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NCT05978063 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Efficacy and Safety of Oral Difelikefalin for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica
A Phase 2 study, sponsored by Cara Therapeutics.
- Terminated
- Registry status
- Phase 2
- Development phase
- 214
- Enrollment target
NCT05978063 is a Phase 2 study that was terminated before completion, run by Cara Therapeutics. The registered enrollment target is 214 participants.
The verdict
NCT05978063, a Phase 2 study, was terminated before completion, sponsored by Cara Therapeutics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 214 participants
- Enrollment target
Study Summary
This is a 2-part, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of twice-daily (BID) oral difelikefalin for moderate-to-severe pruritus in adult subjects with NP.
Interventions
- DRUG Placebo tablets
- DRUG difelikefalin 2.0 mg tablets
- DRUG difelikefalin 1.0 mg tablets
- DRUG difelikefalin 0.25 mg tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 214 participants |
| Start Date | 2023-08-01 |
| Est. Completion | 2024-05-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05978063
The ClinicalTrials.gov registry entry for NCT05978063 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 214 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 tablets is the first listed.
NCT05978063 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05978063 about?
NCT05978063 is a clinical study titled "Study to Evaluate the Efficacy and Safety of Oral Difelikefalin for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica". This is a 2-part, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of twice-daily (BID) oral difelikefalin for moderate-to-severe pruritus in adult subjects with NP.
What is the current status of trial NCT05978063?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 214 participants. The study started on 2023-08-01. Estimated completion is 2024-05-07.
What interventions are being tested in trial NCT05978063?
The interventions under investigation include: Placebo tablets (DRUG), difelikefalin 2.0 mg tablets (DRUG), difelikefalin 1.0 mg tablets (DRUG), difelikefalin 0.25 mg tablets (DRUG).
Who is sponsoring clinical trial NCT05978063?
This trial is sponsored by Cara Therapeutics, which has 23 total clinical trials registered on ClinicalTrials.gov.
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