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NCT01393847 · ClinicalTrials.gov registry record

Nitric Oxide and Sickle Cell Pain

A clinical trial, sponsored by National Institute of Nursing Research (NINR).

Terminated
Registry status
12
Enrollment target

NCT01393847: Clinical Trial study, sponsored by National Institute of Nursing Research (NINR).

NCT01393847 is a clinical trial that was terminated before completion, run by National Institute of Nursing Research (NINR). The registered enrollment target is 12 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01393847 was terminated before completion, sponsored by National Institute of Nursing Research (NINR).

TERMINATED
Registry status
12 participants
Enrollment target

Study Summary

Background: \- Sickle cell disease often causes crises, with episodes of pain. Many people with sickle cell disease also have pain between crises. Inflammation is an important part of sickle cell pain. It may be related to levels of nitric oxide. Nitric oxide is a gas in the body that helps relax blood vessels and may be related to the pain from sickle cell disease. Researchers want to study the relationship between blood levels of nitric oxide and pain in people with sickle cell disease. Researchers also want to study how certain genes express themselves related to sickle cell pain. Objectives: \- To collect blood samples and other genetic expression information to study sickle cell pain and its relation to nitric oxide levels in the blood. Eligibility: * People at least 18 years of age who have sickle cell disease. * Healthy volunteers at least 18 years of age. Design: * This study requires a screening visit and four study visits scheduled 1 week apart. Each visit will last about 1 hour. * Participants will be screened with a medical history and physical exam. They will complete questionnaires about pain levels (if any). They will also provide blood samples for genetic and other testing. * Participants will have a breath test to see how much nitric oxide they exhale. They will also have a test of their ability to detect small changes in temperature and touch. * Participants will keep a diary to record daily pain levels and pain medicines taken. They will write down what they eat to track foods that contain nitrates (such as meats like ham and bacon and vegetables like beets and spinach). * At each of the four study visit, participants will bring the pain diary, provide blood samples, and have breath nitric oxide tests.

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2011-06-17
Est. Completion 2013-12-05

Why NCT01393847 stopped before completion

NCT01393847 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 12 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT01393847 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01393847 about?

NCT01393847 is a clinical study titled "Nitric Oxide and Sickle Cell Pain". Background: \- Sickle cell disease often causes crises, with episodes of pain. Many people with sickle cell disease also have pain between crises. Inflammation is an important part of sickle cell pain. It may be related to levels of nitric oxide. Nitric oxide is a gas in the body that helps relax b...

What is the current status of trial NCT01393847?

This trial is currently terminated. The enrollment target is 12 participants. The study started on 2011-06-17. Estimated completion is 2013-12-05.

Who is sponsoring clinical trial NCT01393847?

This trial is sponsored by National Institute of Nursing Research (NINR), which has 46 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01393847, the US trial registry maintained by the National Library of Medicine. NCT01393847 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.