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Pain Study to See if Ultram ER Will Provide Relief to Subjects Whose Pain is Not Well Controlled by Narcotics

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ClinicalTrials.gov Identifier: NCT00505531
Recruitment Status : Unknown
Verified July 2014 by Jianren Mao, MD, PhD, Massachusetts General Hospital.
Recruitment status was:  Active, not recruiting
First Posted : July 23, 2007
Last Update Posted : July 3, 2014
Ortho-McNeil, Inc.
Information provided by (Responsible Party):
Jianren Mao, MD, PhD, Massachusetts General Hospital

Brief Summary:
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.

Condition or disease
Chronic Pain

Detailed Description:
The study consists of 6 visits over 6 weeks. Study testing includes: physical exam, urine testing, questionnaires and non-invasive (no needles) nerve testing using cold/heat sensations. Compensation and some parking reimbursement provided.

Study Type : Observational
Estimated Enrollment : 93 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Pain Study to See if Ultram ER Will Provide Relief to Subjects Whose Pain is Not Well Controlled by Narcotics
Study Start Date : June 2007
Primary Completion Date : December 2007
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects whose chronic pain is not well controlled on narcotic pain medicine.

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 the last six months. We consider eight weeks and six months as the minimal time period that must have elapsed after neuraxial injection and lumbar sympathetic block, respectively, in order to minimize the possible influence from a previous interventional procedure.
  4. Subject has a pending litigation related to his/her chronic pain condition.
  5. Subject has a history of or current seizure disorder.
  6. Subject has a history of severe allergic reaction to Tramadol ER or other opioid medications.
  7. Subject has a major psychiatric disorder (major depression; bipolar disorder; schizophrenia; anxiety disorder; psychotic disorders; eating disorders; alcohol or drug dependence; attention deficit hyperactivity disorder); subject with any known history of such conditions also will be excluded.
  8. Subject has severe renal impairment or severe hepatic impairment.
  9. Subject is using illicit drugs detected through the urine toxicology screen.
  10. Subject is pregnant or lactating.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00505531

United States, Massachusetts
MGH Center for Translational Pain Research
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Ortho-McNeil, Inc.
Principal Investigator: Jianren Mao, M.D. Massachusetts General Hospital

Additional Information:
Responsible Party: Jianren Mao, MD, PhD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00505531     History of Changes
Other Study ID Numbers: 2007P 000025
First Posted: July 23, 2007    Key Record Dates
Last Update Posted: July 3, 2014
Last Verified: July 2014

Keywords provided by Jianren Mao, MD, PhD, Massachusetts General Hospital:

Additional relevant MeSH terms:
Chronic Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents