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Gabapentin to treat itch in patients with liver disease Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Gabapentin to treat itch in patients with liver disease conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Gabapentin to treat itch in patients with liver disease Clinical research trials and Gabapentin to treat itch in patients with liver disease health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Gabapentin to treat itch in patients with liver disease. Gabapentin to treat itch in patients with liver disease Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Gabapentin to treat itch in patients with liver disease clinical trial. Test subjects typically receive the most expert healthcare available for their Gabapentin to treat itch in patients with liver disease condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "G" Clinical Trials Conditions > Gabapentin to treat itch in patients with liver disease  Gabapentin to treat itch in patients with liver disease
Gabapentin to treat itch in patients with liver disease
For Condition: Cholestasis,Liver Disease,Cirrhosis,Pruritus,Itching
Status: No longer recruiting
Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ,
Synopsis: In this study, the effect of the medication gabapentin to treat itching secondary to liver disease is being studied. There are some funds to cover travel expenses for patients who are not from New York. Gabapentin is approved to treat seizures in human beings. In this study, patients with liver disease who meet inclusion criteria are admitted to the research hospital of the New York Presbyterian Hospital to record scratching behavior by the use of a machine designed for that purpose. Blood work will be obtained. After completion of recording, patients are assigned by chance to receive active medication or placebo (a capsule that does not contain active medication). The patients will come to the outpatient office of the research hospital 2 weeks into the study for an interview and blood work. After 4 weeks, patients are readmitted to the hospital to record scratching behavior. After data are collected, the code is broken, if patient had been on inactive drug, active drug will be supplied as per protocol for 4 weeks. Blood work will be obtained. If patient had been randomized to active medication, the study will provide one week supply of drug. After that, the referring physician, with whom the study was previously discussed, could prescribe the medication as it is available.
Details: Double-blind, randomized, placebo-controlled study of gabapentin for the pruritus of cholestasis. Duration: 4 weeks. Some travel funds available for patients from out of the NY area for all the visits. Hospitalization at baseline and after 4 weeks of treatment. One OPD visit at week 2. All patients have to be referred by their physician, who will receive a summary of the results at the end of the patient's study participation. If patients are randomized to active drug and respond to it with decrease in pruritus, a one week supply of medication is given. The referring physician could prescribe the drug for long term use. If the patient is randomized to placebo they can be treated with active medication provided by the study for 4 weeks, at end of which, the drug could be prescribed by referring physician if the patient responds to the drug with decrease in the pruritus.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/80 Years
Genders: Both
Protocol Entry Criteria: Inclusion criteria include: - Patients from ages 18 to 80 with chronic pruritus secondary to liver disease Patients must have: - a normal chest X- ray during the previous year - normal thyroid function tests (treated thyroid dysfunction is acceptable) - controlled diabetes, if diabetes mellitus is present - negative fecal occult blood within the previous year Exclusion criteria include: - history of hepatic encephalopathy - decompensated liver disease as suggested by ascites and history of variceal bleeding - malignancy - inability to practice contraception - pregnancy - creatinine > 1.7 mg/dl - hemoglobin < 10mg/dl - S/P liver transplantation - HIV infection
Total Enrollment: 30
Location and Contact Information:
Columbia University College of Physicians and Surgeons
New York City, New York, 10032
United States
Additional Information:
Study ID Numbers: 9618;
Study Start Date: November 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00058890
Other Cirrhosis Studies:
1. Gabapentin to treat itch in patients with liver disease
2. Study of Magnesium Sulfate in Children With Reduced Bone Density Secondary to Chronic Cholestatic Liver Disease
3. Randomized Study of Tauroursodeoxycholic Acid in Prophylactic Therapy of Total Parenteral Nutrition Associated Cholestasis in Infants
4. Sincalide (Cholecystokinin Octapeptide) versus Placebo in Neonates at High Risk for Developing Parenteral Nutrition Associated Cholestasis
5. Safety and Efficacy Study of a Caspase Inhibitor in Patients Undergoing Liver Transplantation
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Gabapentin to treat itch in patients with liver disease
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