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NCT03617536 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Safety and Efficacy of CR845 in Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus
A Phase 2 study, sponsored by Cara Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 269
- Enrollment target
NCT03617536 is a Phase 2 study that has completed, run by Cara Therapeutics. The registered enrollment target is 269 participants.
The verdict
NCT03617536, a Phase 2 study, has completed, sponsored by Cara Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 269 participants
- Enrollment target
Study Summary
This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of 3 dose levels of oral CR845 compared to placebo in reducing the intensity of itch in chronic kidney disease (CKD) patients with moderate-to-severe pruritus. This study will consist of a Screening Period, a 7-day Run-in Period, a 12 week Treatment Period, and a Follow-up Visit (approximately 7 days after the last dose of study drug).
Interventions
- DRUG Placebo Oral Tablet
- DRUG CR845 0.25 mg Oral Tablet
- DRUG CR845 0.5 mg Oral Tablet
- DRUG CR845 1 mg Oral Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 269 participants |
| Start Date | 2018-07-05 |
| Est. Completion | 2019-11-14 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03617536
The ClinicalTrials.gov registry entry for NCT03617536 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 269 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 4 interventions - of which Placebo Oral Tablet is the first listed.
NCT03617536 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03617536 about?
NCT03617536 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of CR845 in Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus". This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of 3 dose levels of oral CR845 compared to placebo in reducing the intensity of itch in chronic kidney disease (CKD) patients with moderate-to-severe pruritus. This study will consist of a S...
What is the current status of trial NCT03617536?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 269 participants. The study started on 2018-07-05. Estimated completion is 2019-11-14.
What interventions are being tested in trial NCT03617536?
The interventions under investigation include: Placebo Oral Tablet (DRUG), CR845 0.25 mg Oral Tablet (DRUG), CR845 0.5 mg Oral Tablet (DRUG), CR845 1 mg Oral Tablet (DRUG).
Who is sponsoring clinical trial NCT03617536?
This trial is sponsored by Cara Therapeutics, which has 23 total clinical trials registered on ClinicalTrials.gov.
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