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NCT00737737 · ClinicalTrials.gov registry record · Phase 4
Hormone Function in Men Treated for Pain With Opioids or Placebo
A Phase 4 study, sponsored by National Institute of Nursing Research (NINR).
- Completed
- Registry status
- Phase 4
- Development phase
- 8
- Enrollment target
NCT00737737 is a Phase 4 study that has completed, run by National Institute of Nursing Research (NINR). The registered enrollment target is 8 participants.
The verdict
NCT00737737, a Phase 4 study, has completed, sponsored by National Institute of Nursing Research (NINR).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 8 participants
- Enrollment target
Study Summary
This study will examine hormone function in men with osteoarthritis pain and how it is affected by opioid medication (such as Percocet, Vicodin, MS Contin and morphine) versus placebo. Men between 30 and 65 years of age who have had moderate to severe osteoarthritis joint pain at least 5 days a week over the past 3 months may be eligible for this study. Candidates are screened with a physical examination, x-rays, laboratory and other tests, and questionnaires about pain, mood and medical health. They are given a pain diary to complete for 2 weeks. Participants are admitted to the hospital for two 12 hour overnight stays, during each of which they provide a 24-hour urine collection and have a small blood sample drawn every 20 minutes for 12 hours (from 8:00 p.m. to 8:00 a.m.) through a catheter that remains in place in a vein. Blood pressure and pulse are monitored during this time. After the catheter is removed, subjects complete questionnaires about their pain, mood and activity. For the several weeks between the two hospitalizations, subjects take either an opioid medication or placebo, or standard medication such as motrin and naprosyn, according to random assignment to one of the three groups. All participants will be allowed to take anti-inflammatory medications and acetaminophen during this time as needed, but no other pain medications or treatments. They are monitored two or three times a week by telephone and complete a pain diary. After the second hospitalization, subjects are tapered off the study medication. After 2 to 4 weeks of stopping medication, they return for a final outpatient visit to review pain or other medical problems and to have blood drawn.
Interventions
- DRUG Placebo
- DRUG MS Contin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2008-08 |
| Est. Completion | 2014-04 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00737737
The ClinicalTrials.gov registry entry for NCT00737737 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 8 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 Placebo is the first listed.
NCT00737737 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00737737 about?
NCT00737737 is a clinical study titled "Hormone Function in Men Treated for Pain With Opioids or Placebo". This study will examine hormone function in men with osteoarthritis pain and how it is affected by opioid medication (such as Percocet, Vicodin, MS Contin and morphine) versus placebo. Men between 30 and 65 years of age who have had moderate to severe osteoarthritis joint pain at least 5 days a wee...
What is the current status of trial NCT00737737?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 8 participants. The study started on 2008-08. Estimated completion is 2014-04.
What interventions are being tested in trial NCT00737737?
The interventions under investigation include: Placebo (DRUG), MS Contin (DRUG).
Who is sponsoring clinical trial NCT00737737?
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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