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| Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
|---|---|
| Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| ClinicalTrials.gov Identifier: | NCT00058890 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Liver Disease Cholestasis Cirrhosis Pruritus Itching |
Drug: gabapentin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Study of Gabapentin for the Pruritus of Cholestasis |
| Estimated Enrollment: | 30 |
| Study Start Date: | November 2000 |
| Estimated Study Completion Date: | January 2004 |
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| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria include:
Patients must have:
Exclusion criteria include:
Contacts and Locations| United States, New York | |
| Columbia University College of Physicians and Surgeons | |
| New York, New York, United States, 10032 | |
| Principal Investigator: | Nora V Bergasa, M.D. | New York Presbyterian Hospital Columbia University College of Physicians and Surgeons |
More Information
| Study ID Numbers: | 9618 |
| Study First Received: | April 14, 2003 |
| Last Updated: | December 1, 2006 |
| ClinicalTrials.gov Identifier: | NCT00058890 |
| Health Authority: | United States: Federal Government |
|
itching pruritus cholestasis |
liver disease hepatitis cirrhosis |
|
Pruritus Excitatory Amino Acids Liver Diseases Skin Diseases Cholestasis Fibrosis Gabapentin |
Liver Cirrhosis Hepatitis Signs and Symptoms Calcium, Dietary Digestive System Diseases Bile Duct Diseases Biliary Tract Diseases |
|
Skin Manifestations Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Antiparkinson Agents Calcium Channel Blockers Excitatory Amino Acid Agents Cardiovascular Agents |
Antimanic Agents Pharmacologic Actions Membrane Transport Modulators Pathologic Processes Sensory System Agents Therapeutic Uses Anti-Anxiety Agents Analgesics Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants Excitatory Amino Acid Antagonists |
