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NCT00121563 · ClinicalTrials.gov registry record · Phase 2
Evaluation of a TNF-Alpha Modulator for Clinical and Molecular Indicators of Analgesic Effect
A Phase 2 study, sponsored by National Institute of Nursing Research (NINR).
- Completed
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
NCT00121563 is a Phase 2 study that has completed, run by National Institute of Nursing Research (NINR). The registered enrollment target is 90 participants.
The verdict
NCT00121563, a Phase 2 study, has completed, sponsored by National Institute of Nursing Research (NINR).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 90 participants
- Enrollment target
Study Summary
This study will evaluate the role of thalidomide, a tumor necrosis factor (TNF)-alpha modulator, on severe inflammation and relief of pain following extraction of wisdom teeth. TNFs are substances that affect the pathways of pain. This study involves an experimental group in which patients will be given thalidomide or a placebo (an inactive substance); a negative control group receiving the medication diazepam or a placebo; and a positive control group receiving diazepam or ibuprofen. Patients who are males ages 16 to 35, who are not allergic to aspirin or other nonsteroidal anti-inflammatory drugs (known as NSAIDs), sulfites, or certain anesthetics, and who in good health may be eligible for this study. Females are not eligible, owing to the risks that thalidomide presents to unborn children. To minimize the risk of fetal malformations, male patients who participate must use a condom during sexual intercourse for 4 weeks following the study and must not donate blood for 4 weeks. The medications used in the study will be given 1 hour before surgery. Then after the wisdom teeth are removed, a small piece of tubing will be placed into both sides of the patient's mouth where the teeth were removed. Every 20 minutes, for the next 6 hours, the researchers will collect inflammatory fluid from the tubing, to measure for changes in anti-inflammatory action. If they request pain relievers, patients will receive the medication ketorolac (Toradol), used for short-term treatment of moderately severe acute pain. Side effects of thalidomide include fatigue, dizziness, and rash. The use of ibuprofen and ketorolac may include the risk of gastrointestinal ulcers and bleeding. Diazepam can cause involuntary muscle movements and drowsiness, as well as dizziness lasting for up to 24 hours after it has been used as sedation. Patients will be instructed not to try to walk alone or to try to drive a vehicle during that period. Other risks related to participation in this study include t
Interventions
- DRUG Thalidomide, Ibuprofen or Diazepam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2005-07 |
| Est. Completion | 2006-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00121563
The ClinicalTrials.gov registry entry for NCT00121563 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 National Institute of Nursing Research (NINR), which has 46 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Thalidomide, Ibuprofen or Diazepam is the first listed.
NCT00121563 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00121563 about?
NCT00121563 is a clinical study titled "Evaluation of a TNF-Alpha Modulator for Clinical and Molecular Indicators of Analgesic Effect". This study will evaluate the role of thalidomide, a tumor necrosis factor (TNF)-alpha modulator, on severe inflammation and relief of pain following extraction of wisdom teeth. TNFs are substances that affect the pathways of pain. This study involves an experimental group in which patients will be g...
What is the current status of trial NCT00121563?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2005-07. Estimated completion is 2006-02.
What interventions are being tested in trial NCT00121563?
The interventions under investigation include: Thalidomide, Ibuprofen or Diazepam (DRUG).
Who is sponsoring clinical trial NCT00121563?
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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