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NCT00001956 · ClinicalTrials.gov registry record · Phase 2
Influence of Genetics in Pain Sensitivity
A Phase 2 study of Healthy and Pain, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- Completed
- Registry status
- Phase 2
- Development phase
- 800
- Enrollment target
- 1
- Study location
NCT00001956 is a Phase 2 study of Healthy and Pain that has completed, run by National Institute of Dental and Craniofacial Research (NIDCR). The registered enrollment target is 800 participants, above the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (24% higher). The trial reports 1 study location across 1 state.
The verdict
NCT00001956, a Phase 2 study of Healthy and Pain, has completed, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 800 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to learn more about the role of genetics in pain sensitivity. Pain perception varies widely among individuals, and information gained from this trial may lead to better methods of preventing and controlling pain. The study consists of two parts, described below. All enrollees will participate in part 1; patients needing oral surgery for removal of third molars may also participate in part 2. Normal volunteers, oral surgery patients, and family members of both groups may be eligible for this study. Part 1 -Sensitivity testing for hot and cold. Participants will rate their pain response to hot and cold stimuli on a scale from "no pain" to the "worst pain imaginable." Heat sensitivity is measured using a small probe placed on the skin for a few seconds. The hottest temperature tested may cause pain for a few seconds but will not produce a burn. Response to cold is measured by placing the hand in cold water for up to 3 minutes and occasionally flexing the fist. Participants will rate their pain level every 15 seconds. In addition to the testing, a blood sample will be drawn to examine for genes related to pain. Part 2 - Oral surgery. Patients will have their third molar removed under a local anesthetic (lidocaine) injected in the mouth and a sedative (Versed) given through a vein in the arm. A small tissue biopsy will be taken from the tissue over one of the third molars. Patients will stay in the clinic for up to 7 hours after surgery while the anesthetic wears off and will rate any pain they may have according to the rating scale used in Part 1 of the study. Pain medication (ketorolac, or Toradol) will be given when needed, and patients will complete pain questionnaires for 3 hours after the drug is given to rate its effectiveness. Patients will receive additional pain relievers, if needed. A second biopsy on the side opposite the first will be taken under local anesthetic to measure changes in chemical signals produced in response to t
Conditions Studied
Interventions
- PROCEDURE Blood draw
- PROCEDURE Tissue biopsy
- PROCEDURE Oral surgery
Study Locations (1)
Maryland
- National Institute of Dental And Craniofacial Research (NIDCR) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 800 participants |
| Start Date | 2000-01 |
| Est. Completion | 2005-02 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001956
The ClinicalTrials.gov registry entry for NCT00001956 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 800 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (24% higher). The listed sponsor is National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Healthy appearing as the primary indexed condition, and to 3 interventions - of which Blood draw is the first listed.
NCT00001956 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00001956 about?
NCT00001956 is a clinical study titled "Influence of Genetics in Pain Sensitivity". The purpose of this study is to learn more about the role of genetics in pain sensitivity. Pain perception varies widely among individuals, and information gained from this trial may lead to better methods of preventing and controlling pain. The study consists of two parts, described below. All enro...
What is the current status of trial NCT00001956?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 800 participants. The study started on 2000-01. Estimated completion is 2005-02.
What conditions does trial NCT00001956 study?
This clinical trial studies the following conditions: Healthy, Pain, Hyperalgesia.
What interventions are being tested in trial NCT00001956?
The interventions under investigation include: Blood draw (PROCEDURE), Tissue biopsy (PROCEDURE), Oral surgery (PROCEDURE).
Who is sponsoring clinical trial NCT00001956?
This trial is sponsored by National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001956 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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