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Trial · NCT03202979

Registered outcomes14

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

ListOutcomeTime frameDescription
PrimaryChange of item 5 score in Brief Pain Inventory Short Form (BPI-SF) scaleBaseline - Day 56Change from baseline of item 5 score in BPI-SF numering scale after 56 days.
SecondaryChange of item 5 score in Brief Pain Inventory Short Form (BPI-SF) scaleBaseline - Days 7, 14, 21, 28, 35, 42, 49, 63Change from baseline of item 5 score in BPI-SF numering scale after 7, 14, 21, 28, 35, 42, 49 and 63 days.
SecondaryChange of item 3 score in Brief Pain Inventory Short Form (BPI-SF) scaleBaseline - Days 7, 14, 21, 28, 35, 42, 49, 56 and 63.Change from baseline of item 3 score in BPI-SF numering scale after 7, 14, 21, 28, 35, 42, 49, 56 and 63 days.
SecondaryChange of item 4 score in Brief Pain Inventory Short Form (BPI-SF) scaleBaseline - Days 7, 14, 21, 28, 35, 42, 49, 56 and 63.Change from baseline of item 4 score in BPI-SF numering scale after 7, 14, 21, 28, 35, 42, 49, 56 and 63 days.
SecondaryChange of item 5 score in Brief Pain Inventory Short Form (BPI-SF) scaleBaseline - Days 7, 14, 21, 28, 35, 42, 49, 56 and 63.Change from baseline of item 5 score in BPI-SF numering scale after 7, 14, 21, 28, 35, 42, 49, 56 and 63 days.
SecondaryChange of item 6 score in Brief Pain Inventory Short Form (BPI-SF) scaleBaseline - Days 7, 14, 21, 28, 35, 42, 49, 56 and 63.Change from baseline of item 6 score in BPI-SF numering scale after 7, 14, 21, 28, 35, 42, 49, 56 and 63 days.
SecondaryChange of item 8 score in Brief Pain Inventory Short Form (BPI-SF) scaleBaseline - Days 7, 14, 21, 28, 35, 42, 49, 56 and 63.Change from baseline of item 8 score in BPI-SF numering scale after 7, 14, 21, 28, 35, 42, 49, 56 and 63 days.
SecondaryChange of item 9 score in Brief Pain Inventory Short Form (BPI-SF) scaleBaseline - Days 7, 14, 21, 28, 35, 42, 49, 56 and 63.Change from baseline of item 9 score in BPI-SF numering scale after 7, 14, 21, 28, 35, 42, 49, 56 and 63 days.
SecondaryChange in Neuropathic Pain Symptom Inventory (NPSI) scaleBaseline - Days 7, 14, 21, 28, 35, 42, 49, 56 and 63.Change from baseline of total score in NPSI scale after 7, 14, 21, 28, 35, 42, 49, 56 and 63 days.
SecondaryChange in 36-item Short-Form Health Survey (SF-36)Baseline - Day 56Change from baseline of SF-36 after 56 days.
SecondaryChange in Hamilton Anxiety Rating Scale (HAM-A)Baseline - Days 7, 14, 21, 28, 35, 42, 49, 56 and 63.Change from baseline of total score in HAM-A scale after 7, 14, 21, 28, 35, 42, 49, 56 and 63 days.
SecondaryPatient Global Impression of Change (PGIC)Days 7, 14, 21, 28, 35, 42, 49, 56 and 63.Assessment by patient of the overall efficacy and tolerability by PGIC after 7, 14, 21, 28, 35, 42, 49, 56 and 63 days
SecondaryChange in Leeds Sleep Evaluation Questionnaire (LSEQ)Baseline - Days 7, 14, 21, 28, 35, 42, 49, 56 and 63.Change from baseline in LSEQ after 7, 14, 21, 28, 35, 42, 49, 56 and 63 days.
SecondaryFrequency of treatment-related adverse events9 weeksMonitoring of the frequency of adverse events, physical examination, vital signs, ECG, laboratory analyses

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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