Trial · NCT00760474
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Glutamine/Creatine (Gln/Cr) and Glutamate/Creatine (Glu/Cr) Ratios Measured by Proton Magnetic Resonance Spectroscopy (1H-MRS) | Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) | Full Analysis Set (FAS) all participants who received a minimum fixed dose of 300 mg/day of study treatment. N=number of participants with analyzable data at observation. | ratio | MEAN |
| PRIMARY | Voxel-wise Blood Oxygen Level Dependent (BOLD) Using Functional Magnetic Resonance Imaging (fMRI) of Brain Activation Signals in Response to Blunt Pressure Pain: Percent Change in BOLD Activations Including Outliers | Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) | FAS. Change from baseline for Period 1 and Period 2 summarized as Least Squares Mean (LS Mean). Abbreviation: Dorso Lateral Prefrontal Cortex (DLPFC). | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Voxel-wise Blood Oxygen Level Dependent (BOLD) Using Functional Magnetic Resonance Imaging (fMRI) of Brain Activation Signals in Response to a Control Visual (Checkerboard) Stimuli | Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) | FAS. | percent change in BOLD signal | MEAN |
| SECONDARY | Resting State Brain Activity (Connectivity Analysis) Assessed by Temporal Correlations in Low Frequency fMRI BOLD Signals Across Pain Processing Regions | Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) | Participants in FAS with quality resting state data (data able to be corrected for motion \[head and cardiorespiratory artifacts\]). | z-score | MEAN |
| SECONDARY | Gracely Box Scales for Pain Intensity (GBSint) Including Outliers | Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) | FAS | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Gracely Box Scales for Pain Unpleasantness (GBSunp) Including Outliers | Baseline/Pre-dose (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) | FAS | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Daily Pain Diary Numeric Rating Scale (NRS) Item From the Modified Brief Pain Inventory (mBPI) for Assessment of Clinical Pain: 7 Day Average Pain Score Including Outliers | Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) | FAS | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Daily Pain Diary Numeric Rating Scale (NRS) Item From the Modified Brief Pain Inventory (mBPI) for Assessment of Clinical Pain: 3 Day Average Pain Score Including Outliers | Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) | FAS | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Daily Pain Diary Numeric Rating Scale (NRS) Item From the Modified Brief Pain Inventory (mBPI) for Assessment of Clinical Pain: Individual Daily Pain Score Including Outliers | Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) | FAS | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Short-Form McGill Pain Questionnaire (SF-MPQ): Affective Total Score Including Outliers | Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) | FAS | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Short-Form McGill Pain Questionnaire (SF-MPQ): Sensory Total Score Including Outliers | Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) | FAS | scores on a scale | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Hospital Anxiety and Depression Scale (HADS): Anxiety Total Score Including Outliers | Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) | FAS. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. | scores on a scale | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Hospital Anxiety and Depression Scale (HADS): Depression Total Score Including Outliers | Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) | FAS. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. | scores on a scale | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Pain Catastrophizing Scale (PCS) Including Outliers | Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) | FAS | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Short-Form McGill Pain Questionnaire (SF-MPQ): Overall Score Including Outliers | Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) | FAS. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Sphygmomanometry Evoked Allodynia in Relation to the Blood Pressure (BP) Value at Which Allodynia Was Evoked | Day 58 | FAS; N=number of participants with analyzable data at observation. | mm Hg | MEAN |
| SECONDARY | Pain at the Bilateral Epicondyle Tender Points Assessed Using American College of Rheumatology (ACR) Classification Criteria | Day 58 | FAS; N=number of participants with analyzable data at observation. | scores on a scale | MEAN |
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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