Study of Sulfasalazine in Treating Painful Neuropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01667029
Recruitment Status : Recruiting
First Posted : August 17, 2012
Last Update Posted : July 14, 2016
Information provided by (Responsible Party):
Brian Wainger, Massachusetts General Hospital

Brief Summary:
The investigators hypothesize that sulfasalazine, an FDA-approved medication for rheumatoid arthritis and ulcerative colitis, may be beneficial in neuropathic pain conditions. In this study, the investigators will evaluate whether sulfasalazine improves pain due to painful peripheral neuropathy.

Condition or disease Intervention/treatment Phase
Painful Neuropathy Drug: Sulfasalazine Drug: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Single-center, Randomized, Double-blind Clinical Study to Evaluate the Effect of Sulfasalazine on Painful Neuropathy
Study Start Date : May 2013
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: sulfasalazine
1 g oral twice daily for 2 weeks
Drug: Sulfasalazine
Placebo Comparator: placebo
oral placebo pill twice daily for two weeks.
Drug: placebo

Primary Outcome Measures :
  1. pain score [ Time Frame: second week of two week treatment period ]
    Average pain score will be the average of daily pain scores (0-10) recorded by the subject during the second week of the two week treatment period.

Secondary Outcome Measures :
  1. Physical Functioning Score [ Time Frame: Assessed at end of two week treatment period ]
    Will be assessed using the Brief Pain Inventory Interference and Euroquality of Life metrics

  2. Emotional Functioning [ Time Frame: Assessed at end of two week treatment period ]
    Will be assessed by the Beck Depression Inventory metric

  3. Overall Improvement [ Time Frame: Will be assessed at end of two week treatment period ]
    Will be assessed using the Patient Global Impression of Change metric

  4. Categorical rating of pain intensity [ Time Frame: Assessed at end of two week treatment period ]
    Assessed using description as "none, mild, moderate, or severe"

  5. Breakthrough Treatment [ Time Frame: Assessed during two week treatment period ]
    Number of times breakthrough pain medication was taken

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Painful neuropathy
  • Michigan Neuropathy Screening Instrument score of 3 or greater
  • no obvious alternative explanation for neuropathy
  • average baseline pain > 4/10

Exclusion Criteria:

  • other severe pain
  • anticipated difficulty weaning off medications
  • past or current psychiatric disorder as determined by Mini International Neuropsychiatric Interview
  • medical contraindication to sulfasalazine
  • not proficient in English (due to heavy use of questionaires)
  • pregnant or breast feeding women

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 identifier (NCT number): NCT01667029

Contact: Anthony Lever, BA 617 726-5186

United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Anthony Lever, BA    617-726-5186      
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: Brian J Wainger, MD, PhD Massachusetts General Hospital

Responsible Party: Brian Wainger, Principal Investigator, Massachusetts General Hospital Identifier: NCT01667029     History of Changes
Other Study ID Numbers: 2012-p-001443
First Posted: August 17, 2012    Key Record Dates
Last Update Posted: July 14, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Anti-Infective Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents