Comparison · NCT00075218-28fda557
Sunitinib Double-Blind Treatment vs Placebo Double-Blind Treatment: Subjects With Pain Relief Response Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Sunitinib Double-Blind Treatment vs Placebo Double-Blind Treatment: Subjects With Pain Relief Response Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI). Trial comparisons, record NCT00075218-28fda557. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00075218-28fda557
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.307 | 0.238 | 0.385 | wilson | |
| Risk in group 2 | 0.133 | 0.0741 | 0.228 | wilson | |
| Risk difference, group 1 minus group 2 | 0.173 | 0.0564 | 0.271 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.3 | 1.23 | 4.3 | log | |
| Odds ratio, group 1 over group 2 | 2.88 | 1.36 | 6.09 | log | |
| Number needed to treat, for one more participant with the outcome on Sunitinib Double-Blind Treatment than on Placebo Double-Blind Treatment | 5.77 | 3.69 | 17.7 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Sunitinib Double-Blind Treatment | Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. | 46 | 150 | OG000 |
| Group 2 | Placebo Double-Blind Treatment | Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding. | 10 | 75 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Subjects With Pain Relief Response Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI)
- Description
MPQ-PPI: 0=no pain to 5= excruciating pain. Pain Relief Response= 1) Decrease by \>= 1 points in MPQ-PPI score with either Decrease or No Change in total analgesic use \>= 50% over baseline OR 2) No change in MPQ-PPI score with Decrease total analgesic use \>= 50% over baseline.
- Time frame
- Day 1 & 28 of each cycle : duration of double-blind treatment phase
- Population
- Pain-Relief-Response population.
Source ClinicalTrials.gov
Trial
- Title
- A Study To Assess The Safety And Efficacy Of SU11248 In Patients With Gastrointestinal Stromal Tumor(GIST)
- NCT number
- NCT00075218
- Phases
- PHASE3
- Conditions
- Gastrointestinal Stromal Tumor
- Interventions
- Placebo, SU011248
- Lead sponsor
- Pfizer
- Results first posted
- 2009-09-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00075218?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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