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Last Updated: February 17, 2020

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CLINICAL TRIALS PROFILE FOR CLINDAMYCIN HYDROCHLORIDE

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505(b)(2) Clinical Trials for Clindamycin Hydrochloride

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
New Dosage NCT02058628 Comparison of the Efficacy and Safety of Clindamycin + Benzoyl Peroxide Formulation With Azelaic Acid Formulation in the Treatment of Acne Vulgaris Completed GlaxoSmithKline Phase 4 2014-02-01 This is a randomized, comparator-controlled, single-blind, parallel-group study. The current study proposes to compare a fixed-dose combination product containing 3% benzoyl peroxide (BPO) and 1% clindamycin against a cream containing 20% azelaic acid for the treatment of facial acne vulgaris. The results of the study will enable a better assessment of the safety and efficacy of the new dose regime (BPO 3% + clindamycin 1%) in comparison to a well established treatment. Based on the data more evidence based recommendations will be possible to improve the treatment of subjects with acne vulgaris. A total of 220 subjects will be enrolled and will have 5 study visits (Day 1, Weeks 2, 4, 8 and 12). The duration of the study will be over 12 weeks.
New Formulation NCT03615768 A Study to Evaluate the Efficacy and Safety of Adapalene-Clindamycin Combination Gel in the Treatment of Acne Vulgaris Recruiting Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Limited Phase 3 2018-08-14 This is a study to see if Adapalene-Clindamycin Combination Gel is effective and safe in the treatment of acne vulgaris, compared to adapalene gel alone and clindamycin gel alone. Adapalene and clindamycin have been reported to have a better effect in acne treatment when used together. This new formulation is also easier to use as it combines two products into a single gel and only needs to be used once a day.
New Formulation NCT03615768 A Study to Evaluate the Efficacy and Safety of Adapalene-Clindamycin Combination Gel in the Treatment of Acne Vulgaris Recruiting Lee's Pharmaceutical Limited Phase 3 2018-08-14 This is a study to see if Adapalene-Clindamycin Combination Gel is effective and safe in the treatment of acne vulgaris, compared to adapalene gel alone and clindamycin gel alone. Adapalene and clindamycin have been reported to have a better effect in acne treatment when used together. This new formulation is also easier to use as it combines two products into a single gel and only needs to be used once a day.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Clindamycin Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000640 A Phase III Comparative Study of Dapsone / Trimethoprim and Clindamycin / Primaquine Versus Sulfamethoxazole / Trimethoprim in the Treatment of Mild-to-Moderate PCP in Patients With AIDS Completed Glaxo Wellcome Phase 3 1969-12-31 To evaluate the effectiveness of two oral treatments for mild to moderate Pneumocystis carinii pneumonia (PCP): dapsone/trimethoprim or clindamycin/primaquine as compared to a standard treatment program of sulfamethoxazole/trimethoprim (SMX/TMP) to assess the tolerance of these two alternative treatments as compared to the standard treatment of SMX/TMP. Per 09/09/92 amendment, to assess the efficacy and tolerance of these two alternative treatments in patients who are intolerant to SMX/TMP. The type of treatment being studied has the advantages of wide applicability throughout the world (including developing countries) and low cost. An oral treatment is more accessible to patients than drugs given by injection or by inhalation.
NCT00000640 A Phase III Comparative Study of Dapsone / Trimethoprim and Clindamycin / Primaquine Versus Sulfamethoxazole / Trimethoprim in the Treatment of Mild-to-Moderate PCP in Patients With AIDS Completed Jacobus Pharmaceutical Phase 3 1969-12-31 To evaluate the effectiveness of two oral treatments for mild to moderate Pneumocystis carinii pneumonia (PCP): dapsone/trimethoprim or clindamycin/primaquine as compared to a standard treatment program of sulfamethoxazole/trimethoprim (SMX/TMP) to assess the tolerance of these two alternative treatments as compared to the standard treatment of SMX/TMP. Per 09/09/92 amendment, to assess the efficacy and tolerance of these two alternative treatments in patients who are intolerant to SMX/TMP. The type of treatment being studied has the advantages of wide applicability throughout the world (including developing countries) and low cost. An oral treatment is more accessible to patients than drugs given by injection or by inhalation.
NCT00000640 A Phase III Comparative Study of Dapsone / Trimethoprim and Clindamycin / Primaquine Versus Sulfamethoxazole / Trimethoprim in the Treatment of Mild-to-Moderate PCP in Patients With AIDS Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 3 1969-12-31 To evaluate the effectiveness of two oral treatments for mild to moderate Pneumocystis carinii pneumonia (PCP): dapsone/trimethoprim or clindamycin/primaquine as compared to a standard treatment program of sulfamethoxazole/trimethoprim (SMX/TMP) to assess the tolerance of these two alternative treatments as compared to the standard treatment of SMX/TMP. Per 09/09/92 amendment, to assess the efficacy and tolerance of these two alternative treatments in patients who are intolerant to SMX/TMP. The type of treatment being studied has the advantages of wide applicability throughout the world (including developing countries) and low cost. An oral treatment is more accessible to patients than drugs given by injection or by inhalation.
NCT00000666 A Randomized Prospective Study of Pyrimethamine Therapy for Prevention of Toxoplasmic Encephalitis in HIV-Infected Individuals With Serologic Evidence of Latent Toxoplasma Gondii Infection Completed National Institute of Allergy and Infectious Diseases (NIAID) N/A 1969-12-31 To evaluate pyrimethamine as a prophylactic agent against toxoplasmic encephalitis in individuals who are coinfected with HIV and latent Toxoplasma gondii. Toxoplasmic encephalitis is a major cause of illness and death in AIDS patients. Standard treatment for toxoplasmic encephalitis is to combine pyrimethamine and sulfadiazine. Continuous treatment is necessary to prevent recurrence of the disease, but constant use of pyrimethamine/sulfadiazine is associated with toxicity. Clindamycin has been shown to be effective in treatment of toxoplasmic encephalitis in animal studies. This study evaluates pyrimethamine as a preventive treatment against toxoplasmic encephalitis (per 3/26/91 amendment, clindamycin arm was discontinued).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Clindamycin Hydrochloride

Condition Name

Condition Name for Clindamycin Hydrochloride
Intervention Trials
Acne Vulgaris 48
Malaria 10
Bacterial Vaginosis 7
HIV Infections 5
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Condition MeSH

Condition MeSH for Clindamycin Hydrochloride
Intervention Trials
Acne Vulgaris 50
Infection 25
Communicable Diseases 19
Malaria 12
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Clinical Trial Locations for Clindamycin Hydrochloride

Trials by Country

Trials by Country for Clindamycin Hydrochloride
Location Trials
United States 287
India 24
Canada 20
Germany 14
China 12
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Trials by US State

Trials by US State for Clindamycin Hydrochloride
Location Trials
California 28
New York 19
Pennsylvania 16
Florida 15
Texas 14
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Clinical Trial Progress for Clindamycin Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Clindamycin Hydrochloride
Clinical Trial Phase Trials
Phase 4 52
Phase 3 42
Phase 2/Phase 3 7
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Clinical Trial Status

Clinical Trial Status for Clindamycin Hydrochloride
Clinical Trial Phase Trials
Completed 90
Recruiting 42
Not yet recruiting 18
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Clinical Trial Sponsors for Clindamycin Hydrochloride

Sponsor Name

Sponsor Name for Clindamycin Hydrochloride
Sponsor Trials
GlaxoSmithKline 20
Stiefel, a GSK Company 12
National Institute of Allergy and Infectious Diseases (NIAID) 7
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Sponsor Type

Sponsor Type for Clindamycin Hydrochloride
Sponsor Trials
Other 207
Industry 100
NIH 11
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