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NCT01660243 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of MT-9938 for Treatment of Uremic Pruritus in Subjects With End-stage Renal Disease Receiving Hemodialysis
A Phase 2 study, sponsored by Toray Industries.
- Terminated
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
NCT01660243 is a Phase 2 study that was terminated before completion, run by Toray Industries. The registered enrollment target is 45 participants.
The verdict
NCT01660243, a Phase 2 study, was terminated before completion, sponsored by Toray Industries.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
Study Summary
This study is being conducted to investigate the efficacy of MT-9938 compared with placebo after 2 weeks, to continue to evaluate efficacy for an additional 6 weeks, and to explore the effect of a reduction in itching intensity on health-related Quality of Life(QoL) domains, especially those which recent research suggests have a positive correlation with overall survival for this patient group. The study will consist of the following phases: Screening (1 to 2 weeks), Run in (1 week), double-blind Treatment (8 weeks), Washout (1 week) culminating in a Follow-up Visit (1 week after the last dose).
Interventions
- DRUG Placebo
- DRUG Nalfurafine hydrochloride(MT-9938) 2.5μg
- DRUG Nalfurafine hydrochloride(MT-9938) 5μg
- DRUG Nalfurafine hydrochloride(MT-9938) 10μg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2012-09 |
| Est. Completion | 2014-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01660243
The ClinicalTrials.gov registry entry for NCT01660243 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Toray Industries, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01660243 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01660243 about?
NCT01660243 is a clinical study titled "Efficacy and Safety of MT-9938 for Treatment of Uremic Pruritus in Subjects With End-stage Renal Disease Receiving Hemodialysis". This study is being conducted to investigate the efficacy of MT-9938 compared with placebo after 2 weeks, to continue to evaluate efficacy for an additional 6 weeks, and to explore the effect of a reduction in itching intensity on health-related Quality of Life(QoL) domains, especially those which r...
What is the current status of trial NCT01660243?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2012-09. Estimated completion is 2014-03.
What interventions are being tested in trial NCT01660243?
The interventions under investigation include: Placebo (DRUG), Nalfurafine hydrochloride(MT-9938) 2.5μg (DRUG), Nalfurafine hydrochloride(MT-9938) 5μg (DRUG), Nalfurafine hydrochloride(MT-9938) 10μg (DRUG).
Who is sponsoring clinical trial NCT01660243?
This trial is sponsored by Toray Industries, which has 5 total clinical trials registered on ClinicalTrials.gov.
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