Institutes of Health (NIH)	5

Sponsor Type

Sponsor Type for Col-probenecid
Sponsor	Trials
Industry	41
Other	34
NIH	21

Clinical Trials, Market Analysis, and Projections for Col-Probenecid

Introduction

Col-Probenecid, a combination drug consisting of colchicine and probenecid, has been a staple in the treatment of gout for several decades. This article will delve into the current clinical trials, market analysis, and future projections for this medication.

Clinical Trials and Efficacy

Historical Context

Col-Probenecid has a long history of use, with the FDA approving it for the "prophylactic treatment of gout flares" in the 1970s. The combination of 0.5 mg of colchicine and 500 mg of probenecid has been shown to be effective in managing chronic gouty arthritis, particularly in preventing frequent, recurrent acute attacks of gout[2].

Recent Studies

While there are no recent clinical trials specifically focused on Col-Probenecid, studies on its components provide valuable insights. For instance, the AGREE trial, which evaluated the efficacy, safety, and tolerability of colchicine in patients with acute gout flares, demonstrated that a low-dose regimen of colchicine was as effective as higher doses but with fewer adverse events[2].

Safety and Tolerability

Clinical trials have generally shown that Col-Probenecid is safe and well-tolerated. The combination of colchicine and probenecid helps in reducing the toxicity associated with higher doses of colchicine alone, as probenecid increases the plasma concentration of colchicine, allowing for lower doses of colchicine to be effective[2].

Market Analysis

Current Market

The global market for clinical trials, which includes drugs like Col-Probenecid, was valued at $48.2 billion in 2023. This market is projected to grow to $73.2 billion by 2028, driven by increasing investments in pharmaceutical R&D and a growing pipeline of drug candidates[3].

Therapeutic Area

The rheumatology segment, which includes treatments for gout, is a significant part of the clinical trials market. The high prevalence of gout and other rheumatological conditions continues to drive the demand for effective treatments like Col-Probenecid.

Regional Growth

The Asia Pacific region is expected to register the highest CAGR during the forecast period due to favorable government policies, low costs of clinical trials, and a large treatment population. This region is becoming a major destination for drug development and clinical research, which could impact the market for Col-Probenecid positively[3].

Market Projections

Growth Drivers

• Increasing Demand for Gout Treatments: The rising incidence of gout and the need for effective prophylactic treatments are expected to drive the demand for Col-Probenecid.
• Generic Market: Although the introduction of generics has not significantly reduced prices, the availability of generic versions of Col-Probenecid could increase accessibility and drive market growth[5].

Challenges

• Price Stability: Despite the introduction of generics, prices for colchicine and thus Col-Probenecid have remained high. This could limit affordability and impact market growth[5].
• Regulatory Environment: Changes in regulatory policies and market exclusivities can significantly impact the pricing and availability of Col-Probenecid.

Pricing Dynamics

Historical Pricing

The pricing of colchicine, a key component of Col-Probenecid, has been a subject of concern. The FDA-approved Colcrys, which entered the market in 2009, significantly increased the price of colchicine from less than 50 cents per pill to around $5 per pill. Even with the introduction of generics, prices have not decreased substantially[5].

Impact on Public Spending

The high prices of colchicine and Col-Probenecid have led to exponential growth in public spending. For example, Medicaid spending on colchicine increased by 2,833% since 2008, primarily due to price increases[5].

Future Outlook

Repurposing of Colchicine

Recent research suggests that colchicine could be repurposed for secondary prevention after myocardial infarction. This potential new indication could expand the market for Col-Probenecid, although it would depend on clinical trial outcomes and regulatory approvals[5].

Competitive Landscape

The market for gout treatments is competitive, with several drugs and combination therapies available. However, Col-Probenecid's established efficacy and safety profile make it a strong contender in this market.

Key Takeaways

• Clinical Efficacy: Col-Probenecid has been shown to be effective in managing chronic gouty arthritis.
• Market Growth: The global clinical trials market, including the segment for gout treatments, is expected to grow significantly.
• Pricing Concerns: High prices of colchicine and Col-Probenecid remain a challenge, affecting affordability and public spending.
• Future Potential: Potential repurposing of colchicine for new indications could expand the market for Col-Probenecid.

FAQs

What is Col-Probenecid used for?

Col-Probenecid is used for the prophylactic treatment of gout flares, combining 0.5 mg of colchicine and 500 mg of probenecid.

How effective is Col-Probenecid in clinical trials?

Clinical trials have shown that Col-Probenecid is effective in managing chronic gouty arthritis, with the combination reducing the toxicity associated with higher doses of colchicine alone[2].

Why have prices for colchicine and Col-Probenecid remained high despite the introduction of generics?

Prices have remained high due to market exclusivities and patents held by brand-name companies, which have set price points for authorized generics that are only slightly lower than the brand-name product[5].

What are the future market projections for Col-Probenecid?

The market for Col-Probenecid is expected to grow driven by increasing demand for gout treatments and potential new indications for colchicine. However, pricing dynamics and regulatory environments will play significant roles in shaping the market.

How does the Asia Pacific region impact the market for Col-Probenecid?

The Asia Pacific region is expected to register the highest CAGR in the clinical trials market due to favorable government policies, low costs, and a large treatment population, which could positively impact the market for Col-Probenecid[3].

Sources

1. MDPI: Oral Probenecid for Nonhospitalized Adults with Symptomatic Mild COVID-19.
2. govinfo.gov: Case 1:14-cv-01850-KBJ Document 16 Filed 01/12/15.
3. MarketsandMarkets: Clinical Trials Market Size, Share, Trends and Revenue Forecast.
4. FDA: FDA Approves New Treatment for Women with Uncomplicated UTIs.
5. Healio: Colchicine prices remain high despite introduction of generics.

Last updated: 2025-01-07