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Study to Evaluate the Efficacy and Safety of Oral Difelikefalin for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica

NCT05978063 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2024-06-21

No results posted yet for this 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.

Conditions

Interventions

DRUG

difelikefalin 2.0 mg tablets

Oral difelikefalin 2.0 mg administered twice daily

DRUG

difelikefalin 1.0 mg tablets

Oral difelikefalin 1.0 mg administered twice daily

DRUG

difelikefalin 0.25 mg tablets

Oral difelikefalin 0.25 mg administered twice daily

DRUG

Placebo tablets

Oral Placebo administered twice daily

Sponsors & Collaborators

  • Cara Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Cara Therapeutics · Cara Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2024-04-22
Completion
2024-05-07
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Germany
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05978063 on ClinicalTrials.gov