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NCT00009672 · ClinicalTrials.gov registry record · Phase 2
Pain Treatment for Sciatica
A Phase 2 study of Sciatica and Radiculopathy, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- Completed
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT00009672 is a Phase 2 study of Sciatica and Radiculopathy that has completed, run by National Institute of Dental and Craniofacial Research (NIDCR). The registered enrollment target is 80 participants, roughly in line with the 74-participant average among 6 other Sciatica trials with a reported enrollment target. The trial reports 1 study location across 1 state.
The verdict
NCT00009672, a Phase 2 study of Sciatica and Radiculopathy, has completed, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will test the effectiveness of two drugs-nortriptyline and MS Contin (a type of morphine)-to treat pain caused by lumbar radiculopathy, or sciatica. Sciatica results from damage to the lumbar nerve roots, typically causing back pain and sharp, shooting pain down one or both legs. Although sciatica is common, there are no good treatments for it. Tricyclic antidepressants, such as nortriptyline, and opioids, such as morphine, have been effective in treating other kinds of pain from nerve damage. Patients between 18 and 65 years of age who have had sciatica pain daily for at least 3 months may be eligible for this study. Participants will provide a medical history and occupational and other social information. They will undergo a neurological examination, routine blood tests and an electrocardiogram and will fill out three questionnaires providing information on daily functioning and psychological well-being. This "cross-over" study consists of several parts, including a baseline study and four different treatment regimens. During each part, patients keep a daily log in which they rate their pain, record other procedures they undergo, such as injections and manipulations, and record medication side effects. In the first week of the study, patients remain on their current medications. Any antidepressants or opioids are stopped gradually before starting the drug trials. After the first week, patients go through the following four drug trials in random order: 1. Nortriptyline and inert placebo-Patients take nortriptyline in doses ranging from 25 mg. to 100 mg. and an inert placebo for morphine. (An inert placebo is a dummy pill; it looks like the test drug but has no active ingredient.) 2. MS Contin (morphine) and inert placebo-Patients take MS Contin in doses ranging from 30 mg. to 90 mg. and an inert placebo for nortriptyline. 3. Nortriptyline and MS Contin-Patients take MS Contin and nortriptyline in the same dose ranges as for each drug alone. 4. Activ
Conditions Studied
Interventions
- DRUG Morphine
- DRUG Nortriptyline
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2001-01-30 |
| Est. Completion | 2006-12-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00009672
The ClinicalTrials.gov registry entry for NCT00009672 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 74-participant average among 6 other Sciatica trials with a reported enrollment target. 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 2 conditions, with Sciatica appearing as the primary indexed condition, and to 2 interventions - of which Morphine is the first listed.
NCT00009672 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00009672 about?
NCT00009672 is a clinical study titled "Pain Treatment for Sciatica". This study will test the effectiveness of two drugs-nortriptyline and MS Contin (a type of morphine)-to treat pain caused by lumbar radiculopathy, or sciatica. Sciatica results from damage to the lumbar nerve roots, typically causing back pain and sharp, shooting pain down one or both legs. Although...
What is the current status of trial NCT00009672?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2001-01-30. Estimated completion is 2006-12-12.
What conditions does trial NCT00009672 study?
This clinical trial studies the following conditions: Sciatica, Radiculopathy.
What interventions are being tested in trial NCT00009672?
The interventions under investigation include: Morphine (DRUG), Nortriptyline (DRUG).
Who is sponsoring clinical trial NCT00009672?
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 NCT00009672 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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