Liver DiseasePhase 3NCT00058890
Gabapentin to Treat Itch in Patients With Liver Disease
A Phase 3 study testing Gabapentin in people with Liver Disease and Cholestasis, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
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 (NY). Gabapentin is approved to treat seizures in human beings. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Disease, Cholestasis, Cirrhosis
- What is being tested?
- Gabapentin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2000to Jan 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- hemoglobin < 10mg/dl
- S/P liver transplantation
- HIV infection
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University College of Physicians and Surgeons
New York, New York, 10032
About this study
Official title: Study of Gabapentin for the Pruritus of Cholestasis
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 (NY).
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.
Read the detailed description
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 outpatient department 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.
- Conditions
- Liver Disease, Cholestasis, Cirrhosis, Pruritus, Itching
- Being tested
- Gabapentin, Placebo
- Keywords
- itching, pruritus, cholestasis, liver disease, hepatitis, cirrhosis
- Medical subject headings
- Liver Diseases, Cholestasis, Fibrosis, Pruritus, Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Under code, the study drug was started at 100 mg by mouth 3 times a day for 3 days, to be increased, if necessary and in the absence of side effects, by 300 mg every 3 days to a maximum of 2,400 mg daily in divided doses.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin | Experimental | Not described Receives: Drug: Gabapentin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in scratching activity monitoring system
A scratching activity monitoring system specifically designed to record scratching behavior independent of gross body movement
Measured: 4 weeks
Secondary outcomes (1)
Change in visual analogue scale for pruritus
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2003 (estimated)
- Study startNov 2000
- Primary completionJan 2004
- Study completionJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver DiseaseStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Nora V Bergasa, M.D., Principal investigator, New York Presbyterian Hospital Columbia University College of Physicians and Surgeons
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00058890
- Sponsor's protocol ID
- R03 --9618 (completed 2005)
- Other IDs
- R03DK055618
- Status last verified
- Oct 2017
- First submitted
- 14 Apr 2003
- Last updated
- 13 Oct 2017
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Bergasa NV, McGee M, Ginsburg IH, Engler D. Gabapentin in patients with the pruritus of cholestasis: a double-blind, randomized, placebo-controlled trial. Hepatology. 2006 Nov;44(5):1317-23. doi: 10.1002/hep.21370.
PubMed 17058231
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Gabapentin for the Pruritus of Cholestasis
- ClinicalTrials.gov ID
- NCT00058890
- Acronym / sponsor ID
- R03 --9618 (completed 2005)
- Conditions
- Liver Disease, Cholestasis, Cirrhosis, Pruritus, Itching
- Keywords
- itching, pruritus, cholestasis, liver disease, hepatitis, cirrhosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Nov 2000 (actual)
- Primary completion
- Jan 2004 (actual)
- Study completion
- Jan 2004 (actual)
- First posted
- 16 Apr 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (NY).
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.
Detailed description
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 outpatient department 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gabapentin | Experimental | Drug: Gabapentin |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients from ages 18 to 80 with chronic pruritus secondary to liver disease
- 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
Key exclusion criteria (9 listed)
- history of hepatic encephalopathy
- decompensated liver disease as suggested by ascites and history of variceal bleeding
- malignancy
- inability to practice contraception
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GabapentinUnder code, the study drug was started at 100 mg by mouth 3 times a day for 3 days, to be increased, if necessary and in the absence of side effects, by 300 mg every 3 days to a maximum of 2,400 mg daily in divided doses. | Drug | Gabapentin |
| Placebo | Drug | Placebo |
Primary outcome
Change in scratching activity monitoring system
Time frame: 4 weeks
A scratching activity monitoring system specifically designed to record scratching behavior independent of gross body movement
1 secondary outcome
Change in visual analogue scale for pruritus
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2017.
- Results publication: PubMed 17058231Bergasa NV, McGee M, Ginsburg IH, Engler D. Gabapentin in patients with the pruritus of cholestasis: a double-blind, randomized, placebo-controlled trial. Hepatology. 2006 Nov;44(5):1317-23. doi: 10.1002/hep.21370.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nora V Bergasa, M.D. principal investigator
New York Presbyterian Hospital Columbia University College of Physicians and Surgeons
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gabapentin in people with Liver Disease and Cholestasis, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in scratching activity monitoring system (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00058890, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2017.