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Trial · NCT01903005

Outcomes11

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

TypeOutcomeTime framePopulationUnitsMeasured as
SECONDARYRetention in Treatment in the Safety PopulationTreatment retention was assessed at weeks 4, 8, 12, 16, 20, and 24Safety populationparticipantsNUMBER
SECONDARYMean Change From Primary Study Baseline (OX219-006 or OX219-007) in Clinical Opioid Withdrawal Scale (COWS) ScorePrior to dosing on day 1, at weeks 4, 8,12,16, 20, 24, and at study endpointSafety population; patient population at day 1 (n=658) is lower than overall safety population (n=665) due to missing dataunits on a scaleMEAN
SECONDARYMean Change From Primary Study Baseline (OX219-006 or OX219-007) in Subjective Opioid Withdrawal Scale (SOWS) ScorePrior to dosing on day 1, at weeks 4, 8,12,16, 20, and 24, and at study endpointSafety population; patient population at day 1 (n=650) is lower than overall safety population (n=665) due to missing dataunits on a scaleMEAN
SECONDARYMean Change From Primary Study Baseline (OX219-006 and OX219-007) in Visual Analog Scale (VAS) Craving ScoresPrior to dosing on day 1, at weeks 4, 8, 12, 16, 20, and 24, and at study endpointSafety population; patient population at day 1 (n=646) is lower than overall safety population (n=665) due to missing dataunits on a scaleMEAN
SECONDARYPercent Change From Primary Study Baseline (OX219-006 or OX219-007) for Question 1 of the Work Productivity/Activity Impairment: 6-Question Specific Health Problem Questionnaire (WPAI:SHP)Study EndpointSafety population; patients with missing data were excluded from the analysis and are reflected in the number of patients analyzedpercentage of patientsNUMBER
SECONDARYMean Change From Primary Study Baseline (OX219-006 or OX219-007) for Questions 2-4 of the WPAI:SHPWeek 24Safety population; patients with missing data were excluded from the analysis and are reflected in the number of participants analyzedhoursMEAN
SECONDARYMean Change From Primary Study Baseline (OX219-006 or OX219-007) for Questions 5-6 of the WPAI:SHPWeek 24Safety population; patients with missing data were excluded from the analysis and are reflected in the number of participants analyzedunits on a scaleMEAN
PRIMARYNumber of Patients Reporting Treatment-Emergent Adverse EventsDay 1 through week 24Safety populationparticipantsNUMBER
PRIMARYNumber of Patients Reporting Treatment-Related, Treatment-Emergent Adverse EventsDay 1 through week 24Safety populationparticipantsNUMBER
PRIMARYNumber of Patients Reporting Treatment-Emergent Serious Adverse EventsDay 1 throught week 24Safety populationparticipantsNUMBER
PRIMARYNumber of Patient Discontinuations Due to Treatment-Emergent Adverse EventsDay 1 through week 24Safety populationparticipantsNUMBER

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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