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Last Updated: February 15, 2025

CLINICAL TRIALS PROFILE FOR CLEOCIN HYDROCHLORIDE


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All Clinical Trials for Cleocin Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00503542 ↗ Management of Vaginal Complaints: A Pilot Study Within a Practice-Based Research Network Completed Agency for Healthcare Research and Quality (AHRQ) Early Phase 1 2007-02-01 Many women present in primary care with vaginal complaints. The best way of managing these complaints is unclear. This trial will test two different methods of managing patients with vaginal complaints. This is a pilot trial.
NCT00836004 ↗ Clindamycin 300 mg Capsules in Healthy Subjects Under Fed Conditions Completed Teva Pharmaceuticals USA Phase 1 2003-11-01 The objective of this study is to compare the rate and extent of absorption of clindamycin 300 mg capsules (test) versus Cleocin HCl (reference, administered as 1 x 300 mg capsule under fed conditions.
NCT00836056 ↗ Clindamycin 300 mg Capsules in Healthy Subjects Under Fasting Conditions Completed Teva Pharmaceuticals USA Phase 1 2003-11-01 The objective of this study is to compare the rate and extent of absorption of clindamycin 300 mg capsules (test) versus Cleocin HCl (reference), administered as 1 x 300 mg capsule under fasting conditions.
NCT01132443 ↗ W0261-101: A Phase 1, Single Center, Randomized, Open-Label Study to Evaluate the Bioavailability of Clindamycin From Clindamycin 1%-Benzoyl Peroxide 3% Gel, Topical Gel (Clindamycin 1%- Benzoyl Peroxide 5%), and Once Daily Gel (Clindamycin 1%-Benzo Completed GlaxoSmithKline Phase 1 2010-05-06 This study was conducted to determine if the bioavailability of clindamycin and its metabolite clindamycin sulfoxide are altered by the concentration of BPO or the absence of methylparaben. This study compared the investigational study product and 2 marketed products: - CLN 1%-BPO 3% Gel (clindamycin 1%-BPO 3%), methylparaben-free - Topical Gel (clindamycin 1%-BPO 5%), methylparaben-preserved (Topical Gel-MP) - Once Daily Gel ((clindamycin 1%-BPO 5%), methylparaben-free (Topical Gel-MPF)
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Cleocin Hydrochloride

Condition Name

Condition Name for Cleocin Hydrochloride
Intervention Trials
Healthy 2
Anti-bacterial Agents 1
Capsular Contracture Associated With Breast Implant 1
Vaginitis 1
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Condition MeSH

Condition MeSH for Cleocin Hydrochloride
Intervention Trials
Bacterial Infections 3
Communicable Diseases 2
Infections 2
Infection 2
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Clinical Trial Locations for Cleocin Hydrochloride

Trials by Country

Trials by Country for Cleocin Hydrochloride
Location Trials
United States 6
Canada 2
China 1
India 1
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Trials by US State

Trials by US State for Cleocin Hydrochloride
Location Trials
New York 3
Michigan 1
Illinois 1
Arkansas 1
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Clinical Trial Progress for Cleocin Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Cleocin Hydrochloride
Clinical Trial Phase Trials
Phase 4 5
Phase 1 4
N/A 1
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Clinical Trial Status

Clinical Trial Status for Cleocin Hydrochloride
Clinical Trial Phase Trials
Completed 7
Not yet recruiting 2
Recruiting 1
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Clinical Trial Sponsors for Cleocin Hydrochloride

Sponsor Name

Sponsor Name for Cleocin Hydrochloride
Sponsor Trials
Teva Pharmaceuticals USA 2
The Plastic Surgery Foundation 1
University of Missouri-Columbia 1
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Sponsor Type

Sponsor Type for Cleocin Hydrochloride
Sponsor Trials
Other 11
Industry 4
NIH 2
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Cleocin Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Cleocin Hydrochloride

Cleocin Hydrochloride, commonly known by its generic name clindamycin, is a potent antibiotic belonging to the lincosamide class. It is widely used to treat various bacterial infections, including respiratory, skin and soft tissue, septicemia, intraabdominal, and bone and joint infections.

Mechanism of Action and Pharmacology

Clindamycin works by inhibiting bacterial protein synthesis. It binds to the 50S subunit of the ribosome, specifically to the 23S RNA, which is bacteriostatic, meaning it stops the growth of bacteria rather than killing them outright[1][4].

Clinical Uses and Indications

Cleocin Hydrochloride is prescribed for serious infections where less toxic antibiotics are not appropriate. It is effective against a range of infections, including:

  • Respiratory infections
  • Skin and soft tissue infections
  • Septicemia
  • Intraabdominal infections
  • Female pelvic or genital infections
  • Bone and joint infections[1].

Dosage and Administration

The dosage of Cleocin Hydrochloride varies based on the severity of the infection and the patient's age. For adults, the typical dose is 150-300 mg every 6 hours for serious infections, and up to 300-450 mg every 6 hours for more severe cases. For children, the dose is 8-16 mg/kg per day for serious infections and 16-20 mg/kg per day for more severe infections, divided into 3-4 equal doses[1].

Adverse Reactions and Warnings

Cleocin Hydrochloride is associated with several adverse reactions, including pseudomembranous colitis, C. difficile-associated diarrhea, nausea, vomiting, abdominal pain, and severe skin reactions. It also carries a boxed warning for the risk of C. difficile-associated diarrhea and should be discontinued if colitis is suspected or confirmed[1].

Clinical Trials

While specific recent clinical trials on Cleocin Hydrochloride are not extensively detailed in the available sources, the drug has been a subject of various studies over the years. For instance, its efficacy in treating anaerobic infections and its role in surgical prophylaxis have been well-documented. Ongoing and future trials may focus on its use in combination therapies, topical formulations, and its application in veterinary medicine[2][5].

Market Analysis

The clindamycin hydrochloride market has been experiencing significant growth. As of 2023, the market size was $1.68 billion, and it is projected to increase to $1.82 billion in 2024, with a compound annual growth rate (CAGR) of 8.5%. This growth is driven by several factors:

  • Increasing incidence of bacterial infections
  • Growing use in treating anaerobic infections
  • Heightened awareness and diagnosis of skin and soft tissue infections
  • Rising endorsements by healthcare professionals due to its effectiveness against resistant strains[2][5].

Market Projections

The market for clindamycin hydrochloride is expected to continue its strong growth trajectory. By 2028, the market size is projected to reach $2.54 billion, with a CAGR of 8.6%. Key drivers of this growth include:

  • Advances in pharmaceutical formulations and delivery methods
  • Growing demand for targeted antibiotics with fewer side effects
  • Increasing investment in healthcare infrastructure and access to medications
  • Rising prevalence of antibiotic-resistant infections globally
  • Expanding use of clindamycin in emerging markets and veterinary medicine[2][5].

Trends in the Forecast Period

Several trends are expected to shape the future of the clindamycin hydrochloride market:

  • Shift Towards Combination Therapies: There is a growing trend towards using clindamycin in combination with other antibiotics to enhance efficacy.
  • Development of Topical Formulations: Clindamycin-based topical formulations are being developed to treat skin and soft tissue infections more effectively.
  • Strategic Partnerships and Acquisitions: Companies are engaging in strategic partnerships and acquisitions to increase their market presence.
  • Expansion in Veterinary Medicine: The use of clindamycin is expanding into veterinary medicine, further boosting market growth.
  • Personalized Medicine: There is a growing emphasis on personalized and tailored antibiotic treatments, which may include clindamycin[2][5].

Conclusion

Cleocin Hydrochloride remains a crucial antibiotic in the treatment of various bacterial infections. Its market is poised for significant growth driven by increasing demand, advances in pharmaceutical technology, and expanding applications. However, it is important to be aware of its potential adverse reactions and to use it judiciously.

Key Takeaways

  • Mechanism of Action: Cleocin Hydrochloride inhibits bacterial protein synthesis by binding to the 50S subunit of the ribosome.
  • Clinical Uses: It is used to treat serious bacterial infections, including respiratory, skin and soft tissue, and bone and joint infections.
  • Market Growth: The market size is expected to grow from $1.68 billion in 2023 to $2.54 billion by 2028, with a CAGR of 8.6%.
  • Trends: Shift towards combination therapies, development of topical formulations, strategic partnerships, expansion in veterinary medicine, and personalized medicine.
  • Adverse Reactions: Associated with pseudomembranous colitis, C. difficile-associated diarrhea, and severe skin reactions.

FAQs

Q: What is the mechanism of action of Cleocin Hydrochloride? A: Cleocin Hydrochloride inhibits bacterial protein synthesis by binding to the 23S RNA of the 50S subunit of the ribosome.

Q: What are the common indications for Cleocin Hydrochloride? A: It is used to treat serious bacterial infections such as respiratory, skin and soft tissue, septicemia, intraabdominal, female pelvic or genital, and bone and joint infections.

Q: What are the potential adverse reactions associated with Cleocin Hydrochloride? A: Adverse reactions include pseudomembranous colitis, C. difficile-associated diarrhea, nausea, vomiting, abdominal pain, and severe skin reactions.

Q: How is the market for Cleocin Hydrochloride expected to grow? A: The market is projected to grow from $1.68 billion in 2023 to $2.54 billion by 2028, with a CAGR of 8.6%.

Q: What are the key trends shaping the future of the clindamycin hydrochloride market? A: Trends include a shift towards combination therapies, development of topical formulations, strategic partnerships, expansion in veterinary medicine, and a growing emphasis on personalized medicine.

Sources

  1. CLEOCIN Prescription & Dosage Information - MPR - eMPR.com
  2. Global Clindamycin Hydrochloride Market Set For 8.6 % Growth, Reaching $2.54 Billion By 2028 - Ein Presswire
  3. U.S. clinical trials using Voltaren - Sage Journals (not directly relevant but mentioned for context)
  4. Clindamycin Hydrochloride - Drug Targets, Indications, Patents - Synapse
  5. Clindamycin Hydrochloride Global Market Report 2024 - The Business Research Company

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