Text Size

Study of Sulfasalazine in Treating Painful Diabetic Neuropathy

This study is currently recruiting participants.
Verified May 2013 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Brian Wainger, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01667029
First received: August 14, 2012
Last updated: May 9, 2013
Last verified: May 2013
History of Changes
  Purpose

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 diabetic peripheral neuropathy.


Condition Intervention Phase
Painful Diabetic Neuropathy
 Drug: Sulfasalazine
Drug: placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Single-center, Randomized, Double-blind Clinical Study to Evaluate the Effect of Sulfasalazine on Painful Diabetic Neuropathy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • pain score [ Time Frame: second week of two week treatment period ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Will be assessed by the Beck Depression Inventory metric

  • Overall Improvement [ Time Frame: Will be assessed at end of two week treatment period ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Assessed using description as "none, mild, moderate, or severe"

  • Breakthrough Treatment [ Time Frame: Assessed during two week treatment period ] [ Designated as safety issue: No ]
    Number of times breakthrough pain medication was taken


Estimated Enrollment: 55
Study Start Date: May 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HgbA1c between 6.5 and 11
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01667029

Contacts
Contact: Jared Beaumont, BA 617-726-5186 jbeaumont@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Jared Beaumont, BA     617-726-5186        
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Brian J Wainger, MD, PhD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Brian Wainger, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01667029     History of Changes
Other Study ID Numbers: 2012-p-001443
Study First Received: August 14, 2012
Last Updated: May 9, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetic Neuropathies
Pain
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Signs and Symptoms
Poisoning
 Substance-Related Disorders
Sulfasalazine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Anti-Infective Agents
Gastrointestinal Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013