Study of Sulfasalazine in Treating Painful Neuropathy

A Single-center, Randomized, Double-blind Clinical Study to Evaluate the Effect of Sulfasalazine on Painful Neuropathy

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.

Study Overview

• Status: Terminated
• Conditions: Painful Neuropathy
• Intervention / Treatment: Drug: placebo; Drug: Sulfasalazine

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score (First Treatment Period)	Average pain score will be the average of daily pain scores (0-10) recorded by the subject in a pain diary during the second week of the two week treatment period. Higher scores are worse (0=no pain, 10=pain as bad as you can imagine).	second week of two week treatment period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score (Using the Crossover Comparison Structure of the Study)	Average pain score will be the average of daily pain scores (0-10) recorded by the subject in a pain diary during the second week of the two week treatment period. Higher scores are worse (0=no pain, 10=pain as bad as you can imagine).	Assessed at end of two week treatment period
Number of Patients With >=50% Pain Reduction (First Treatment Period)	Average pain score will be the average of daily pain scores (0-10) recorded by the subject in a pain diary at baseline and during the second week of the two week treatment period. Higher scores are worse (0=no pain, 10=pain as bad as you can imagine). Percent pain reduction will be calculated from BL to end of treatment period 1 (2 weeks), based on average pain scores at each time point.	second week of two week treatment period
Number of Patients With >=50% Pain Reduction (Using the Crossover Comparison Structure of the Study)	Average pain score will be the average of daily pain scores (0-10) recorded by the subject in a pain diary during baseline and the second week of each of the two week treatment periods. Higher scores are worse (0=no pain, 10=pain as bad as you can imagine). Percent pain reduction will be calculated from BL to end of treatment period 1 (2 weeks) and from end of treatment period 1 to end of treatment period 2 (2 weeks), based on average pain scores at each time point.	Assessed at end of two week treatment period
Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (First Treatment Period Only)	The BPI interference items are general activity, mood, walking ability, normal work (including housework), relations with other people, sleep, and enjoyment of life. The seven items are rated from 0 (pain does not interfere) to 10 (pain completely interferes).	Assessed at end of two week treatment period
Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only)	The EQ-5D physical functioning items are mobility self-care, and usual activities. These three items are rated from 1 (no problems) to 5 (unable).	Assessed at end of two week treatment period
Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (Using the Crossover Comparison Structure of the Study)	The BPI interference items are general activity, mood, walking ability, normal work (including housework), relations with other people, sleep, and enjoyment of life. The seven items are rated from 0 (pain does not interfere) to 10 (pain completely interferes).	Assessed at end of two week treatment period
Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study)	The EQ-5D physical functioning items are mobility self-care, and usual activities. These three items are rated from 1 (no problems) to 5 (unable).	Assessed at end of two week treatment period
Emotional Functioning (First Treatment Period Only)	Will be assessed by the Beck Depression Inventory (BDI) total score. The BDI has 21 items, each scored 0-3. Higher values are worse. The total score is the sum of the 21 items and ranges from 0-63.	Assessed at end of two week treatment period
Emotional Functioning (Using the Crossover Comparison Structure of the Study)	Will be assessed by the Beck Depression Inventory (BDI) total score. The BDI has 21 items, each scored 0-3. Higher values are worse. The total score is the sum of the 21 items and ranges from 0-63.	Assessed at end of two week treatment period
Overall Improvement (First Treatment Period Only)	The Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment. Item 1 is as follows: Since beginning treatment at this clinic, how would you describe the change (if any) in ACTIVITY LIMITATIONS, SYMPTOMS, EMOTIONS, and OVERALL QUALITY OF LIFE, related to your painful condition? (tick ONE box) (1=No change (or condition has gotten worse), 2=Almost the same, hardly any change at all, 3=A little better, but no noticeable change, 4=Somewhat better, but the change has not made any real difference, 5=Moderately better, and a slight but noticeable change, 6=Better, and a definite improvement that has made a real and worthwhile difference, 7=A great deal better, and a considerable improvement that has made all the difference). Item 2 is as follows: In a similar way, please circle the number below that matches your degree of change since beginning care at this clinic (0-10 scale): 0= Much better, 5= No change, 10= Much worse.	Will be assessed at end of two week treatment period
Overall Improvement (Using the Crossover Comparison Structure of the Study)	The Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment. Item 1 is as follows: Since beginning treatment at this clinic, how would you describe the change (if any) in ACTIVITY LIMITATIONS, SYMPTOMS, EMOTIONS, and OVERALL QUALITY OF LIFE, related to your painful condition? (tick ONE box) (1=No change (or condition has gotten worse), 2=Almost the same, hardly any change at all, 3=A little better, but no noticeable change, 4=Somewhat better, but the change has not made any real difference, 5=Moderately better, and a slight but noticeable change, 6=Better, and a definite improvement that has made a real and worthwhile difference, 7=A great deal better, and a considerable improvement that has made all the difference). Item 2 is as follows: In a similar way, please circle the number below that matches your degree of change since beginning care at this clinic (0-10 scale): 0= Much better, 5= No change, 10= Much worse.	Will be assessed at end of two week treatment period
Categorical Rating of Pain Intensity (First Treatment Period Only)	Assessed using number of days rated as none, mild, moderate, or severe in pain diary	Assessed at end of two week treatment period
Categorical Rating of Pain Intensity (Using the Crossover Comparison Structure of the Study)	Assessed using number of days rated as none, mild, moderate, or severe in pain diary	Assessed at end of two week treatment period
Breakthrough Treatment (First Treatment Period Only)	Number of days breakthrough pain medication was taken	Assessed during two week treatment period
Breakthrough Treatment (Using the Crossover Comparison Structure of the Study)	Number of days breakthrough pain medication was taken	Assessed during two week treatment period
Missed Medication Dose (First Treatment Period Only)	Number of missed medication doses	Assessed during two week treatment period
Missed Medication Doses (Using the Crossover Comparison Structure of the Study)	Number of missed medication doses	Assessed during two week treatment period

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Brian J Wainger, MD, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): August 10, 2017
• Study Completion (Actual): August 10, 2017

Study Registration Dates

• First Submitted: August 14, 2012
• First Submitted That Met QC Criteria: August 16, 2012
• First Posted (Estimate): August 17, 2012

Study Record Updates

• Last Update Posted (Actual): August 22, 2018
• Last Update Submitted That Met QC Criteria: July 26, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Pain; Physiological Effects of Drugs; Anti-Infective Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Gastrointestinal Agents; Sulfasalazine
• Other Study ID Numbers: 2012-p-001443