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Last Updated: October 21, 2020

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CLINICAL TRIALS PROFILE FOR COPPER

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505(b)(2) Clinical Trials for Copper

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
OTC NCT02519231 Copper IUD Treatment Observation Study Recruiting Cook County Hospital Phase 4 2016-02-01 Studies indicate that bleeding irregularities and dysmenorrhea are common reasons for copper IUD method discontinuation. Some evidence suggests that non-steroidal anti-inflammatory medications (NSAIDs) can help improve bleeding during Cu-IUD use. However, these studies did not examine NSAID use with the TCu380A specifically, nor did they evaluate readily available NSAIDs such as over-the-counter naproxen. For this reason, the investigators propose a pilot trial in which new TCu380A users complaining of heavy or prolonged menstrual bleeding or spotting after 1 month of use are randomized to naproxen or placebo to be taken the first 7 days of menstruation for three consecutive cycles, and then observed for one cycle without treatment.
OTC NCT02519231 Copper IUD Treatment Observation Study Recruiting Teva Pharmaceuticals USA Phase 4 2016-02-01 Studies indicate that bleeding irregularities and dysmenorrhea are common reasons for copper IUD method discontinuation. Some evidence suggests that non-steroidal anti-inflammatory medications (NSAIDs) can help improve bleeding during Cu-IUD use. However, these studies did not examine NSAID use with the TCu380A specifically, nor did they evaluate readily available NSAIDs such as over-the-counter naproxen. For this reason, the investigators propose a pilot trial in which new TCu380A users complaining of heavy or prolonged menstrual bleeding or spotting after 1 month of use are randomized to naproxen or placebo to be taken the first 7 days of menstruation for three consecutive cycles, and then observed for one cycle without treatment.
OTC NCT02519231 Copper IUD Treatment Observation Study Recruiting University of Washington Phase 4 2016-02-01 Studies indicate that bleeding irregularities and dysmenorrhea are common reasons for copper IUD method discontinuation. Some evidence suggests that non-steroidal anti-inflammatory medications (NSAIDs) can help improve bleeding during Cu-IUD use. However, these studies did not examine NSAID use with the TCu380A specifically, nor did they evaluate readily available NSAIDs such as over-the-counter naproxen. For this reason, the investigators propose a pilot trial in which new TCu380A users complaining of heavy or prolonged menstrual bleeding or spotting after 1 month of use are randomized to naproxen or placebo to be taken the first 7 days of menstruation for three consecutive cycles, and then observed for one cycle without treatment.
New Formulation NCT04039828 Zinc Sulfate Acceptability Not yet recruiting International Centre for Diarrhoeal Disease Research, Bangladesh N/A 2019-07-01 Introduction: Zinc (Zn) is an essential mineral widely distributed within the human body with metalloproteins, Zinc-binding proteins, etc. It is necessary for signal transduction and also cell growth and proliferation via respective metallo- and zinc-dependent enzymes. Zinc supplementation can significantly reduce diarrheal severity and duration as well as prevents future incidences and reduces use of other medications in diarrhoea. For this reason WHO, UNICEF, USAID and experts worldwide jointly recommended zinc supplementation (10 mg for infants less than 6 months old and 20 mg in 6 - 59 months old) combined with reduced osmolarity ORS for clinical management of acute diarrhoea. But due to strong metallic taste zinc products are less palatable to children even after using masking flavours as recommended by WHO. Several companies have formulated the product since WHO recommendations came but still transient side effects like vomiting and regurgitation remain evident. Despite careful counselling to the caregivers expected adherence rate to 10 days regimen of zinc supplement is yet to be reached. With the aim to increase zinc supplement coverage during acute diarrheal illness, it is necessary to conduct a study to introduce new formulation Zinc tablet which is more palatable, more dispersible and more acceptable. Intervention: Zinc sulfate [Zinc Dispersible Tablet, 20 mg; (Elemental Zinc 20 mg as Zinc Sulfate Monohydrate / Tablet)] Methods: Prospective, open label, interventional study Hypothesis: Improved formulation of Zinc Sulfate will have good acceptability. Study population: Stratum 1: 3 months - <18 months = 175 children Stratum 2: 18 months - 59 months = 175 children Objectives: 1. Primary Objective: Acceptability of the zinc product in the management of childhood diarrhea will be assessed by observing: i) Incidence of vomiting or regurgitation among enrolled children receiving the improvised zinc formulation. ii) The adherence: The number of days (out of the total 10 days) the child took the protocol-prescribed dose of the medicine. The treatment will be considered to have good acceptability if at least 80% of the prescribed treatment is taken by at least 70% of the children over the duration of 10 days, as per WHO guidelines. 2. Secondary objective : To assess palatability Secondary end point evaluation (Palatability): The statistical analysis will comprise the calculation of the percentage of patients out of 350 who found the investigational product to have "very well-tolerated, well-tolerated or tolerated" scores (i.e. any of the upper 3 possible scores). A 95% confidence interval, using the normal approximation of the binomial distribution, will be calculated for the percentage.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Copper

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00001262 Copper Histidine Therapy for Menkes Diseases Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 1/Phase 2 1990-06-01 Menkes Disease is a genetic disorder affecting the metabolism of copper. Patient with this disease are both physically and mentally retarded. Menkes disease is usually first detected in the first 2-3 months of life. Infant males born with the disease fail to thrive, experience hypothermia, have delayed development, and experience seizures. These infants also have characteristic physical features such as changes of their hair and face. Females may also have changes in hair and skin color, but rarely have significant medical problems. Appropriate treatment of Menkes Disease requires that the disease be diagnosed early and treatment started before irreversible brain damage occurs. The aim of treatment is to bypass the normal route of absorption of copper through the gastrointestinal tract. Copper must then be delivered to brain cells and be available for use by enzymes. Copper histidine is a copper replacement that can be injected directly into the body to avoid absorption through the gastrointestinal tract. However, studies have shown the genetic abnormalities causing Menkes disease cannot simply be corrected by copper replacement injections. The genetic abnormality causing Menkes disease can vary in its severity. Patients with a genetic abnormality that may still permit some production of the enzymes required to process copper may receive benefit from early treatment with copper replacement. However, patients with severe abnormalities of the genes responsible for copper metabolism may receive no benefit from copper replacement. The purpose of this study is to continue to evaluate the effects of early copper histidine in Menkes disease patients and to correlate specific molecular defects with responses to treatment.
NCT00003751 Penicillamine, Low Copper Diet, and Radiation Therapy in Treating Patients With Glioblastoma Completed National Cancer Institute (NCI) Phase 2 1999-03-01 RATIONALE: Penicillamine may stop the growth of glioblastomas by stopping blood flow to the tumor. A diet low in copper may interfere with the growth of brain tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining these therapies may be effective in treating glioblastoma. PURPOSE: Phase II trial to study the effectiveness of penicillamine, a low copper diet, and radiation therapy in treating patients who have newly diagnosed glioblastoma.
NCT00003751 Penicillamine, Low Copper Diet, and Radiation Therapy in Treating Patients With Glioblastoma Completed Sidney Kimmel Comprehensive Cancer Center Phase 2 1999-03-01 RATIONALE: Penicillamine may stop the growth of glioblastomas by stopping blood flow to the tumor. A diet low in copper may interfere with the growth of brain tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining these therapies may be effective in treating glioblastoma. PURPOSE: Phase II trial to study the effectiveness of penicillamine, a low copper diet, and radiation therapy in treating patients who have newly diagnosed glioblastoma.
NCT00004338 Study of Zinc for Wilson Disease Completed University of Michigan Phase 4 1993-10-01 OBJECTIVES: I. Establish the safety and efficacy of extended maintenance zinc therapy in 200 patients with Wilson disease. II. Establish further the role of zinc in the prophylactic treatment of presymptomatic patients by increasing the current cohort from 80 to at least 100 patients. III. Establish further the role of zinc therapy in pregnant patients with Wilson disease. IV. Establish further the role of zinc therapy in children with Wilson disease.
NCT00004338 Study of Zinc for Wilson Disease Completed National Center for Research Resources (NCRR) Phase 4 1993-10-01 OBJECTIVES: I. Establish the safety and efficacy of extended maintenance zinc therapy in 200 patients with Wilson disease. II. Establish further the role of zinc in the prophylactic treatment of presymptomatic patients by increasing the current cohort from 80 to at least 100 patients. III. Establish further the role of zinc therapy in pregnant patients with Wilson disease. IV. Establish further the role of zinc therapy in children with Wilson disease.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Copper

Condition Name

Condition Name for Copper
Intervention Trials
Contraception 18
HIV 5
Wilson Disease 5
Pregnancy 4
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Condition MeSH

Condition MeSH for Copper
Intervention Trials
Hepatolenticular Degeneration 6
Glioblastoma 5
Breast Neoplasms 5
Diabetes Mellitus 4
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Clinical Trial Locations for Copper

Trials by Country

Trials by Country for Copper
Location Trials
United States 156
Egypt 8
Spain 5
India 5
Germany 4
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Trials by US State

Trials by US State for Copper
Location Trials
Michigan 15
New York 13
California 13
Pennsylvania 13
Texas 10
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Clinical Trial Progress for Copper

Clinical Trial Phase

Clinical Trial Phase for Copper
Clinical Trial Phase Trials
Phase 4 15
Phase 3 15
Phase 2/Phase 3 6
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Clinical Trial Status

Clinical Trial Status for Copper
Clinical Trial Phase Trials
Completed 54
Recruiting 29
Not yet recruiting 23
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Clinical Trial Sponsors for Copper

Sponsor Name

Sponsor Name for Copper
Sponsor Trials
University of Utah 7
Assiut University 5
National Cancer Institute (NCI) 5
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Sponsor Type

Sponsor Type for Copper
Sponsor Trials
Other 158
NIH 28
Industry 25
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