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Trial · NCT02196324

Outcomes17

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYAverage Visual Analog Scale at BaselineAt BaselineThe Intent-to-treat (ITT) population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.Units on a scaleMEAN
PRIMARYAverage Visual Analog Scale at Week 2At Week 2
The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.~Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.
Units on a scaleMEAN
PRIMARYAverage Visual Analog Scale at Week 4At Week 4
The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.~Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.
Units on a scaleMEAN
PRIMARYAverage Visual Analog Scale at Week 8At Week 8
Intent-to-treat (ITT) population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.~Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.
Units on a scaleMEAN
SECONDARYNumber of Participants With Improvement in Pruritus as Reported on Verbal Rating Scale (VRS) - PruritusAt Baseline and Week 8
The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.~Here, number analyzed in each row signifies only the participants with available data that were analyzed for each parameter.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With Improvement in Burning as Reported on Verbal Rating Scale (VRS) - BurningAt Baseline and Week 8
The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.~Here, number analyzed in each row signifies only the participants with available data that were analyzed for each parameter.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With Improvement in Stinging as Reported on Verbal Rating Scale (VRS) - StingingAt Baseline and Week 8
The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.~Here, number analyzed in each row signifies only the participants with available data that were analyzed for each parameter.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYWorst Visual Analog Scale (VAS)At Baseline, Weeks 2, 4, and 8
The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.~Here, number analyzed in each row signifies only the participants with available data that were analyzed for each parameter.
Units on a scaleMEAN
SECONDARYNumber of Participants With Improvement in Pruritus as Reported on Patient Global Assessment (PGA)At Weeks 2, 4, and 8
The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.~Here, number analyzed in each row signifies only the participants with available data that were analyzed for each parameter.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumeric Rating Scale (NRS)At Baseline, Weeks 2, 4, and 8The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.Units on a scaleMEAN
SECONDARYDermatology Life Quality Index (DLQI)At Baseline, Weeks 2, 4, and 8
The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.~Here, number analyzed in each row signifies only the participants with available data that were analyzed for each parameter.
Units on a scaleMEAN
SECONDARYPruritus-specific Quality of Life (ItchyQoL)At Baseline, Weeks 2, 4, and 8
The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.~Here, number analyzed in each row signifies only the participants with available data that were analyzed for each parameter.
Units on a scaleMEAN
SECONDARYPatient Benefit Index, Version for Patients With Pruritus (PBI-P)At Week 8 / End of Treatment
The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.~Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.
Units on a scaleMEAN
SECONDARYNumber of Participants With Improvement in PN Lesions as Reported on Investigator Global Assessment (IGA)At Week 8
The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.~Here, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With Improvement on Prurigo Activity Score (PAS)At Day 1 and Week 8
The ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.~Here, number analyzed in each row signifies only the participants with available data that were analyzed for each day and week.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYParticipants With Rescue Medication UsagePre-treatment, upto 8 WeeksThe ITT population - all randomized participants who were treated. This population was analyzed based upon the treatment to which participants were randomized.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With Adverse Events (AEs)From the time of informed consent (Screening) until the last study visit (follow-up phone call, Week 10)
Safety population - participants who received at least one dose of study drug. This population was analyzed based upon the actual treatment received. Participants with dosing errors were assigned to a treatment group based upon the treatment they received most often.
ParticipantsCOUNT_OF_PARTICIPANTS

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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