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Trial · NCT00394901

Registered outcomes55

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryMean Pain Scores at EndpointWeek13/discontinuation
Endpoint mean pain score is defined as the mean of the last 7 daily pain diary rating while taking the study medication, up to and including day after last dose. Scores range from 0-10 (11 points ordinal) with higher scores indicating increased pain.
PrimaryMean Pain Score at Endpoint by Groups of Subjects With Expected Similar Plasma ConcentrationsWeek13/discontinuation
Endpoint mean pain score is defined as the mean of the last 7 daily pain diary rating while taking the study medication, up to and including day after last dose. Scores range from 0-10 (11 points ordinal) with higher scores indicating increased pain.
PrimaryNumber of RespondersWeek13/discontinuationA responder is defined as a subject with a 50% reduction in weekly mean pain score from baseline to endpoint.
PrimaryMean Pain Scores at Week 1Week 1Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
PrimaryMean Pain Scores at Week 2Week 2Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
PrimaryMean Pain Scores at Week 3Week 3Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
PrimaryMean Pain Scores at Week 4Week4Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
PrimaryMean Pain Scores at Week 5Week 5Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
PrimaryMean Pain Scores at Week 6Week 6Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
PrimaryMean Pain Scores at Week 7Week 7Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
PrimaryMean Pain Scores at Week 8Week 8Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
PrimaryMean Pain Scores at Week 9Week 9Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
PrimaryMean Pain Scores at Week 10Week 10Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
PrimaryMean Pain Scores at Week 11Week 11Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
PrimaryMean Pain Scores at Week 12Week 12Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
PrimaryMean Pain Scores at Week 13Week 13Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
SecondaryEndpoint Sensory Scores of the Short-Form McGill Pain QuestionnaireWeek13/discontinuationSensory score range from 0-33. Higher scores indicate more severe pain.
SecondaryEndpoint Affective Scores of the Short-Form McGill Pain QuestionnaireWeek13/discontinuationAffective score range from 0-12. Higher scores indicate more severe pain.
SecondaryEndpoint Total Scores of the Short-Form McGill Pain QuestionnaireWeek13/discontinuationTotal score range from 0-45. Higher scores indicate more severe pain.
SecondaryEndpoint Visual Analogue Scale Scores of the Short-Form McGill Pain QuestionnaireWeek13/discontinuationVisual Analogue Scale Score range from 0-100mm. Higher scores indicate more severe pain.

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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