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Last Updated: January 18, 2021

DrugPatentWatch Database Preview

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.
>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 49
Malaria 10
Bacterial Vaginosis 7
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Condition MeSH

Condition MeSH for Clindamycin Hydrochloride
Intervention Trials
Acne Vulgaris 51
Infection 28
Communicable Diseases 22
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Clinical Trial Locations for Clindamycin Hydrochloride

Trials by Country

Trials by Country for Clindamycin Hydrochloride
Location Trials
United States 290
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 21
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 58
Phase 3 43
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 45
Not yet recruiting 26
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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 218
Industry 101
NIH 12
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