CLINICAL TRIALS PROFILE FOR COLD CAPSULE V
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505(b)(2) Clinical Trials for COLD CAPSULE V
| Trial Type | Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|---|
| OTC | NCT00009542 ↗ | Effects of Kava on the Body's Elimination of Caffeine and Dextromethorphan | Completed | National Institutes of Health Clinical Center (CC) | Phase 4 | 2001-01-01 | This study will examine how kava-a widely used herbal remedy-may affect the body's elimination of other medicines. Many people take kava to reduce anxiety or cause sedation. Since this product is considered a food supplement and not a drug, it is not subject to the rigorous pre-market testing required for prescription and over-the-counter (OTC) drugs. As a result, information has not been collected on possible interactions between kava and other medications. This study will look at how kava affects the elimination of caffeine-a compound commonly found in chocolate, coffee, tea and soft drinks-and dextromethorphan-an OTC cough suppressant. Normal healthy volunteers 21 years of age or older may be eligible for this 30-day study. Candidates will provide a medical history and undergo a physical examination and routine blood tests. Women of childbearing age will have a urine pregnancy test. Study participants will not drink alcoholic beverages or take any medications (except those given in the study) for 2 weeks prior to the study and throughout its duration. In addition, they will abstain from caffeine, grapefruit and grapefruit juice and charbroiled foods for at least 72 hours before and throughout each study day that urine is collected. On day 1 of the study, study subjects will take one dose each of caffeine and dextromethorphan at 4:00 P.M.. They will empty their bladder before the dosing and then collect all their urine after the dosing for the rest of the day and including the next mornings first urine. They will bring the urine samples to the Clinical Center when the collection is complete. This procedure will be repeated 1 week later (study day 8). After the second urine collection is completed, subjects will take 200 milligrams of kava 3 times a day for 21 days. On study day 29 (after 21 days of kava), subjects will repeat the dextromethorphan and caffeine dosing and urine collection described above, while continuing to take kava. Subjects will have an electroencephalograph (EEG) done before starting kava and again at the end of kava (study day 30). For this procedure, several electrodes (metal cups attached to wires) are secured to the scalp with a glue-like substance. A conductive gel fills the space between the electrode and the scalp to ensure good contact. The electrodes will remain in place for about 2 hours and then removed. The subject lies quietly on a bed during the EEG recording. Participation in the study will end with another physical examination and blood tests following the second EEG and urine collection. |
| New Formulation | NCT00055263 ↗ | A New Formulation of Calcitriol (DN-101) in Patients With Advanced Malignancies | Completed | Novacea | Phase 1 | 2002-03-01 | The purposes of this study are to: - Test the safety of DN-101 in patients with advanced malignancies - Understand how fast the body absorbs, processes, and eliminates DN-101 - Determine the highest dose of DN-101 that is well tolerated by cancer patients - Learn how fast the body absorbs, processes, and eliminates DN-101 compared to the approved product |
| New Formulation | NCT00498745 ↗ | Study Comparing 2 New Formulations of HKI-272 in Healthy Adult Subjects | Completed | Puma Biotechnology, Inc. | Phase 1 | 2007-07-01 | To evaluate the comparative bioavailability of 2 new tablet formulations of HKI-272 with a reference capsule and an oral solution in healthy subjects. |
| New Formulation | NCT00499538 ↗ | Study Evaluating 3 New Formulations of SKI-606 in Healthy Adult Subjects | Completed | Wyeth is now a wholly owned subsidiary of Pfizer | Phase 1 | 2007-07-01 | To evaluate the comparative bioavailability of 3 new tablet formulations of SKI-606 with a reference capsule and an oral solution in healthy subjects. |
| New Combination | NCT00620828 ↗ | The Role of Intra-Operative Intracapsular Blocks in Post-Operative Pain Management Following Total Knee Arthroplasty | Completed | Pfizer | Phase 4 | 2007-05-01 | The purpose of this study is to use a new combination of anesthesia techniques in an attempt to minimize early pain after surgery and improve the patient's ability to participate more fully with physical therapy. Total knee replacement patients who participate will receive the standard anesthesia. This includes a spinal nerve block as well as a femoral nerve block. The study is looking at the added benefits of including an injection of numbing medication (Bupivicaine) to the back of the knee. This injection occurs during surgery. In order to compare the outcomes we will also have a group of patients who will receive a saline injection as opposed to the numbing medication. Patients are randomly assigned to a group. Outcomes are measured up until twenty-four hours following the surgery. |
| New Combination | NCT00620828 ↗ | The Role of Intra-Operative Intracapsular Blocks in Post-Operative Pain Management Following Total Knee Arthroplasty | Completed | Duke University | Phase 4 | 2007-05-01 | The purpose of this study is to use a new combination of anesthesia techniques in an attempt to minimize early pain after surgery and improve the patient's ability to participate more fully with physical therapy. Total knee replacement patients who participate will receive the standard anesthesia. This includes a spinal nerve block as well as a femoral nerve block. The study is looking at the added benefits of including an injection of numbing medication (Bupivicaine) to the back of the knee. This injection occurs during surgery. In order to compare the outcomes we will also have a group of patients who will receive a saline injection as opposed to the numbing medication. Patients are randomly assigned to a group. Outcomes are measured up until twenty-four hours following the surgery. |
| New Formulation | NCT01052883 ↗ | TMC114-TiDP3-C182 - A Study to Compare the Oral Bioavailability of a 800 mg Prototype Tablet Formulation of Darunivar (DRV) to That of the 400 mg Commercial Tablet Formulation in the Presence of Low Dose Ritonavir, Under Fasted and Fed Conditions | Completed | Tibotec Pharmaceuticals, Ireland | Phase 1 | 2010-03-01 | The purpose of this study is to compare the drug levels of darunavir obtained after administration of a single administration of the 800 mg tablet (new formulation) to that following administration of two 400 mg commercial tablets formulation when administered under fed and fasted conditions to those also taking low-dose ritonavir. Darunavir is marketed for the treatment of HIV. The short-term safety and tolerability of darunavir following administration of a single 800 mg dose of darunavir given to healthy volunteers taking taking low-dose ritonavir will also be assessed. |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for COLD CAPSULE V
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00000152 ↗ | Randomized Trial of Beta-Carotene and Macular Degeneration | Unknown status | National Eye Institute (NEI) | Phase 3 | 1982-04-01 | To determine whether 50 mg of beta-carotene taken every other day reduces the risk of developing age-related macular degeneration (AMD) among male U.S. physicians who were aged 40 to 84 in 1982. To investigate the possible relationship of AMD with other antioxidants, including selenium and vitamins A, C, and E. To identify potential risk factors for development of AMD. Possible risk factors include height, systemic hypertension, cardiovascular disease, blood cholesterol, cigarette smoking, iris and skin color, sunlight exposure, body mass index, diabetes, and alcohol intake. |
| NCT00000461 ↗ | Harvard Atherosclerosis Reversibility Project (HARP) | Completed | National Heart, Lung, and Blood Institute (NHLBI) | Phase 2 | 1986-12-01 | To determine by sequential coronary arteriography whether a lipid-lowering diet with and without lipid-lowering drugs could reverse coronary artery disease in normocholesterolemic patients. Also, to test whether fish oil supplements could improve human coronary atherosclerosis. Finally, to determine the effect of combination therapy with lipid-reducing drugs in patients with coronary heart disease and "normal" cholesterol levels. At least three clinical trials were conducted. |
| NCT00000500 ↗ | Physicians' Health Study | Completed | National Heart, Lung, and Blood Institute (NHLBI) | Phase 3 | 1981-09-01 | To assess the effect on cardiovascular mortality of alternate-day consumption of 325 milligrams of aspirin and, secondarily, the effect on cancer incidence of alternate-day consumption of 50 milligrams of beta-carotene. |
| NCT00000500 ↗ | Physicians' Health Study | Completed | Brigham and Women's Hospital | Phase 3 | 1981-09-01 | To assess the effect on cardiovascular mortality of alternate-day consumption of 325 milligrams of aspirin and, secondarily, the effect on cancer incidence of alternate-day consumption of 50 milligrams of beta-carotene. |
| NCT00000687 ↗ | Phase II Study of Zidovudine and Recombinant Alpha-2A Interferon in the Treatment of Patients With AIDS-Associated Kaposi's Sarcoma | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | Phase 2 | 1969-12-31 | To determine the safety and effectiveness of combining zidovudine (AZT) and interferon alfa-2a (IFN-A2a) in a treatment for Kaposi's sarcoma (KS) in patients who have AIDS. It is hoped with the present study to define the rate at which the treatment affects the tumors and also to assess any toxic effects of the combination treatment over a period of time. In a recent study, the combination of IFN-A2a and AZT in the treatment of patients with AIDS-associated KS was evaluated and safe doses of both AZT and IFN-A2a were determined. In addition, it appeared that there was a substantial reduction in KS lesions with this therapy. Potential benefits of this combined therapy include resolution of KS lesions, prolonged survival, a decrease in the frequency and severity of opportunistic infections, improvement in CD4 cells, and a decrease in serum p24 antigens. |
| NCT00000696 ↗ | A Phase I/II Open Label Study To Evaluate the Antiviral Potential of Combination Low-Dose Therapy With Zidovudine and Interferon-Alpha 2A in Patients With Symptomatic HIV Disease | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | Phase 1 | 1969-12-31 | To evaluate the anti-HIV effect of single agent versus combination therapy with zidovudine (AZT) and interferon alfa-2a (IFN-A2a), as measured by p24 protein expression, viral growth and infectivity in patients with symptomatic HIV disease. To assess the safety of low dose schedules of AZT and IFN-A2a, alone and in combination, as measured by neutrophil counts and hepatic transaminase levels. To evaluate the comparative effects of single agent versus combination therapy with AZT and IFN-A2a on CD4 cell counts and skin test reactivity. AZT is known to be an effective treatment for HIV infection. However, patients may develop reactions to AZT when it is administered for long periods of time. Combining AZT with another drug at lower doses might reduce toxicity in patients and prevent the development of drug resistant strains. IFN-A2a can reduce the growth of HIV in test tube experiments and recent studies have shown that when AZT and IFN-A2a are used together they reduce the growth of HIV more effectively than when either drug is used alone. This study will examine the effectiveness and safety of these drugs when they are given together and compare these results with the effectiveness and safety of the drugs when they are used alone. |
| NCT00000727 ↗ | A Controlled Comparative Trial of Sulfamethoxazole-Trimethoprim Versus Aerosolized Pentamidine for Secondary Prophylaxis of Pneumocystis Carinii Pneumonia in AIDS Patients Receiving Azidothymidine (AZT) | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | Phase 3 | 1969-12-31 | To determine if the drug combination sulfamethoxazole-trimethoprim (SMX-TMP), given by mouth, and the drug pentamidine (PEN), given by inhaled aerosol, are effective in preventing a relapse of Pneumocystis carinii pneumonia (PCP) when they are given to patients who have recovered from a first episode of PCP and are being given zidovudine (AZT) to treat primary HIV infection. AZT prolongs survival in patients with AIDS and decreases the occurrence of opportunistic infections such as PCP. However, PCP recurs in about 43 percent of patients receiving AZT, indicating a need for other treatments to reduce the relapse rate. The two medications to be tested in this study, SMX/TMP and aerosolized PEN, have also been partially effective in preventing recurrence of PCP. It is hoped that the combination of AZT with these medications will be more effective than AZT or one of the medications alone. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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