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Study of Sulfasalazine in Treating Painful Neuropathy

Primary Purpose

Painful Neuropathy

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sulfasalazine
placebo
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Painful Neuropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

sulfasalazine

placebo

Arm Description

1 g oral twice daily for 2 weeks

oral placebo pill twice daily for two weeks.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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.
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.
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).
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).
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).
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).
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.
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.
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.
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.
Categorical Rating of Pain Intensity (First Treatment Period Only)
Assessed using number of days rated as none, mild, moderate, or severe in pain diary
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
Breakthrough Treatment (First Treatment Period Only)
Number of days breakthrough pain medication was taken
Breakthrough Treatment (Using the Crossover Comparison Structure of the Study)
Number of days breakthrough pain medication was taken
Missed Medication Dose (First Treatment Period Only)
Number of missed medication doses
Missed Medication Doses (Using the Crossover Comparison Structure of the Study)
Number of missed medication doses

Full Information

First Posted
August 14, 2012
Last Updated
July 26, 2018
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01667029
Brief Title
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

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
poor enrollment
Study Start Date
May 2013 (undefined)
Primary Completion Date
August 10, 2017 (Actual)
Study Completion Date
August 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Painful Neuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sulfasalazine
Arm Type
Experimental
Arm Description
1 g oral twice daily for 2 weeks
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
oral placebo pill twice daily for two weeks.
Intervention Type
Drug
Intervention Name(s)
Sulfasalazine
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Pain Score (First Treatment Period)
Description
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).
Time Frame
second week of two week treatment period
Secondary Outcome Measure Information:
Title
Pain Score (Using the Crossover Comparison Structure of the Study)
Description
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).
Time Frame
Assessed at end of two week treatment period
Title
Number of Patients With >=50% Pain Reduction (First Treatment Period)
Description
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.
Time Frame
second week of two week treatment period
Title
Number of Patients With >=50% Pain Reduction (Using the Crossover Comparison Structure of the Study)
Description
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.
Time Frame
Assessed at end of two week treatment period
Title
Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (First Treatment Period Only)
Description
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).
Time Frame
Assessed at end of two week treatment period
Title
Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only)
Description
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).
Time Frame
Assessed at end of two week treatment period
Title
Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (Using the Crossover Comparison Structure of the Study)
Description
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).
Time Frame
Assessed at end of two week treatment period
Title
Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study)
Description
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).
Time Frame
Assessed at end of two week treatment period
Title
Emotional Functioning (First Treatment Period Only)
Description
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.
Time Frame
Assessed at end of two week treatment period
Title
Emotional Functioning (Using the Crossover Comparison Structure of the Study)
Description
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.
Time Frame
Assessed at end of two week treatment period
Title
Overall Improvement (First Treatment Period Only)
Description
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.
Time Frame
Will be assessed at end of two week treatment period
Title
Overall Improvement (Using the Crossover Comparison Structure of the Study)
Description
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.
Time Frame
Will be assessed at end of two week treatment period
Title
Categorical Rating of Pain Intensity (First Treatment Period Only)
Description
Assessed using number of days rated as none, mild, moderate, or severe in pain diary
Time Frame
Assessed at end of two week treatment period
Title
Categorical Rating of Pain Intensity (Using the Crossover Comparison Structure of the Study)
Description
Assessed using number of days rated as none, mild, moderate, or severe in pain diary
Time Frame
Assessed at end of two week treatment period
Title
Breakthrough Treatment (First Treatment Period Only)
Description
Number of days breakthrough pain medication was taken
Time Frame
Assessed during two week treatment period
Title
Breakthrough Treatment (Using the Crossover Comparison Structure of the Study)
Description
Number of days breakthrough pain medication was taken
Time Frame
Assessed during two week treatment period
Title
Missed Medication Dose (First Treatment Period Only)
Description
Number of missed medication doses
Time Frame
Assessed during two week treatment period
Title
Missed Medication Doses (Using the Crossover Comparison Structure of the Study)
Description
Number of missed medication doses
Time Frame
Assessed during two week treatment period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian J Wainger, MD, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

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Study of Sulfasalazine in Treating Painful Neuropathy

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