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Study of Sulfasalazine in Treating Painful Neuropathy

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2016 by Brian Wainger, Massachusetts General Hospital
Information provided by (Responsible Party):
Brian Wainger, Massachusetts General Hospital Identifier:
First received: August 14, 2012
Last updated: July 12, 2016
Last verified: July 2016
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 Intervention Phase
Painful Neuropathy Drug: Sulfasalazine Drug: placebo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Brian Wainger, Massachusetts General Hospital:

Primary Outcome Measures:
  • 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:
  • 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

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

  • 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

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

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

Estimated Enrollment: 55
Study Start Date: May 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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
  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 identifier: 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
  More Information

Responsible Party: Brian Wainger, Principal Investigator, Massachusetts General Hospital Identifier: NCT01667029     History of Changes
Other Study ID Numbers: 2012-p-001443
Study First Received: August 14, 2012
Last Updated: July 12, 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 processed this record on September 21, 2017