Trial · NCT01506453
Therapeutic Interventions For Pain Induced By Vincristine Treatment For Childhood Acute Lymphoblastic Leukemia (ALL)
NCT01506453, Phase 2, Completed, St. Jude Children's Research Hospital; results first posted 2019-06-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Therapeutic Interventions For Pain Induced By Vincristine Treatment For Childhood Acute Lymphoblastic Leukemia (ALL). Trials, record NCT01506453. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01506453
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Therapeutic Interventions For Pain Induced By Vincristine Treatment For Childhood Acute Lymphoblastic Leukemia (ALL)
- NCT number
- NCT01506453
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 51 participants, actual
- Lead sponsor
- St. Jude Children's Research Hospital
- Conditions
- Acute Lymphoblastic Leukemia, Neuropathy, Neuropathic Pain
- Interventions
- gabapentin, placebo
- First posted
- 2012-01-10
- Last updated
- 2019-06-19
- Results first posted
- 2019-06-19
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Daily Total Dose of Oral Morphine (mg/kg/Day). | Daily beginning day 1 for a maximum of 21 days. | The response to therapy will be measured by pain intensity scores and daily use of morphine doses for breakthrough pain as described in the study objectives. Daily assessments will continue during treatment with the study drug (gabapentin or placebo) irrespective of patient response to study treatment. and toddlers (less than age 4 years) or other children who cannot self report, use the FLACC Scale Score each component as a subscore (face, legs, activity, cry, consolability) Total subscores to determine FLACC score Older children (ages 4 to 7 years) who can self-report, use the Faces Pain Scale-Revised (FPS-R) Ages \>7 years, Self report using a numeric scale 0-10 without reference to Faces Pain Scale-Revised (FPS-R) Pain score 0 means no pain and 10 means worst pain. The scale information for the FLACC and FPS-R scales are similar. |
| Secondary | Pain Scores Right Now | Daily beginning day 1 through a maximum of 21 days. | A score ranging from 0 to 10, measured by age appropriate validated pain scale. Because there was only one patient during day 21 time point for this treatment group, the mean and standard deviation could not be calculated. Infants and toddlers (less than age 4 years) or other children who cannot self report, use the FLACC Scale Score each component as a subscore (face, legs, activity, cry, consolability) Total subscores to determine FLACC score Older children (ages 4 to 7 years) who can self-report, use the Faces Pain Scale-Revised (FPS-R) Ages \>7 years, Self report using a numeric scale 0-10 without reference to Faces Pain Scale-Revised (FPS-R) Pain score 0 means no pain and 10 means worst pain.The scale information for the FLACC and FPS-R scales are similar. |
| Secondary | Pain Score During the Previous 24 Hours | Daily beginning day 1 through a maximum of 21 days | A score ranging from 0 to 10, measured by age appropriate validated pain scale. Because there was only one patient during day 21 time point for this treatment group, the mean and standard deviation could not be calculated.Infants and toddlers (less than age 4 years) or other children who cannot self report, use the FLACC Scale Score each component as a subscore (face, legs, activity, cry, consolability) Total subscores to determine FLACC score Older children (ages 4 to 7 years) who can self-report, use the Faces Pain Scale-Revised (FPS-R) Ages \>7 years, Self report using a numeric scale 0-10 without reference to Faces Pain Scale-Revised (FPS-R) Pain score 0 means no pain and 10 means worst pain.The scale information for the FLACC and FPS-R scales are similar. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Daily Total Dose of Oral Morphine (mg/kg/Day). | Daily beginning day 1 for a maximum of 21 days. | The daily morphine dosage will be modeled as longitudinal observations with treatment (gabapentin vs. placebo) group, and if necessary, other clinical factors such as age category for pain assessment (0-3yr, 4-7yr, \>7yr), baseline pain score, and ALL risk classification, as explanatory factors, using repeated measure linear models | mg/kg/day | MEAN |
| SECONDARY | Pain Scores Right Now | Daily beginning day 1 through a maximum of 21 days. | There were participants in the Gabapentin and Placebo groups that did not have pain assessments at various time points. Pain score was 0 for each placebo participant on days 19, 20 and 21. | score on a scale 0-10 | MEAN |
| SECONDARY | Pain Score During the Previous 24 Hours | Daily beginning day 1 through a maximum of 21 days | There were participants in the Gabapentin and Placebo groups that did not have pain assessments at various time points. Pain score was 0 for each placebo participant on days 20 and 21. | score on a scale 0-10 | MEAN |
Source ClinicalTrials.gov
Results by group123
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Daily Total Dose of Oral Morphine (mg/kg/Day). | Gabapentin | Day 1 | 0.38267 | Standard Deviation 0.28921 | mg/kg/day |
| Daily Total Dose of Oral Morphine (mg/kg/Day). | Placebo | Day 1 | 0.27433 | Standard Deviation 0.19299 | mg/kg/day |
| Daily Total Dose of Oral Morphine (mg/kg/Day). | Gabapentin | Day 2 | 0.43685 | Standard Deviation 0.33788 | mg/kg/day |
| Daily Total Dose of Oral Morphine (mg/kg/Day). | Placebo | Day 2 | 0.31816 | Standard Deviation 0.16012 | mg/kg/day |
| Daily Total Dose of Oral Morphine (mg/kg/Day). | Gabapentin | Day 3 | 0.37281 | Standard Deviation 0.32935 | mg/kg/day |
| Daily Total Dose of Oral Morphine (mg/kg/Day). | Placebo | Day 3 | 0.27961 | Standard Deviation 0.18509 | mg/kg/day |
| Daily Total Dose of Oral Morphine (mg/kg/Day). | Gabapentin | Day 4 | 0.40384 | Standard Deviation 0.32469 | mg/kg/day |
| Daily Total Dose of Oral Morphine (mg/kg/Day). | Placebo | Day 4 | 0.35343 | Standard Deviation 0.18688 | mg/kg/day |
| Daily Total Dose of Oral Morphine (mg/kg/Day). | Gabapentin | Day 5 | 0.37662 | Standard Deviation 0.31263 | mg/kg/day |
| Daily Total Dose of Oral Morphine (mg/kg/Day). | Placebo | Day 5 | 0.37920 | Standard Deviation 0.22471 | mg/kg/day |
1 to 10 of 123Source ClinicalTrials.gov
See all 123 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Gabapentin | 25 | |
| Overall Study | STARTED | Placebo | 26 | |
| Overall Study | COMPLETED | Gabapentin | 25 | |
| Overall Study | COMPLETED | Placebo | 24 | |
| Overall Study | NOT COMPLETED | Gabapentin | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 2 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Depressed level of consciousness | Nervous system disorders | Gabapentin | 5 | 25 | 5 |
| other | Depressed level of consciousness | Nervous system disorders | Placebo | 5 | 24 | 6 |
| other | Anxiety | Psychiatric disorders | Gabapentin | 1 | 25 | 1 |
| other | Anxiety | Psychiatric disorders | Placebo | 0 | 24 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gabapentin | 0 | 25 |
| Total, all-cause mortality | Placebo | 0 | 24 |
| Total, other adverse events | Gabapentin | 5 | 25 |
| Total, other adverse events | Placebo | 5 | 24 |
| Total, serious adverse events | Gabapentin | 0 | 25 |
| Total, serious adverse events | Placebo | 0 | 24 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Gabapentin vs Placebo: deaths from any cause | Trial comparisons |
| Gabapentin vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01506453
GET https://conductscience.org/api/trials/v1/NCT01506453/results?page=2