Study of Sulfasalazine in Treating Painful Neuropathy

NCT01667029 | Terminated Phase 2 Results

• 1 other identifier: 2012-p-001443
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Painful Neuropathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Pain Score (Using the Crossover Comparison Structure of the Study)

  Assessed at end of two week treatment period

• Number of Patients With >=50% Pain Reduction (First Treatment Period)

  second week of two week treatment period

• Number of Patients With >=50% Pain Reduction (Using the Crossover Comparison Structure of the Study)

  Assessed at end of two week treatment period

• Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (First Treatment Period Only)

  Assessed at end of two week treatment period

• Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only)

  Assessed at end of two week treatment period

Study Arms (2)

sulfasalazine

EXPERIMENTAL

1 g oral twice daily for 2 weeks

Drug: Sulfasalazine

placebo

PLACEBO COMPARATOR

oral placebo pill twice daily for two weeks.

Drug: placebo

Interventions

Sulfasalazine DRUG

sulfasalazine

placebo DRUG

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Neuropathy, Painful

Interventions

Sulfasalazine

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds

Results Point of Contact

• Title: Dr. Brian Wainger
• Organization: Massachusetts General Hospital

Brian.Wainger@mgh.harvard.edu

617-726-8810

Study Officials

• Brian J Wainger, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 14, 2012
• First Posted: August 17, 2012
• Study Start: May 1, 2013
• Primary Completion: August 10, 2017
• Study Completion: August 10, 2017
• Last Updated: August 22, 2018
• Results First Posted: August 22, 2018

Record last verified: 2018-07

Locations

US (1)