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NCT01391858 · ClinicalTrials.gov registry record · Phase 3
Postoperative Pain and Morphine Consumption After Mastectomy - Lyrica
A Phase 3 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 80
- Enrollment target
NCT01391858 is a Phase 3 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 80 participants.
The verdict
NCT01391858, a Phase 3 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 80 participants
- Enrollment target
Study Summary
This study will compare the effects of oral pregabalin with placebo on postoperative pain and morphine usage after mastectomy. Pregabalin is an anticonvulsant agent approved by the United States Food and Drug Administration (FDA) for the treatment of neuropathic pain associated with post-herpetic neuralgia and diabetic neuropathy. Women 18-70 years of age, undergoing unilateral modified mastectomy or lumpectomy with axillary node dissection will be recruited to participate in the study. Patients unable to cooperative, those that have known allergy to pregabalin or morphine and a history of drug or alcohol abuse, chronic pain, history of daily intake of analgesics or steroids, or impaired kidney function will all be excluded from the study. A pregnancy test will also be performed to exclude pregnant women from the study. Oral pregabalin 300 mg (or placebo) will be administered to patients 1-2 hours before surgery followed by 150 mg 12 hours later. Thereafter, 150 mg of oral pregabalin (or placebo) will be administered twice daily until day 14. Whether a patient receives pregabalin or placebo will be decided based on a process similar to tossing a coin. Patients will receive a standard general anesthetic for their operation and will receive intravenous patient-controlled analgesia (PCA) morphine for pain in the immediate postoperative period. Oral opioids will be administered after discontinuation of the PCA. Subjects will be visited after the operation while in the hospital and intermittently for three months at the outpatient clinic after discharge from the hospital. Subjects will be asked to return remaining study drug/empty container when they are at the hospital for their 2 week follow up visit. Potential adverse effects of pregabalin include dizziness, somnolence, peripheral edema, weight gain, headache, dry mouth, blurry vision, and ataxia. The incidence of these side effects occurring ranges variously between 1 and 25%. Investigators will closely monitor
Interventions
- DRUG lyrica
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2006-12 |
| Est. Completion | 2013-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01391858
The ClinicalTrials.gov registry entry for NCT01391858 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which lyrica is the first listed.
NCT01391858 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01391858 about?
NCT01391858 is a clinical study titled "Postoperative Pain and Morphine Consumption After Mastectomy - Lyrica". This study will compare the effects of oral pregabalin with placebo on postoperative pain and morphine usage after mastectomy. Pregabalin is an anticonvulsant agent approved by the United States Food and Drug Administration (FDA) for the treatment of neuropathic pain associated with post-herpetic n...
What is the current status of trial NCT01391858?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 80 participants. The study started on 2006-12. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01391858?
The interventions under investigation include: lyrica (DRUG).
Who is sponsoring clinical trial NCT01391858?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
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