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NCT05533008 · ClinicalTrials.gov registry record · Phase 1
CR845-100303: Study to Assess the Potential of Physical Withdrawal From Intravenous CR845 (Difelikefalin) in Hemodialysis Patients
A Phase 1 study, sponsored by Cara Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
NCT05533008 is a Phase 1 study that has completed, run by Cara Therapeutics. The registered enrollment target is 35 participants.
The verdict
NCT05533008, a Phase 1 study, has completed, sponsored by Cara Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
Study Summary
This is a multicenter, randomized, double-blind, placebo-controlled study to assess the potential of physical withdrawal from CR845 upon treatment discontinuation after 3 weeks of IV administration at a dose of 0.5 mcg/kg in hemodialysis patients. The purpose of this study is to determine whether hemodialysis patients who take CR845 develop physical dependence and experience withdrawal symptoms upon cessation, as exemplified by symptoms consistent with opioid withdrawal. The study will consist of a Screening Phase, a 3-week Open-label Phase, a 2-week randomized, placebo-controlled, Double-blind Phase and a Follow-up Visit.
Interventions
- OTHER Placebo
- DRUG CR845 0.5 mcg/kg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2019-12-31 |
| Est. Completion | 2020-06-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05533008
The ClinicalTrials.gov registry entry for NCT05533008 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cara Therapeutics, which has 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05533008 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05533008 about?
NCT05533008 is a clinical study titled "CR845-100303: Study to Assess the Potential of Physical Withdrawal From Intravenous CR845 (Difelikefalin) in Hemodialysis Patients". This is a multicenter, randomized, double-blind, placebo-controlled study to assess the potential of physical withdrawal from CR845 upon treatment discontinuation after 3 weeks of IV administration at a dose of 0.5 mcg/kg in hemodialysis patients. The purpose of this study is to determine whether he...
What is the current status of trial NCT05533008?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2019-12-31. Estimated completion is 2020-06-11.
What interventions are being tested in trial NCT05533008?
The interventions under investigation include: Placebo (OTHER), CR845 0.5 mcg/kg (DRUG).
Who is sponsoring clinical trial NCT05533008?
This trial is sponsored by Cara Therapeutics, which has 23 total clinical trials registered on ClinicalTrials.gov.
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