Study of Sulfasalazine in Treating Painful Neuropathy

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01667029
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Arms: 2
• Duration (Months): 51.3
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Painful Neuropathy	Drug: Sulfasalazine; Drug: placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Single-center, Randomized, Double-blind Clinical Study to Evaluate the Effect of Sulfasalazine on Painful Neuropathy
• Study Start Date: May 1, 2013
• Actual Primary Completion Date: Aug 10, 2017
• Actual Study Completion Date: Aug 10, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Pain Score (First Treatment Period) [second week of two week 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

1. Pain Score (Using the Crossover Comparison Structure of the Study) [Assessed at end of two week 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).

2. Number of Patients With >=50% Pain Reduction (First Treatment Period) [second week of two week 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.

3. Number of Patients With >=50% Pain Reduction (Using the Crossover Comparison Structure of the Study) [Assessed at end of two week treatment period]

   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.

4. Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (First Treatment Period Only) [Assessed at end of two week treatment period]

   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).

5. Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only) [Assessed at end of two week treatment period]

   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).

6. Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (Using the Crossover Comparison Structure of the Study) [Assessed at end of two week treatment period]

   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).

7. Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study) [Assessed at end of two week treatment period]

   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).

8. Emotional Functioning (First Treatment Period Only) [Assessed at end of two week treatment period]

   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.

9. Emotional Functioning (Using the Crossover Comparison Structure of the Study) [Assessed at end of two week treatment period]

   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.

10. Overall Improvement (First Treatment Period Only) [Will be assessed at end of two week treatment period]

    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.

11. Overall Improvement (Using the Crossover Comparison Structure of the Study) [Will be assessed at end of two week treatment period]

    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.

12. Categorical Rating of Pain Intensity (First Treatment Period Only) [Assessed at end of two week treatment period]

    Assessed using number of days rated as none, mild, moderate, or severe in pain diary

13. Categorical Rating of Pain Intensity (Using the Crossover Comparison Structure of the Study) [Assessed at end of two week treatment period]

    Assessed using number of days rated as none, mild, moderate, or severe in pain diary

14. Breakthrough Treatment (First Treatment Period Only) [Assessed during two week treatment period]

    Number of days breakthrough pain medication was taken

15. Breakthrough Treatment (Using the Crossover Comparison Structure of the Study) [Assessed during two week treatment period]

    Number of days breakthrough pain medication was taken

16. Missed Medication Dose (First Treatment Period Only) [Assessed during two week treatment period]

    Number of missed medication doses

17. Missed Medication Doses (Using the Crossover Comparison Structure of the Study) [Assessed during two week treatment period]

    Number of missed medication doses

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital

Investigators

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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 20, 2015

More Information

Publications

None provided.

• Responsible Party: Brian Wainger, Principal Investigator, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT01667029
• Other Study ID Numbers: 2012-p-001443
• First Posted: Aug 17, 2012
• Last Update Posted: Aug 22, 2018
• Last Verified: Jul 1, 2018

• Additional relevant MeSH terms: Pain; Sulfasalazine

Study Results

Participant Flow

Arm/Group Title	Sulfasalazine Then Placebo	Placebo Then Sulfasalazine
Arm/Group Description	Sulfasalazine (1 g oral twice daily) for two weeks, washout period of one week, placebo for 2 week period	Oral placebo pill twice daily for two weeks, washout period of one week, sulfasalazine for 2 week period
Period Title: Overall Study
STARTED	4	4
COMPLETED	3	3
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	All Study Participants
Arm/Group Description	Participants who were randomized to either Group A or Group B: Group A: Placebo daily for two weeks, washout period of one week, sulfasalazine for 2 week period Group B: Sulfasalazine daily for two weeks, washout period of one week, placebo for 2 week period.
Overall Participants	8
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	7 87.5%
>=65 years	1 12.5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58 (5.40)
Sex: Female, Male (Count of Participants)
Female	4 50%
Male	4 50%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	8 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	2 25%
White	6 75%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	8 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulfasalazine	Placebo
Arm/Group Description	1 g oral twice daily for 2 weeks Sulfasalazine	oral placebo pill twice daily for two weeks. placebo
Measure Participants	4	4
Mean (Standard Deviation) [units on a scale]	5.60 (1.35)	4.20 (0.91)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

8 participants were randomized, but 2 participants did not complete the second period of the study. So 6 participants received both sulfasalazine and placebo treatments, one only received sulfasalazine in period 1, and one only received placebo in period 1.

Arm/Group Title	Sulfasalazine	Placebo
Arm/Group Description	1 g oral twice daily for 2 weeks Sulfasalazine	oral placebo pill twice daily for two weeks. placebo
Measure Participants	7	7
Mean (Standard Deviation) [units on a scale]	4.91 (1.38)	3.93 (2.08)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulfasalazine	Placebo
Arm/Group Description	1 g oral twice daily for 2 weeks Sulfasalazine	oral placebo pill twice daily for two weeks. placebo
Measure Participants	4	4
Count of Participants [Participants]	0 0%	0 NaN

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

8 participants were randomized, but 2 participants did not complete the second period of the study. So 6 participants received both sulfasalazine and placebo treatments, one only received sulfasalazine in period 1, and one only received placebo in period 1.

Arm/Group Title	Sulfasalazine	Placebo
Arm/Group Description	1 g oral twice daily for 2 weeks Sulfasalazine	oral placebo pill twice daily for two weeks. placebo
Measure Participants	7	7
Count of Participants [Participants]	0 0%	1 NaN

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulfasalazine	Placebo
Arm/Group Description	1 g oral twice daily for 2 weeks Sulfasalazine	oral placebo pill twice daily for two weeks. placebo
Measure Participants	4	4
General activity	5.25 (2.75)	4.00 (1.41)
Mood	3.75 (3.86)	5.00 (2.16)
Walking ability	4.50 (3.87)	5.50 (2.08)
Normal work	5.25 (4.03)	4.75 (2.50)
Relations with other people	1.25 (2.50)	3.75 (1.71)
Sleep	5.00 (3.56)	5.25 (2.22)
Enjoyment of life	5.75 (4.65)	4.75 (2.50)

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulfasalazine	Placebo
Arm/Group Description	1 g oral twice daily for 2 weeks Sulfasalazine	oral placebo pill twice daily for two weeks. placebo
Measure Participants	4	4
1	1 12.5%	1 NaN
2	1 12.5%	2 NaN
3	2 25%	0 NaN
4	0 0%	1 NaN
5	0 0%	0 NaN
1	3 37.5%	4 NaN
2	1 12.5%	0 NaN
3	0 0%	0 NaN
4	0 0%	0 NaN
5	0 0%	0 NaN
1	2 25%	1 NaN
2	1 12.5%	1 NaN
3	1 12.5%	2 NaN
4	0 0%	0 NaN
5	0 0%	0 NaN

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

8 participants were randomized, but 2 participants did not complete the second period of the study. So 6 participants received both sulfasalazine and placebo treatments, one only received sulfasalazine in period 1, and one only received placebo in period 1

Arm/Group Title	Sulfasalazine	Placebo
Arm/Group Description	1 g oral twice daily for 2 weeks Sulfasalazine	oral placebo pill twice daily for two weeks. placebo
Measure Participants	7	7
General activity	4.00 (2.77)	3.71 (2.06)
Mood	3.57 (3.10)	4.00 (2.94)
Walking ability	3.57 (3.21)	4.57 (2.57)
Normal work	4.14 (3.48)	4.14 (2.61)
Relations with other people	1.43 (2.15)	2.57 (1.99)
Sleep	4.86 (3.24)	4.43 (2.76)
Enjoyment of life	4.57 (4.39)	4.00 (3.61)

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

8 participants were randomized, but 2 participants did not complete the second period of the study. So 6 participants received both sulfasalazine and placebo treatments, one only received sulfasalazine in period 1, and one only received placebo in period 1.

Arm/Group Title	Sulfasalazine	Placebo
Arm/Group Description	1 g oral twice daily for 2 weeks Sulfasalazine	oral placebo pill twice daily for two weeks. placebo
Measure Participants	7	7
1	4 50%	2 NaN
2	1 12.5%	3 NaN
3	2 25%	1 NaN
4	0 0%	1 NaN
5	0 0%	0 NaN
1	5 62.5%	7 NaN
2	2 25%	0 NaN
3	0 0%	0 NaN
4	0 0%	0 NaN
5	0 0%	0 NaN
1	4 50%	2 NaN
2	2 25%	2 NaN
3	1 12.5%	3 NaN
4	0 0%	0 NaN
5	0 0%	0 NaN

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulfasalazine	Placebo
Arm/Group Description	1 g oral twice daily for 2 weeks Sulfasalazine	oral placebo pill twice daily for two weeks. placebo
Measure Participants	4	4
Mean (Standard Deviation) [units on a scale]	8.25 (5.12)	10.50 (6.61)

10. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

8 participants were randomized, but 2 participants did not complete the second period of the study. So 6 participants received both sulfasalazine and placebo treatments, one only received sulfasalazine in period 1, and one only received placebo in period 1.

Arm/Group Title	Sulfasalazine	Placebo
Arm/Group Description	1 g oral twice daily for 2 weeks Sulfasalazine	oral placebo pill twice daily for two weeks. placebo
Measure Participants	7	7
Mean (Standard Deviation) [units on a scale]	7.29 (5.91)	8.29 (6.29)

11. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

2 participants in the sulfasalazine group are missing PGIC information.

Arm/Group Title	Sulfasalazine	Placebo
Arm/Group Description	1 g oral twice daily for 2 weeks Sulfasalazine	oral placebo pill twice daily for two weeks. placebo
Measure Participants	2	4
PGIC Item 1	1.50 (0.71)	1.75 (0.96)
PGIC Item 2	5.00 (0.00)	4.50 (1.00)

12. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

8 participants were randomized, but 2 participants did not complete the second period of the study. So 6 participants received both sulfasalazine and placebo treatments, one only received sulfasalazine in period 1, and one only received placebo in period 1. 2 of the sulfasalzine participants are missing PGIC.

Arm/Group Title	Sulfasalazine	Placebo
Arm/Group Description	1 g oral twice daily for 2 weeks Sulfasalazine	oral placebo pill twice daily for two weeks. placebo
Measure Participants	5	7
PGIC item 1	2.80 (2.39)	3.00 (2.08)
PGIC item 2	4.00 (1.73)	3.56 (1.81)

13. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

One participant in the sulfasalazine arm did not complete the categorical pain data.

Arm/Group Title	Sulfasalazine	Placebo
Arm/Group Description	1 g oral twice daily for 2 weeks Sulfasalazine	oral placebo pill twice daily for two weeks. placebo
Measure Participants	3	4
"None" rating	0 (0)	0 (0)
"Mild" rating	1.67 (2.89)	1.75 (3.50)
"Moderate" rating	4.33 (2.52)	5.25 (3.50)
"Severe" rating	1.00 (1.73)	0 (0)

14. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

8 participants were randomized, but 2 participants did not complete the second period of the study. So 6 participants received both sulfasalazine and placebo treatments, one only received sulfasalazine in period 1, and one only received placebo in period 1. One participant did not complete the categorical pain data in either period.

Arm/Group Title	Sulfasalazine	Placebo
Arm/Group Description	1 g oral twice daily for 2 weeks Sulfasalazine	oral placebo pill twice daily for two weeks. placebo
Measure Participants	6	6
"None" rating	0 (0)	1.17 (2.86)
"Mild" rating	2.00 (3.16)	1.83 (2.99)
"Moderate" rating	4.33 (2.88)	3.83 (3.54)
"Severe" rating	0.67 (1.21)	0.17 (0.41)

15. Secondary Outcome

Title	Breakthrough Treatment (First Treatment Period Only)
Description	Number of days breakthrough pain medication was taken
Time Frame	Assessed during two week treatment period

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulfasalazine	Placebo
Arm/Group Description	1 g oral twice daily for 2 weeks Sulfasalazine	oral placebo pill twice daily for two weeks. placebo
Measure Participants	4	4
Mean (Standard Deviation) [days]	0.75 (0.96)	2.00 (2.83)

16. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

8 participants were randomized, but 2 participants did not complete the second period of the study. So 6 participants received both sulfasalazine and placebo treatments, one only received sulfasalazine in period 1, and one only received placebo in period 1.

Arm/Group Title	Sulfasalazine	Placebo
Arm/Group Description	1 g oral twice daily for 2 weeks Sulfasalazine	oral placebo pill twice daily for two weeks. placebo
Measure Participants	7	7
Mean (Standard Deviation) [days]	1.29 (2.21)	1.14 (2.27)

17. Secondary Outcome

Title	Missed Medication Dose (First Treatment Period Only)
Description	Number of missed medication doses
Time Frame	Assessed during two week treatment period

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sulfasalazine	Placebo
Arm/Group Description	1 g oral twice daily for 2 weeks Sulfasalazine	oral placebo pill twice daily for two weeks. placebo
Measure Participants	4	4
Mean (Standard Deviation) [dose]	0 (0)	0 (0)

18. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

8 participants were randomized, but 2 participants did not complete the second period of the study. So 6 participants received both sulfasalazine and placebo treatments, one only received sulfasalazine in period 1, and one only received placebo in period 1.

Arm/Group Title	Sulfasalazine	Placebo
Arm/Group Description	1 g oral twice daily for 2 weeks Sulfasalazine	oral placebo pill twice daily for two weeks. placebo
Measure Participants	7	7
Mean (Standard Deviation) [doses]	0.43 (1.13)	0 (0)

Adverse Events

Time Frame	Two study periods that were each two weeks in length.
Arm/Group Title	Sulfasalazine		Placebo
Arm/Group Description	1 g oral twice daily for 2 weeks Sulfasalazine		oral placebo pill twice daily for two weeks. placebo
All Cause Mortality
	Sulfasalazine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/8 (0%)
Serious Adverse Events
	Sulfasalazine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/8 (0%)
Other (Not Including Serious) Adverse Events
	Sulfasalazine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		1/8 (12.5%)
Skin and subcutaneous tissue disorders
rash	0/8 (0%)	0	1/8 (12.5%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.