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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 is a Phase 2 study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 90 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01954927
The ClinicalTrials.gov registry entry for NCT01954927 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01954927 reports 0 study locations.
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.
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