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NCT00088296 · ClinicalTrials.gov registry record · Phase 2
Effects of Osteoarthritis Pain, Morphine, and Placebo on Neuroendocrine Function in Men
A Phase 2 study, sponsored by National Center for Complementary and Integrative Health (NCCIH).
- Completed
- Registry status
- Phase 2
- Development phase
- 72
- Enrollment target
NCT00088296 is a Phase 2 study that has completed, run by National Center for Complementary and Integrative Health (NCCIH). The registered enrollment target is 72 participants.
The verdict
NCT00088296, a Phase 2 study, has completed, sponsored by National Center for Complementary and Integrative Health (NCCIH).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 72 participants
- Enrollment target
Study Summary
This study will examine the effects of morphine on leuteinizing hormone, testosterone, adrenocorticotropic hormone and cortisol in men. The use of long-term opioids, such as morphine, to treat patients with pain is increasing, despite a dearth of information about their effects on hormones. The study will also look at the effect of chronic pain on these hormone levels and the effect of placebo on pain. Men between 30 and 65 years of age who have had moderate to severe chronic pain due to osteoarthritis for at least 3 months and healthy, pain-free men in the same age range may be eligible for this study. Patients taking an opioid-based medication such as percocet, vicodin, or morphine for pain relief, as well as patients who are not taking opioids, may participate. Candidates are screened with a medical history, physical examination, blood tests, including a blood test to look for possible "pain genes," electrocardiogram, x-ray, and questionnaires that assess the impact of pain on functional level and psychological well being. This is a four-part study. Healthy volunteers and patients who are taking opioids for their arthritis pain end their participation after Part I; those who are not taking opioids continue with Parts II, III, and IV, as follows: Part I: Participants are admitted to the NIH Clinical Center at 4 p.m. for an overnight stay. At 6 p.m. a catheter (plastic tube) is placed in a vein in the forearm and remains in place throughout the night. Blood samples of 3 cc's each (less than a teaspoon) are collected through the catheter every 20 minutes for 12 hours, from 8 p.m. until 8 a.m. Participants also collect their urine starting from 8 a.m. on the morning of hospital admission and continue the collection throughout their 24-hour hospital stay. Patients are discharged at the completion of the blood sampling. Part II: Patients are randomly assigned to take morphine (MS Contin), placebo, or standard treatment, which consists of anti-inflammatory medicatio
Interventions
- PROCEDURE Blood Draw
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2004-07-13 |
| Est. Completion | 2007-10-18 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00088296
The ClinicalTrials.gov registry entry for NCT00088296 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Center for Complementary and Integrative Health (NCCIH), which has 203 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Blood Draw is the first listed.
NCT00088296 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00088296 about?
NCT00088296 is a clinical study titled "Effects of Osteoarthritis Pain, Morphine, and Placebo on Neuroendocrine Function in Men". This study will examine the effects of morphine on leuteinizing hormone, testosterone, adrenocorticotropic hormone and cortisol in men. The use of long-term opioids, such as morphine, to treat patients with pain is increasing, despite a dearth of information about their effects on hormones. The stud...
What is the current status of trial NCT00088296?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 72 participants. The study started on 2004-07-13. Estimated completion is 2007-10-18.
What interventions are being tested in trial NCT00088296?
The interventions under investigation include: Blood Draw (PROCEDURE).
Who is sponsoring clinical trial NCT00088296?
This trial is sponsored by National Center for Complementary and Integrative Health (NCCIH), which has 203 total clinical trials registered on ClinicalTrials.gov.
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