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NCT01441141 · ClinicalTrials.gov registry record
Genetics and Pain Severity in Sickle Cell Disease
A clinical trial, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- 67
- Enrollment target
NCT01441141: Completed study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT01441141 is a clinical trial that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 67 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01441141 has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- 67 participants
- Enrollment target
Study Summary
Background: \- Pain is the most common symptom of sickle cell disease. Episodes of severe sickle cell pain are known as "crises." High rates of pain crises are associated with a higher risk of early death. Some people with sickle cell disease have many severe pain crises while others experience fewer crises. This difference in pain crisis may be caused by sensitivity to pain. People with high sensitivity to pain may have more pain crises. Many factors, including a person's genetic makeup, determine sensitivity to pain. Comparing genetic information from people with sickle cell disease and healthy volunteers may provide more information on pain and sickle cell disease. Objectives: \- To study genetics and pain sensitivity in sickle cell disease. Eligibility: * African or African American individuals at least 18 years of age with sickle cell disease. * Healthy African or African American volunteers at least 18 years of age. Design: * Participants will be screened with a medical history and physical exam. They will also provide blood and urine samples. * Participants will have the following tests: * Quantitative sensory testing to measure sensitivity to pressure, heat, cold, and mechanical pain. * EndoPat test to measure blood vessel function and reaction. * Questionnaires about mood, evidence of depression, pain, quality of sleep, and sleep disturbances. * Measures of daily pain, whether or not related to sickle cell disease. * After the first visit, those in the study will have monthly study visits for 6 months. The above tests will be repeated at these visits.
Primary Outcome
lower pain threshold in SCD than in non-SCD controls
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2012-06-17 |
| Est. Completion | 2020-12-09 |
What the finished NCT01441141 record still lists
NCT01441141 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 67 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01441141 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01441141 about?
NCT01441141 is a clinical study titled "Genetics and Pain Severity in Sickle Cell Disease". Background: \- Pain is the most common symptom of sickle cell disease. Episodes of severe sickle cell pain are known as "crises." High rates of pain crises are associated with a higher risk of early death. Some people with sickle cell disease have many severe pain crises while others experience few...
What is the current status of trial NCT01441141?
This trial is currently completed. The enrollment target is 67 participants. The study started on 2012-06-17. Estimated completion is 2020-12-09.
Who is sponsoring clinical trial NCT01441141?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
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