Clinical trial NCT01667029: Study of Sulfasalazine in Treating Painful Neuropathy
Official title: A Single-center, Randomized, Double-blind Clinical Study to Evaluate the Effect of Sulfasalazine on Painful Neuropathy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Painful Neuropathy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2012-08-17
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pain Score (First Treatment Period)
timeFrame: second week of two week treatment period
Secondary outcomes:
measure: Pain Score (Using the Crossover Comparison Structure of the Study)
timeFrame: Assessed at end of two week treatment period
measure: Number of Patients With >=50% Pain Reduction (First Treatment Period)
timeFrame: second week of two week treatment period
measure: Number of Patients With >=50% Pain Reduction (Using the Crossover Comparison Structure of the Study)
timeFrame: Assessed at end of two week treatment period
measure: Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (First Treatment Period Only)
timeFrame: Assessed at end of two week treatment period
measure: Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only)
timeFrame: Assessed at end of two week treatment period
measure: Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (Using the Crossover Comparison Structure of the Study)
timeFrame: Assessed at end of two week treatment period
measure: Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study)
timeFrame: Assessed at end of two week treatment period
measure: Emotional Functioning (First Treatment Period Only)
timeFrame: Assessed at end of two week treatment period
measure: Emotional Functioning (Using the Crossover Comparison Structure of the Study)
timeFrame: Assessed at end of two week treatment period
measure: Overall Improvement (First Treatment Period Only)
timeFrame: Will be assessed at end of two week treatment period
measure: Overall Improvement (Using the Crossover Comparison Structure of the Study)
timeFrame: Will be assessed at end of two week treatment period
measure: Categorical Rating of Pain Intensity (First Treatment Period Only)
timeFrame: Assessed at end of two week treatment period
measure: Categorical Rating of Pain Intensity (Using the Crossover Comparison Structure of the Study)
timeFrame: Assessed at end of two week treatment period
measure: Breakthrough Treatment (First Treatment Period Only)
timeFrame: Assessed during two week treatment period
measure: Breakthrough Treatment (Using the Crossover Comparison Structure of the Study)
timeFrame: Assessed during two week treatment period
measure: Missed Medication Dose (First Treatment Period Only)
timeFrame: Assessed during two week treatment period
measure: Missed Medication Doses (Using the Crossover Comparison Structure of the Study)
timeFrame: Assessed during two week treatment period
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Brian J Wainger, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: