You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 11, 2024

CLINICAL TRIALS PROFILE FOR CLINDAMYCIN HYDROCHLORIDE


✉ Email this page to a colleague

« Back to Dashboard


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 2014-02-21 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 Completed 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 Completed Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. 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 53
Bacterial Vaginosis 10
Malaria 10
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Clindamycin Hydrochloride
Intervention Trials
Acne Vulgaris 57
Infections 36
Infection 32
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Clindamycin Hydrochloride

Trials by Country

Trials by Country for Clindamycin Hydrochloride
Location Trials
United States 342
Canada 27
India 25
Germany 15
China 13
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Clindamycin Hydrochloride
Location Trials
California 30
New York 22
Pennsylvania 18
Texas 18
Florida 17
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Clindamycin Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Clindamycin Hydrochloride
Clinical Trial Phase Trials
Phase 4 75
Phase 3 47
Phase 2/Phase 3 7
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Clindamycin Hydrochloride
Clinical Trial Phase Trials
Completed 132
Unknown status 32
Recruiting 28
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Clindamycin Hydrochloride

Sponsor Name

Sponsor Name for Clindamycin Hydrochloride
Sponsor Trials
GlaxoSmithKline 22
Stiefel, a GSK Company 14
National Institute of Allergy and Infectious Diseases (NIAID) 7
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Clindamycin Hydrochloride
Sponsor Trials
Other 310
Industry 123
NIH 12
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.