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NCT00115752 · ClinicalTrials.gov registry record · Phase 2
Genetic Basis For Variation In NSAID Analgesia In A Clinical Model Of Acute Pain
A Phase 2 study, sponsored by National Institute of Nursing Research (NINR).
- Completed
- Registry status
- Phase 2
- Development phase
- 96
- Enrollment target
NCT00115752 is a Phase 2 study that has completed, run by National Institute of Nursing Research (NINR). The registered enrollment target is 96 participants.
The verdict
NCT00115752, a Phase 2 study, has completed, sponsored by National Institute of Nursing Research (NINR).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 96 participants
- Enrollment target
Study Summary
This study will evaluate how genetic makeup contributes to the variation in people regarding their sensitivity to and experience of pain. Scientists believe that differences in information found in genes may explain why an analgesic drug, that is, one that treats pain, works effectively for some people but not for others. The study will explore pain that is acute (fast and short period). Knowledge gained from this ongoing study may permit development of an individualized analgesic drug prescription. Patients ages 16 to 35 who are in good health and have been referred for removal of impacted wisdom teeth; who are not allergic to aspirin or other nonsteroidal anti-inflammatory drugs (known as NSAIDs), sulfites, or certain anesthetics; who are not pregnant or nursing; and who are willing to have a biopsy before and after dental surgery are eligible for this study. Patients will come to the clinic for one test visit and one treatment visit. During the first visit, a questionnaire will evaluate patients' psychological state, including mood and depression. There will be a clinical examination of their wisdom teeth. A blood sample of 10 milliliters (about 0.4 ounces) will be collected from the forearm to provide DNA material containing genes stored in cells. The primary genetic analysis will be done at NIH, although the DNA collected might also be sent to a laboratory outside NIH. DNA samples will be coded so that names of patients cannot be traced. During the second visit, two of the patients' lower wisdom teeth will be removed. Patients will be given a local anesthetic in the mouth and a sedative given through a vein in the arm. While the mouth is numb, a small piece of tissue will be removed from inside the cheek, near the wisdom tooth. It is the first biopsy. After the two wisdom teeth are removed, a small piece of tubing will be placed into both sides of the mouth where the teeth were removed. Every 20 minutes, for the next 3 hours, the researchers will collect inf
Interventions
- DRUG Valdecoxib
- DRUG COX Inhibitor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2005-06-20 |
| Est. Completion | 2006-10-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00115752
The ClinicalTrials.gov registry entry for NCT00115752 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Nursing Research (NINR), which has 46 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Valdecoxib is the first listed.
NCT00115752 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00115752 about?
NCT00115752 is a clinical study titled "Genetic Basis For Variation In NSAID Analgesia In A Clinical Model Of Acute Pain". This study will evaluate how genetic makeup contributes to the variation in people regarding their sensitivity to and experience of pain. Scientists believe that differences in information found in genes may explain why an analgesic drug, that is, one that treats pain, works effectively for some peo...
What is the current status of trial NCT00115752?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 96 participants. The study started on 2005-06-20. Estimated completion is 2006-10-04.
What interventions are being tested in trial NCT00115752?
The interventions under investigation include: Valdecoxib (DRUG), COX Inhibitor (DRUG).
Who is sponsoring clinical trial NCT00115752?
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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