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Clinical Trial Details

Trial ID: L0126
Source ID: NCT03617536
Associated Drug: Cr845 0.25 Mg Oral Tablet
Title: A Study to Evaluate the Safety and Efficacy of CR845 in Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03617536/results
Conditions: Chronic Kidney Diseases|Pruritus
Interventions: DRUG: CR845 0.25 mg Oral Tablet|DRUG: CR845 0.5 mg Oral Tablet|DRUG: CR845 1 mg Oral Tablet|DRUG: Placebo Oral Tablet
Outcome Measures: Primary: Change From Baseline in Weekly Mean of the Daily 24-hour Worst Itching Intensity Numerical Rating Scale (NRS) Score During Week 12, Intensity of itch will be measured using an NRS used to indicate the intensity of the worst itching over the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "no itching" and "10" represents "worst itching imaginable". Higher scores meant worse itch intensity., Baseline, Week 12 | Secondary: Change From Baseline in Total Skindex-10 Scale Score at the End of Week 12, The Skindex-10 Scale is a multidimensional questionnaire which assesses itch-related quality of life over the past week. The questions cover 3 domains: disease, mood/emotional distress, and social functioning domain. The Skindex-10 has 10 questions; the total Skindex-10 score ranges from 0 to 60. A lower total score represents better quality of life., Baseline, Week 12|Change From Baseline in 5-D Itch Scale Score at the End of Week 12, The 5-D Itch Scale is a multidimensional questionnaire which assesses itch-related quality of life over the past 2 weeks. The questions cover five dimensions of itch including the degree, duration of itch/day, direction (improvement/worsening), disability (impact on activities such as work), and body distribution of itch. The 5-D Itch Scale has 5 questions; the total 5-D Itch Scale score ranges from 5 to 25, with higher scores indicating worse responses., Baseline, Week 12|Reduction of Itch Intensity as Assessed by the Proportion of Patients Achieving an Improvement From Baseline ≥3 Points With Respect to the Weekly Mean of the Daily 24-hour Worst Itching Intensity NRS Score at Week 12, Week 12
Sponsor/Collaborators: Sponsor: Cara Therapeutics, Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 269
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2018-07-05
Completion Date: 2019-11-14
Results First Posted: 2024-01-24
Last Update Posted: 2024-01-24
Locations: Cara Therapeutics Study Site, Birmingham, Alabama, 35233, United States|Cara Therapeutics Study Site, Florence, Alabama, 35630, United States|Cara Therapeutics Study Site, Phoenix, Arizona, 85016, United States|Cara Therapeutics Study Site, Prescott, Arizona, 86401, United States|Cara Therapeutics Study Site, Sun City, Arizona, 85351, United States|Cara Therapeutics Study Site, Harrisburg, Arkansas, 72432, United States|Cara Therapeutics Study Site, Bakersfield, California, 93309, United States|Cara Therapeutics Study Site 2, Bakersfield, California, 99309, United States|Cara Therapeutics Study Site, Canyon Country, California, 91351, United States|Cara Therapeutics Study Site, Escondido, California, 92025, United States|Cara Therapeutics Study Site, Lomita, California, 90717, United States|Cara Therapeutics Study Site, Northridge, California, 91324, United States|Cara Therapeutics Study Site, Riverside, California, 92505, United States|Cara Therapeutics Study Site, Sacramento, California, 95831, United States|Cara Therapeutics Study Site, Whittier, California, 90602, United States|Cara Therapeutics Study Site, Denver, Colorado, 80230, United States|Cara Therapeutics Study Site, Washington, District of Columbia, 20037, United States|Cara Therapeutics Study Site, Edgewater, Florida, 32132, United States|Cara Therapeutics Study Site, Hialeah, Florida, 33016, United States|Cara Therapeutics Study Site, Hollywood, Florida, 33024, United States|Cara Therapeutics Study Site, Lake Worth, Florida, 33467, United States|Cara Therapeutics Study Site 1, Miami, Florida, 33125, United States|Cara Therapeutics Study Site 2, Miami, Florida, 33155, United States|Cara Therapeutics Study Site, Ocala, Florida, 34471, United States|Cara Therapeutics Study Site, Orlando, Florida, 32810, United States|Cara Therapeutics Study Site, Tampa, Florida, 33614, United States|Cara Therapeutics Study Site, Temple Terrace, Florida, 33637, United States|Cara Therapeutics Study Site, Augusta, Georgia, 30909, United States|Cara Therapeutics Study Site, Sandy Springs, Georgia, 30328, United States|Cara Therapeutics Study Site, Crystal Lake, Illinois, 60012, United States|Cara Therapeutics Study Site, Evanston, Illinois, 60201, United States|Cara Therapeutics Study Site, Iowa City, Iowa, 52242, United States|Cara Therapeutics Study Site, Metairie, Louisiana, 70006, United States|Cara Therapeutics Study Site, New Orleans, Louisiana, 70115, United States|Cara Therapeutics Study Site, Zachary, Louisiana, 70791, United States|Cara Therapeutics Study Site, Baltimore, Maryland, 21287, United States|Cara Therapeutics Study Site, Takoma Park, Maryland, 20912, United States|Cara Therapeutics Study Site, Flint, Michigan, 48503, United States|Cara Therapeutics Study Site 2, Flint, Michigan, 48532, United States|Cara Therapeutics Study Site, Roseville, Michigan, 48066, United States|Cara Therapeutics Study Site, Saint Clair, Michigan, 48081, United States|Cara Therapeutics Study Site, Kansas City, Missouri, 64111, United States|Cara Therapeutics Study Site, Brooklyn, New York, 11229, United States|Cara Therapeutics Study Site, Mineola, New York, 11501, United States|Cara Therapeutics Study Site, Rocky Mount, North Carolina, 27804, United States|Cara Therapeutics Study Site, Columbus, Ohio, 43215, United States|Cara Therapeutics Study Site, Norman, Oklahoma, 73071, United States|Cara Therapeutics Study Site, Camp Hill, Pennsylvania, 17011, United States|Cara Therapeutics Study Site, Providence, Rhode Island, 02903, United States|Cara Therapeutics Study Site, Warwick, Rhode Island, 02886, United States|Cara Therapeutics Study Site, Greenville, South Carolina, 29605, United States|Cara Therapeutics Study Site, Rapid City, South Dakota, 57702, United States|Cara Therapeutics Study Site, Corsicana, Texas, 75110, United States|Cara Therapeutics Study Site, Gonzales, Texas, 78629, United States|Cara Therapeutics Study Site, Houston, Texas, 77074, United States|Cara Therapeutics Study Site, Houston, Texas, 77081, United States|Cara Therapeutics Study Site, Plano, Texas, 75093, United States|Cara Therapeutics Study Site, San Antonio, Texas, 78207, United States|Cara Therapeutics Study Site, San Antonio, Texas, 78224, United States|Cara Therapeutics Study Site, Alexandria, Virginia, 22304, United States
URL: https://clinicaltrials.gov/show/NCT03617536

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress