Pruritus With Chronic Liver DiseasePhase 2NCT00638495
Phase II Study of TRK-820 Soft Capsules - Intractable Pruritus in Patients With Chronic Liver Disease -
A Phase 2 study testing Nalfurafine Hydrochloride (TRK-820) in people with Pruritus With Chronic Liver Disease, run by Toray Industries, Inc at 1 site in Japan.
Trial summary
The efficacy and safety of TRK-820 are to be evaluated in the treatment of intractable pruritus in patients with Chronic Liver Disease by administering 2.5, 5 and 10 microg of this drug or placebo for 28 days in four groups with a design of randomized, double-blind, parallel-group comparison. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pruritus With Chronic Liver Disease
- What is being tested?
- Nalfurafine Hydrochloride (TRK-820)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteJapan
- Study dates
- Mar 2008to Dec 2009
- Phase
- Phase 2
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic Liver Disease is present; and the patient's general condition is judged by the physician to be stable with no prospect of an abrupt change in pathophysiology.
- It can be confirmed by either of the following that treatment of pruritus with antihistamines or antiallergics has not been adequately effective in such patients:
Who cannot join
- Malignant tumors
- Depression, integration dysfunction syndrome (schizophrenia), or dementia
- Hepatic encephalopathy, or hepatic cirrhosis in which ascites or esophageal or gastric aneurysm cannot be controlled
- Alcoholic liver disease
- Atopic dermatitis, chronic urticaria, or other skin disease producing generalized pruritus that is judged by the physician to affect the assessment of pruritus associated with Chronic Liver Disease in this study
- Allergy to opioid drugs
- Drug dependence or alcohol dependence
- Chronic renal failure
Trial locations and contacts
1 site in 1 country.
About this study
The efficacy and safety of TRK-820 are to be evaluated in the treatment of intractable pruritus in patients with Chronic Liver Disease by administering 2.5, 5 and 10 microg of this drug or placebo for 28 days in four groups with a design of randomized, double-blind, parallel-group comparison. In addition, the plasma concentrations of TRK-820 and its primary metabolites are to be determined.
- Conditions
- Pruritus With Chronic Liver Disease
- Being tested
- Nalfurafine Hydrochloride (TRK-820), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nalfurafine Hydrochloride (TRK-820)Drug
Also called REMITCH
TRK-820 2.5, 5 and 10 microg is to be administered orally once daily, after supper in principle, for 28 days.
PlaceboDrug
Placebo is to be administered orally once daily, after supper in principle, for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Nalfurafine Hydrochloride (TRK-820) |
| 2 | 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 VAS value (based on morning or evening scores, whichever larger, during the treatment period [4th week])
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 posted19 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pruritus With Chronic Liver DiseaseStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Toray Industries, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00638495
- Sponsor's protocol ID
- 820HPC01
- Status last verified
- Jan 2010
- First submitted
- 12 Mar 2008
- Last updated
- 1 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of TRK-820 Soft Capsules - Intractable Pruritus in Patients With Chronic Liver Disease -
- ClinicalTrials.gov ID
- NCT00638495
- Acronym / sponsor ID
- 820HPC01
- Conditions
- Pruritus With Chronic Liver Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Toray Industries, IncIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 19 Mar 2008 (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.
The efficacy and safety of TRK-820 are to be evaluated in the treatment of intractable pruritus in patients with Chronic Liver Disease by administering 2.5, 5 and 10 microg of this drug or placebo for 28 days in four groups with a design of randomized, double-blind, parallel-group comparison. In addition, the plasma concentrations of TRK-820 and its primary metabolites are to be determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Nalfurafine Hydrochloride (TRK-820) |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chronic Liver Disease is present; and the patient's general condition is judged by the physician to be stable with no prospect of an abrupt change in pathophysiology.
- It can be confirmed by either of the following that treatment of pruritus with antihistamines or antiallergics has not been adequately effective in such patients:
Key exclusion criteria (8 listed)
- Malignant tumors
- Depression, integration dysfunction syndrome (schizophrenia), or dementia
- Hepatic encephalopathy, or hepatic cirrhosis in which ascites or esophageal or gastric aneurysm cannot be controlled
- Alcoholic liver disease
- Atopic dermatitis, chronic urticaria, or other skin disease producing generalized pruritus that is judged by the physician to affect the assessment of pruritus associated with Chronic Liver Disease in this study
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 |
|---|---|---|
| Nalfurafine Hydrochloride (TRK-820)Also: REMITCHTRK-820 2.5, 5 and 10 microg is to be administered orally once daily, after supper in principle, for 28 days. | Drug | 1 |
| PlaceboPlacebo is to be administered orally once daily, after supper in principle, for 28 days. | Drug | 2 |
Primary outcome
Change in VAS value (based on morning or evening scores, whichever larger, during the treatment period [4th week])
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 1 Feb 2010.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nalfurafine Hydrochloride (TRK-820) in people with Pruritus With Chronic Liver Disease, run by Toray Industries, Inc at 1 site in Japan.
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 2 inclusion and 8 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 1 Feb 2010. 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 Japan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 VAS value (based on morning or evening scores, whichever larger, during the treatment period [4th week]) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Feb 2010.