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NCT01954927 · ClinicalTrials.gov registry record · Phase 2
Pain Management in Children and Young Adults With Sickle Cell Disease
A Phase 2 study, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
NCT01954927: Completed Phase 2 study, sponsored by St. Jude Children's Research Hospital.
NCT01954927 is a Phase 2 study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 90 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01954927, a Phase 2 study, has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 90 participants
- Enrollment target
Study Summary
This is a phase II double-blind placebo-controlled clinical trial evaluating the effect of gabapentin when added to standard pain management for patients with sickle cell disease experiencing acute pain crisis in the ambulatory care setting. Sickle cell pain is different for every patient. Some patients get complete relief from routine pain medicines, and others need more time or more doses of pain medicines before the pain goes away completely. It is known that humans have many types of pain, including something called neuropathic pain. Neuropathic pain in other conditions (such as diabetes) has been treated successfully with a medicine called gabapentin. The investigators in this study suspect that some sickle cell pain is a combination of pain types. They would like to see if adding gabapentin to the usual pain medicines makes pain go away faster or more completely. Primary Objective: * To assess the analgesic efficacy of gabapentin vs. placebo for pain during vaso-occlusive crisis (VOC) in participants with sickle cell disease (SCD). A response to study drug will be defined by a decrease in pain score of ≥ 33% between presentation to the acute care setting and assessment at 3 hours post administration of study drug. Secondary Objective: * To compare the total morphine equivalent dose (mg/kg) used to control pain during VOC between presentation to the acute care setting and assessment at 3 hours post administration of study drug in the gabapentin vs. placebo groups.
Primary Outcome
Pain scales used are the numerical rating system, the Faces Pain Scale, and the Faces, Legs, Arms, Cry and Consolability (FLACC) pain scale (for patients 7 years or older, ages 4-6 years, or less than 4 years, respectively). For each patient, if the reduction of the pain scores (0=no pain and 10=worst possible pain) between presentation to the acute care setting and 3 hours post administration of study drug is 33% or greater, then this patient will be defined as having a successful intervention.
Interventions
- DRUG Placebo
- DRUG Gabapentin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2013-10-07 |
| Est. Completion | 2018-01-03 |
| Phase | Phase 2 |
What the finished NCT01954927 record still lists
NCT01954927 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01954927 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01954927 about?
NCT01954927 is a clinical study titled "Pain Management in Children and Young Adults With Sickle Cell Disease". This is a phase II double-blind placebo-controlled clinical trial evaluating the effect of gabapentin when added to standard pain management for patients with sickle cell disease experiencing acute pain crisis in the ambulatory care setting. Sickle cell pain is different for every patient. Some pat...
What is the current status of trial NCT01954927?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2013-10-07. Estimated completion is 2018-01-03.
What interventions are being tested in trial NCT01954927?
The interventions under investigation include: Placebo (DRUG), Gabapentin (DRUG).
Who is sponsoring clinical trial NCT01954927?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01954927's enrollment target sits among peer trials
90 772nd of 2000 higher than 1,199 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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