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Trial · NCT00407511

Outcomes11

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYChange From Baseline to End of Treatment (EOT) in Weekly Mean Pain Score on the Daily Pain Rating Scale (DPRS)Baseline, End of TreatmentFull Analysis Set (FAS): patients who took at least one dose of study medication, had a baseline value, and had at least one post-baseline measurement; Last Observation Carried Forward (LOCF).scores on scaleMEAN
SECONDARYChange From Baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS)Week 4, Week 8, Week 12Full Analysis Set (FAS).scores on scaleMEAN
SECONDARYChange From Baseline (BL) in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index ScoresBaseline, Week 8, Week 12, EOT/LOCFFull Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment.scores on scaleMEAN
SECONDARYChange From Baseline in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index ScoresBaseline, Week 8, Week 12, End of Treatment/Last Observation Carried Forward (EOT/LOCF)Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment.scores on scaleMEAN
SECONDARYPain Treatment Satisfaction Scale (PTSS): Impact of Current Pain MedicationBaseline, Week 8, Week 12, EOT/LOCF
Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment. Subjects were only included in the Week 8 analysis if their visit fell between Days 49 and 63, and were only included in the Week 12 analysis if their visit was after Day 78.
scores on scaleMEAN
SECONDARYPain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain MedicationBaseline, Week 8, Week 12, EOT/LOCF
Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment. Subjects were only included in the Week 8 analysis if their visit fell between Days 49 and 63, and were only included in the Week 12 analysis if their visit was after Day 78.
scores on scaleMEAN
SECONDARYChange From Baseline in Visual Analogue Scale for Pain (VAS-pain)Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, EOT/LOCFFull Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment.scores on scaleMEAN
SECONDARYChange From Baseline in Global Anxiety Visual Analogue Scale (GA-VAS)Baseline, Week 8, Week 12, EOT/LOCFFull Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment.scores on scaleMEAN
SECONDARYChange From Baseline in Mean Daily Sleep Interference Score (DSIS)Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, EOT/LOCFFull Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment.scores on scaleMEAN
SECONDARYPatient Global Impression of Change (PGIC)End of Treatment/ Last Observation Carried Forward (Week 12 or last post-baseline assessment)Full Analysis Set (FAS)participantsNUMBER
SECONDARYClinical Global Impression of Change (CGIC)End of Treatment/ Last Observation Carried Forward (Week 12 or last post-baseline assessment)Full Analysis Set (FAS)participantsNUMBER

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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