CLINICAL TRIALS PROFILE FOR POLYETHYLENE GLYCOL 3350
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505(b)(2) Clinical Trials for POLYETHYLENE GLYCOL 3350
| Trial Type | Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|---|
| OTC | NCT00681265 ↗ | Tear Film Break-up Time After Instillation of Artificial Tears | Completed | Eyeon Therapeutics, Inc. | N/A | 2008-06-01 | This study is an exploratory trial evaluating the tear film break-up time after a single eye drop instillation of over-the-counter artificial tears. The primary hypothesis is that tear film break up time will be greater for test than control eye. |
| OTC | NCT01044212 ↗ | Bowel Function After Minimally Invasive Urogynecologic Surgery | Completed | University of Rochester | N/A | 2009-11-01 | The purpose of this study is to assess the effect of a standardized postoperative bowel regimen of over-the-counter medications in subjects undergoing minimally invasive urogynecologic surgery. |
| New Formulation | NCT01325896 ↗ | Maintenance Treatment of Multiple Myeloma (MM) After Autologous Peripheral Blood Transplant (PBSCT) Using Polyethylene Glycol alpha2B Interpheron (PEG-INTRON) | Unknown status | Haematology Service, | Phase 2 | 2002-09-01 | - Multiple myeloma accounts for approximately 1% of all cancers and 10% of hematologic malignancies. Between 50 and 70% of symptomatic patients presented response to induction chemotherapy. The rate of complete responses (CR) achieved with standard induction of these treatments is less than 5% of cases and the median event-free survival between 2 and 3 years although most of the patients died from the disease. - High dose chemotherapy with autologous stem cell transplant has improved the response rate and survival of patient with MM. However eventually all patients relapse with a median EFS between 40-50 months post-transplant. - To improve these results and sustain remission, various maintenance treatment have been proposed as is the case of Interpheron alpha2b s.c. (Intron A) that has shown benefits in a meta-analysis. - Intron A s.c. need administration of 3 days per week and is not well tolerated - Recently a new formulation of Interpheron alpha2b is available. Conjugated with polietilenglicol (Pegintron) that need only one dose weekly and has not been tested in MM. - The purpose of this study is to evaluate the role of Pegintron as maintenance after autologous transplant in MM |
| New Formulation | NCT01325896 ↗ | Maintenance Treatment of Multiple Myeloma (MM) After Autologous Peripheral Blood Transplant (PBSCT) Using Polyethylene Glycol alpha2B Interpheron (PEG-INTRON) | Unknown status | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | Phase 2 | 2002-09-01 | - Multiple myeloma accounts for approximately 1% of all cancers and 10% of hematologic malignancies. Between 50 and 70% of symptomatic patients presented response to induction chemotherapy. The rate of complete responses (CR) achieved with standard induction of these treatments is less than 5% of cases and the median event-free survival between 2 and 3 years although most of the patients died from the disease. - High dose chemotherapy with autologous stem cell transplant has improved the response rate and survival of patient with MM. However eventually all patients relapse with a median EFS between 40-50 months post-transplant. - To improve these results and sustain remission, various maintenance treatment have been proposed as is the case of Interpheron alpha2b s.c. (Intron A) that has shown benefits in a meta-analysis. - Intron A s.c. need administration of 3 days per week and is not well tolerated - Recently a new formulation of Interpheron alpha2b is available. Conjugated with polietilenglicol (Pegintron) that need only one dose weekly and has not been tested in MM. - The purpose of this study is to evaluate the role of Pegintron as maintenance after autologous transplant in MM |
| New Dosage | NCT01533090 ↗ | Evaluation of Reduced-volume PEG Bowel Preparation Administered the Same Day of Colonoscopy | Completed | Catholic University of the Sacred Heart | N/A | 2010-04-01 | The conventional total dose of 4 L of polyethylene glycol (PEG) given the day before the procedure is safe and effective. It has been the standard cleansing regimen for the last 25 years. To overcome the difficulty in completing the bowel preparation due to large volume and/or taste, reduced-volume (mixed) bowel preparation of bisacodyl and 2 L of PEG have been shown to provide adequate colon cleansing and better tolerability. LoVol-esse is a reduced-volume PEG-based bowel preparation to be used in combination with bisacodyl and designed to improve patient tolerability and attitude toward bowel cleansing prior to colonoscopy thanks to the reduced volume and improved taste. The present study is intended to compare the new dosing regimen of the bowel lavage solution given the same day compared with standard PEG formulation (SELG 1000) given the day before colonoscopy. |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for POLYETHYLENE GLYCOL 3350
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00001410 ↗ | PEG-Glucocerebrosidase for the Treatment of Gaucher Disease | Completed | National Institute of Mental Health (NIMH) | Phase 1 | 1993-10-01 | Gaucher disease is a lysosomal storage disease resulting from glucocerebroside accumulation in macrophages due to a genetic deficiency of the enzyme glucocerebrosidase. It may occur in patients of all ages. The condition is marked by enlargement of the liver and spleen (hepatosplenomegaly), low blood and platelet counts, and bone abnormalities. The condition is passed from generation to generation on via autosomal recessive inheritance. There are actually three types of Gaucher disease. Type I is the most common form. It is a chronic non-neuronopathic form, meaning the disease does not affect the nervous system. The symptoms of type I can appear at any age. Type 2 Gaucher disease presents prenatally or in infancy and usually results in death for the patient. Type 2 is an acute neuronopathic form and can affect the brain stem. It is the most severe form of the disease. Type 3 Gaucher disease is also neuronopathic, however it is subacute in nature. This means the course of the illness lies somewhere between long-term (chronic) and short-term (acute). Currently there is not a cure for Gaucher disease. Treatment for the disease has traditionally been supportive. In some severely affected patients, bone-marrow transplants have corrected the enzyme deficiency, but it is considered a high-risk procedure and recovery can be very slow. Enzyme replacement therapy is another therapy option and has been approved by the Food and Drug Administration (FDA) for use in type 1 patients. PEG-glucocerbrosidase is a drug designed to clear out the accumulation of lipid (glucocerebroside) from the blood stream. The drug is actually an enzyme attached to large molecules called polyethylene glycol (PEG). The large molecules of PEG allow the enzyme to remain in the blood stream for long periods of time. By modifying glucocerebrosidase with PEG, it is believed that smaller doses will be required, meaning a reduction in cost for the patient and more convenient administration of the drug. The purpose of this study is to evaluate the effects and safety of enzyme replacement therapy using PEG- glucocerebrosidase for the treatment of Gaucher disease. |
| NCT00004695 ↗ | Randomized Study of Polyethylene-Glycol-Conjugated Interleukin 2 in Patients With Common Variable Immunodeficiency | Completed | Icahn School of Medicine at Mount Sinai | N/A | 1997-09-01 | OBJECTIVES: I. Determine whether polyethylene-glycol-conjugated interleukin 2 (PEG-IL-2) can reduce the number of infections in patients with common variable immunodeficiency. II. Determine whether this therapy can improve lung functions in these patients with pulmonary impairment. |
| NCT00018031 ↗ | Peginterferon Alpha-2b And Ribavirin to Treat Hepatitis C in HIV-Infected Patients | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | Phase 2 | 2001-06-01 | This study will evaluate the safety and effectiveness of combination therapy with peginterferon alfa-2b and ribavirin for treating hepatitis C virus (HCV) infection in HIV-infected patients. In studies of patients with hepatitis C alone, interferon alfa-2b plus ribavirin treatment eradicated the HCV in almost half the patients. Peginterferon alfa-2b is a compound that results from attaching a polyethylene glycol molecule to interferon alfa-2b. This compound stays in the blood longer than unmodified interferon alfa-2b, causing a higher blood concentration and thus maintaining activity against the hepatitis C virus. HIV-infected patients 21 years of age and older with chronic hepatitis C infection and a viral load greater than 2000 copies/mL may be eligible for this 2 1/2-year study. Candidates will be screened with blood and urine tests and possibly a liver biopsy, if a recent one is not available. The liver biopsy is done to determine the severity of liver disease. For this test, patients are admitted to the NIH Clinical Center for 1 to 2 days. A sedative is injected into an arm vein, the skin in the area over the biopsy site is numbed with a local anesthetic, and a needle is inserted rapidly into and out of the liver to obtain a small tissue sample. The patient remains in the hospital overnight for monitoring. A chest X-ray, electrocardiogram (EKG) and liver ultrasound are also done. Within 4 weeks of the screening tests, candidates who appear eligible for the study will have a physical examination, medical history and repeat blood tests. Women who can become pregnant will have serial pregnancy tests throughout the study. Patients who meet the study criteria and decide to participate will begin treatment with weekly injections under the skin of peginterferon alfa-2b and take ribavirin pills twice a day by mouth. In addition, patients will continue to take all other medications prescribed by their doctor. Clinic visits will be scheduled as follows: - Days 1, 3, 5, 7, 10 and 21 - Blood will be drawn for safety tests and to measure blood levels of HIV and HCV. - Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 52, 56 and 64 - Blood and urine tests will be done to determine the side effects of treatment and its effect on the HCV infection. - Week 48 or end of treatment - Treatment will stop after 48 weeks. At this time, or earlier for those who do not complete the 48 weeks, patients will return to the clinic for a routine test. |
| NCT00029900 ↗ | ADI-PEG in Patients With Metastatic Melanoma | Completed | FDA Office of Orphan Products Development | Phase 1 | 2001-09-01 | This is a study to determine the safety and toxicity of increasing doses of arginine deiminase combined to polyethylene glycol (ADI-PEG) in patients with nonresectable metastatic melanoma. |
| NCT00056992 ↗ | Testing of ADI-PEG in Hepatocellular Carcinoma | Completed | FDA Office of Orphan Products Development | Phase 2 | 2002-09-01 | Amino acid deprivation therapy is an effective means for the treatment of some forms of cancer. Recently it has been found that human hepatocellular carcinomas (HCC) cell lines appear to require arginine for growth. Arginine is not an essential amino acid for human adults or infants as it can be synthesized from citrulline (for review see Rogers 1994). Therefore, selective elimination of arginine from the circulation may be a means of treating patients with metastatic melanoma or non resectable HCC. The enzyme arginine deiminase (ADI) metabolizes arginine into citrulline (Cunin 1986). However, ADI is only found in microbes and not in humans. ADI is therefore, highly immunogenic and has a short serum half-life following injection. These potential drawbacks (microbial source and thus viewed as foreign by the human immune system, and a short serum half-life) can be overcome by covalent attachment of polyethylene glycol (PEG) to argininedeiminase and termed this drug ADI-PEG 20. ADI-PEG 20 appears to be an effective anti-cancer treatment for human HCC. Pharmacokinetic and pharmacodynamic data indicates a once a week injection of 160 IU/m2 of ADI-PEG 20 eliminates all detectable arginine from the circulation for at least 7 days. This treatment appears to be well tolerated. The purpose of this study is to determine the efficacy of this treatment in patients with HCC. Efficacy is a primary end point of this study. No patients will recieve placebo. |
| NCT00085917 ↗ | Peginterferon Alpha-2a and Ribavirin to Treat Hepatitis C in HIV-infected Patients | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | Phase 2 | 2004-06-01 | This study will evaluate the safety and effectiveness of combination therapy with peginterferon alpha-2a and ribavirin for treating hepatitis C virus (HCV) infection in HIV-infected patients. Peginterferon alpha with ribavirin is the therapy of choice for people with HCV alone. Peginterferon alpha-2a is a compound that results from attaching a polyethylene glycol molecule to interferon alpha-2a. This compound stays in the blood longer than unmodified interferon alpha-2a, causing a higher blood concentration and thus maintaining greater activity against the hepatitis C virus. HIV-infected patients 18 years of age and older with chronic hepatitis C infection and a viral load greater than 2000 copies/mL may be eligible for this 2-1/2 year study. Candidates are screened with a medical history and physical examination, blood and urine tests, eye examination, chest x-ray, electrocardiogram (EKG), liver ultrasound, and pregnancy test in women who are able to become pregnant. If a recent liver biopsy is not available, this test is done to determine the type and severity of liver disease. The patient is given a sedative before the procedure. Then, the skin in the area over the biopsy site is numbed with a local anesthetic and a needle is inserted rapidly into and out of the liver to obtain a small tissue sample. The patient remains in the hospital overnight for monitoring. Participants begin treatment with injections under the skin of peginterferon alpha-2a and ribavirin pills by mouth on study day 0. Peginterferon is given either once or twice a week for 4 weeks and then once a week for 44 weeks. Ribavirin is given daily. In addition, patients continue to take all other medications prescribed by their doctor. Clinic visits are scheduled for the following procedures: - Days 1, 3, 4, 7, 10 and weeks 2, 3, and 4 - Blood tests for safety measures and to measure blood levels of HIV and HCV. - Weeks 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 - Blood and urine tests to determine the side effects of treatment and its effect on the HCV infection. In addition, eye examinations are done every 3 months, and pregnancy and thyroid function tests are done several times during the treatment period. - Week 48 or end of treatment - Treatment stops after 48 weeks. At this time, or earlier for those who do not complete the 48 weeks, patients return to the clinic for a chest x-ray, EKG, blood tests, and abdominal ultrasound. Patients are hospitalized for a repeat liver biopsy. - Weeks 52, 56, 64 and 72 - Blood and urine tests to determine the side effects of treatment and its effect on the HCV infection, and a urine pregnancy test in women. |
| NCT00090753 ↗ | A Study of Intravenous or Subcutaneous Methoxy Polyethylene Glycol-Epoetin Beta (RO0503821, Mircera) in Chronic Kidney Disease Patients With Renal Anemia | Completed | Hoffmann-La Roche | Phase 3 | 2004-10-01 | This study assessed the long-term efficacy, safety, and tolerability of intravenous (iv) or subcutaneous (sc) methoxy polyethylene glycol-epoetin beta in chronic kidney disease patients with renal anemia. Eligible patients were those who were receiving stable maintenance therapy with methoxy polyethylene glycol-epoetin beta or erythropoiesis stimulating agents (ESAs) in Phase II or III clinical studies. They continued to receive methoxy polyethylene glycol-epoetin beta or comparator ESAs at the same weekly dose and by the same route of administration (sc or iv) as in the qualifying studies. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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