Pain Study to See if Ultram ER Will Provide Relief to Subjects Whose Pain is Not Well Controlled by Narcotics
TerminatedNCT00505531
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The Massachusetts General Hospital Center for Translational Pain Research is conducting a research study to see if Ultram ER, an FDA-approved pain medication, would be helpful in providing pain relief in subjects whose chronic pain is not well controlled on narcotic pain medicine.
Study details
- Official title
- Pain Study to See if Ultram ER Will Provide Relief to Subjects Whose Pain is Not Well Controlled by Narcotics
- Conditions
- Interventions
- Drug: Tramadol Extended Release Oral Capsule
- Drug: Benadryl
- Sponsor
- Massachusetts General Hospital
- Collaborators
- Ortho-McNeil, Inc.
- Start date
- 2007-06
- Primary completion
- 2007-12
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Subject will be between ages 18 to 65 years in all three groups. 2. Subject has NOT been on Tramadol or Tramadol ER for at least one month. 3. Subject has NOT been on tricyclic antidepressants, serotonin, norepinephrine, or mixed serotonin/norepinephrine reuptake inhibitors (SSRI/SNRI), or muscle relaxant with potential action as an SSRI or SNRI (e.g., Flexeril) for at least one month. Subject has not been on monoamine oxidase inhibitors in the past 14 days. 4. Subjects should have had a stable pain condition (e.g., axial low back pain as listed below in item # 5-7) for at least three months. This requirement is set in order to avoid clinical uncertainty from an unstable pain condition and to minimize the study variation. 5. Axial low back pain refers to pain conditions resulting from myofascial disorder, lumbar facet joint disease, discogenic disease, and postlaminectomy syndrome. Patients with neurological signs (weakness or numbness) will not be included in the study because of potential confounding effects on the QST assessment of pain threshold and pain tolerance. 6. Headaches refer to migraine, tension, or cluster headache, cervicogenic pain (e.g., facet joint disease, myofascial pain), and trigeminal neuralgia. However, patients with neurological diseases including multiple sclerosis, amyotrophic lateral sclerosis, and stroke will not be included due to possible neurological deficits that may confound the QST assessment. 7. Abdominal and pelvic pain refers to pain from abdominal and/or pelvic organs (e.g., chronic pancreatitis, endometriosis). 8. Subject is willing to have his/her opioid dose tapered. 9. Female subjects of childbearing potential must have a negative urine pregnancy test at the initial visit. Exclusion Criteria: 1. Subject has sensory deficits at the sites of QST. Sensory deficits refer to such changes resulting from neurological diseases or medical conditions causing peripheral polyneuropathy and sensory changes, which include but are not limited to diabetes, alcoholic neuropathy, AIDS neuropathy, thyroid disease, severe liver or kidney disorders. 2. Subject has scar tissue, infection, or acute injury at the sites of QST. 3. Subject has had interventional procedures that may alter the results of QST. Such procedures include neuroablation (chemical or electrothermal) at any time, neuraxial (e.g., epidural) or local anesthetic block within the last eight weeks, and lumbar sympathetic or hypogastric block within …
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00505531