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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Ortho-McNeil, Inc.
Information provided by (Responsible Party):
Jianren Mao, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00505531
First received: July 19, 2007
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

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
Chronic Pain

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Estimated Enrollment: 93
Study Start Date: June 2007
Estimated Study Completion Date: December 2014
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects whose chronic pain is not well controlled on narcotic pain medicine.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00505531

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

Additional Information:
No publications provided

Responsible Party: Jianren Mao, MD, PhD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00505531     History of Changes
Other Study ID Numbers: 2007P 000025
Study First Received: July 19, 2007
Last Updated: July 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Pain

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

ClinicalTrials.gov processed this record on November 24, 2014