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Trial · NCT04622735

Outcomes18

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYRanked Endpoints : 1. Sum of Pain Intensity Differences at 6 Hours (SPID0-6h)6 hours post-dosescore on a scaleMEAN
PRIMARYTotal Pain Relief at 6 Hours (TOTPAR0-6h)6 hours post-dosescore on a scaleMEAN
PRIMARYProportion of Responder Patients6 hours post-doseParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYThe Patient's Global Impression of Change (PGIC) Questionnaire6 hours post-doseParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYThe Onset of Pain Reliefduring the first 6 hoursParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYTotal Pain Relief at 1 Hour (TOTPAR0-1h), 2 Hours (TOTPAR0-2h), 3 Hours (TOTPAR0-3h), and 4 Hours (TOTPAR0-4h)At 1 hour, 2 hours, 3 hours, and 4 hoursscore on a scaleMEAN
SECONDARYSum of Pain Intensity Differences at 1 Hour (SPID0-1h), 2 Hours (SPID0-2h), 3 Hours (SPID0-3h), and 4 Hours (SPID0-4h)At 1 hour, 2 hours, 3 hours, and 4 hoursscore on a scaleMEAN
SECONDARYThe Pain Intensity Differences (PID) AssessmentAt each timepoint: 30min, At 45min, until at 360 min post-doseunits on a scaleMEAN
SECONDARYProportion of Responder Patients.At 1 hour, 2 hours, 3 hours and 4 hours.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYTime to the Second Investigational Medicinal Product (IMP) IntakeUp to 5 days after first doseminutesMEDIAN
SECONDARYParticipant Having Taken a Rescue Analgesic TreatmentUp to 10 days after first doseParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYSum of Pain Intensity DifferencesAt days 1, 2, 3, 4 and 5score on a scaleMEAN
SECONDARYProportion of Patients Having Taken a Rescue Analgesic Treatment Throughout the Study.Up to 10 days after first doseParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYThe Total Dose of Rescue Medication Taken.Up to 10 days after first dosemgMEAN
SECONDARYMean Duration Under Rescue Medication Over the 5 Days.Up to 5 days after first dosehoursMEAN
SECONDARYNumber of Investigational Medicinal Product (IMP) IntakesUp to 5 days after first doseintakeMEAN
SECONDARYPatient's Global Impression of Change (PGIC) ScoreUp to 10 days after first doseParticipantsCOUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIEDOccurrence of Adverse Events (Serious and Non-serious Adverse Events).Up to 10 days after first doseAll population has been analysedAdverse EventNUMBER

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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GET https://conductscience.org/api/trials/v1/NCT04622735/outcomes