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Generated: February 22, 2019

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CLINICAL TRIALS PROFILE FOR DAPSONE

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Clinical Trials for Dapsone

Trial ID Title Status Sponsor Phase Summary
NCT00000596 Diffuse Fibrotic Lung Disease Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 2 To determine the effects of cyclophosphamide compared with prednisone, dapsone, or high-dose intermittent 'pulse' therapy with methylprednisolone in patients with idiopathic pulmonary fibrosis. Also, to evaluate the use of intermittent, short-term, high-dose intravenous corticosteroids in patients with sarcoidosis. There were actually four separate clinical trials.
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 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 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 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 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).
NCT00000739 Comparison of Two Dosage Regimens of Oral Dapsone for Prophylaxis of Pneumocystis Carinii Pneumonia in Pediatric HIV Infection Completed Jacobus Pharmaceutical Phase 1 Primary: To compare the toxicity of daily versus weekly dapsone in HIV-infected infants and children; to study the pharmacokinetics of orally administered dapsone in HIV-infected infants and children. Secondary: To obtain information on the rate of Pneumocystis carinii pneumonia ( PCP ) breakthrough in children receiving two different dose regimens of dapsone. Prophylaxis for Pneumocystis carinii pneumonia ( PCP ) is recommended for all HIV-infected children considered to be at high risk. Approximately 15 percent of children are intolerant to trimethoprim / sulfamethoxazole, the first choice drug for PCP prophylaxis. Since many children are also unable to take or tolerate aerosolized pentamidine, dapsone is a second choice for PCP prophylaxis. The most favorable dose regimen for dapsone has not been established.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Dapsone

Condition Name

Condition Name for Dapsone
Intervention Trials
Acne Vulgaris 17
Malaria 13
HIV Infections 11
Pneumonia, Pneumocystis Carinii 8
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Condition MeSH

Condition MeSH for Dapsone
Intervention Trials
Acne Vulgaris 19
Malaria 17
HIV Infections 11
Pneumonia, Pneumocystis 9
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Clinical Trial Locations for Dapsone

Trials by Country

Trials by Country for Dapsone
Location Trials
United States 225
Malawi 8
Tanzania 7
France 4
Germany 4
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Trials by US State

Trials by US State for Dapsone
Location Trials
California 21
New York 14
Pennsylvania 12
Ohio 11
North Carolina 11
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Clinical Trial Progress for Dapsone

Clinical Trial Phase

Clinical Trial Phase for Dapsone
Clinical Trial Phase Trials
Phase 4 17
Phase 3 23
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Dapsone
Clinical Trial Phase Trials
Completed 54
Recruiting 6
Terminated 5
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Clinical Trial Sponsors for Dapsone

Sponsor Name

Sponsor Name for Dapsone
Sponsor Trials
Allergan 16
National Institute of Allergy and Infectious Diseases (NIAID) 9
Jacobus Pharmaceutical 7
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Sponsor Type

Sponsor Type for Dapsone
Sponsor Trials
Other 97
Industry 47
NIH 15
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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Healthtrust
UBS
Julphar
Daiichi Sankyo
McKesson
Moodys
Chinese Patent Office
Johnson and Johnson

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