Trial Outcomes & Findings for Study of Sulfasalazine in Treating Painful Neuropathy (NCT NCT01667029)
NCT ID: NCT01667029
Last Updated: 2018-08-22
Results Overview
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).
TERMINATED
PHASE2
8 participants
second week of two week treatment period
2018-08-22
Participant Flow
Participant milestones
| Measure |
Sulfasalazine Then Placebo
Sulfasalazine (1 g oral twice daily) for two weeks, washout period of one week, placebo for 2 week period
|
Placebo Then Sulfasalazine
Oral placebo pill twice daily for two weeks, washout period of one week, sulfasalazine for 2 week period
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
|
Overall Study
COMPLETED
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Sulfasalazine in Treating Painful Neuropathy
Baseline characteristics by cohort
| Measure |
All Study Participants
n=8 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 5.40 • n=99 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: second week of two week treatment periodAverage 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).
Outcome measures
| Measure |
Sulfasalazine
n=4 Participants
1 g oral twice daily for 2 weeks
Sulfasalazine
|
Placebo
n=4 Participants
oral placebo pill twice daily for two weeks.
placebo
|
|---|---|---|
|
Pain Score (First Treatment Period)
|
5.60 units on a scale
Standard Deviation 1.35
|
4.20 units on a scale
Standard Deviation 0.91
|
SECONDARY outcome
Timeframe: Assessed at end of two week treatment periodPopulation: 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.
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).
Outcome measures
| Measure |
Sulfasalazine
n=7 Participants
1 g oral twice daily for 2 weeks
Sulfasalazine
|
Placebo
n=7 Participants
oral placebo pill twice daily for two weeks.
placebo
|
|---|---|---|
|
Pain Score (Using the Crossover Comparison Structure of the Study)
|
4.91 units on a scale
Standard Deviation 1.38
|
3.93 units on a scale
Standard Deviation 2.08
|
SECONDARY outcome
Timeframe: second week of two week treatment periodAverage 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.
Outcome measures
| Measure |
Sulfasalazine
n=4 Participants
1 g oral twice daily for 2 weeks
Sulfasalazine
|
Placebo
n=4 Participants
oral placebo pill twice daily for two weeks.
placebo
|
|---|---|---|
|
Number of Patients With >=50% Pain Reduction (First Treatment Period)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Assessed at end of two week treatment periodPopulation: 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.
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.
Outcome measures
| Measure |
Sulfasalazine
n=7 Participants
1 g oral twice daily for 2 weeks
Sulfasalazine
|
Placebo
n=7 Participants
oral placebo pill twice daily for two weeks.
placebo
|
|---|---|---|
|
Number of Patients With >=50% Pain Reduction (Using the Crossover Comparison Structure of the Study)
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Assessed at end of two week treatment periodThe 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).
Outcome measures
| Measure |
Sulfasalazine
n=4 Participants
1 g oral twice daily for 2 weeks
Sulfasalazine
|
Placebo
n=4 Participants
oral placebo pill twice daily for two weeks.
placebo
|
|---|---|---|
|
Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (First Treatment Period Only)
General activity
|
5.25 units on a scale
Standard Deviation 2.75
|
4.00 units on a scale
Standard Deviation 1.41
|
|
Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (First Treatment Period Only)
Mood
|
3.75 units on a scale
Standard Deviation 3.86
|
5.00 units on a scale
Standard Deviation 2.16
|
|
Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (First Treatment Period Only)
Walking ability
|
4.50 units on a scale
Standard Deviation 3.87
|
5.50 units on a scale
Standard Deviation 2.08
|
|
Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (First Treatment Period Only)
Normal work
|
5.25 units on a scale
Standard Deviation 4.03
|
4.75 units on a scale
Standard Deviation 2.50
|
|
Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (First Treatment Period Only)
Relations with other people
|
1.25 units on a scale
Standard Deviation 2.50
|
3.75 units on a scale
Standard Deviation 1.71
|
|
Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (First Treatment Period Only)
Sleep
|
5.00 units on a scale
Standard Deviation 3.56
|
5.25 units on a scale
Standard Deviation 2.22
|
|
Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (First Treatment Period Only)
Enjoyment of life
|
5.75 units on a scale
Standard Deviation 4.65
|
4.75 units on a scale
Standard Deviation 2.50
|
SECONDARY outcome
Timeframe: Assessed at end of two week treatment periodThe EQ-5D physical functioning items are mobility self-care, and usual activities. These three items are rated from 1 (no problems) to 5 (unable).
Outcome measures
| Measure |
Sulfasalazine
n=4 Participants
1 g oral twice daily for 2 weeks
Sulfasalazine
|
Placebo
n=4 Participants
oral placebo pill twice daily for two weeks.
placebo
|
|---|---|---|
|
Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only)
EQ-5D usual activities · 3
|
1 Participants
|
2 Participants
|
|
Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only)
EQ-5D mobility · 1
|
1 Participants
|
1 Participants
|
|
Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only)
EQ-5D mobility · 2
|
1 Participants
|
2 Participants
|
|
Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only)
EQ-5D mobility · 3
|
2 Participants
|
0 Participants
|
|
Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only)
EQ-5D mobility · 4
|
0 Participants
|
1 Participants
|
|
Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only)
EQ-5D mobility · 5
|
0 Participants
|
0 Participants
|
|
Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only)
EQ-5D self-care · 1
|
3 Participants
|
4 Participants
|
|
Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only)
EQ-5D self-care · 2
|
1 Participants
|
0 Participants
|
|
Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only)
EQ-5D self-care · 3
|
0 Participants
|
0 Participants
|
|
Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only)
EQ-5D self-care · 4
|
0 Participants
|
0 Participants
|
|
Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only)
EQ-5D self-care · 5
|
0 Participants
|
0 Participants
|
|
Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only)
EQ-5D usual activities · 1
|
2 Participants
|
1 Participants
|
|
Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only)
EQ-5D usual activities · 2
|
1 Participants
|
1 Participants
|
|
Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only)
EQ-5D usual activities · 4
|
0 Participants
|
0 Participants
|
|
Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only)
EQ-5D usual activities · 5
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Assessed at end of two week treatment periodPopulation: 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
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).
Outcome measures
| Measure |
Sulfasalazine
n=7 Participants
1 g oral twice daily for 2 weeks
Sulfasalazine
|
Placebo
n=7 Participants
oral placebo pill twice daily for two weeks.
placebo
|
|---|---|---|
|
Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (Using the Crossover Comparison Structure of the Study)
General activity
|
4.00 units on a scale
Standard Deviation 2.77
|
3.71 units on a scale
Standard Deviation 2.06
|
|
Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (Using the Crossover Comparison Structure of the Study)
Mood
|
3.57 units on a scale
Standard Deviation 3.10
|
4.00 units on a scale
Standard Deviation 2.94
|
|
Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (Using the Crossover Comparison Structure of the Study)
Walking ability
|
3.57 units on a scale
Standard Deviation 3.21
|
4.57 units on a scale
Standard Deviation 2.57
|
|
Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (Using the Crossover Comparison Structure of the Study)
Normal work
|
4.14 units on a scale
Standard Deviation 3.48
|
4.14 units on a scale
Standard Deviation 2.61
|
|
Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (Using the Crossover Comparison Structure of the Study)
Relations with other people
|
1.43 units on a scale
Standard Deviation 2.15
|
2.57 units on a scale
Standard Deviation 1.99
|
|
Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (Using the Crossover Comparison Structure of the Study)
Sleep
|
4.86 units on a scale
Standard Deviation 3.24
|
4.43 units on a scale
Standard Deviation 2.76
|
|
Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (Using the Crossover Comparison Structure of the Study)
Enjoyment of life
|
4.57 units on a scale
Standard Deviation 4.39
|
4.00 units on a scale
Standard Deviation 3.61
|
SECONDARY outcome
Timeframe: Assessed at end of two week treatment periodPopulation: 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.
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).
Outcome measures
| Measure |
Sulfasalazine
n=7 Participants
1 g oral twice daily for 2 weeks
Sulfasalazine
|
Placebo
n=7 Participants
oral placebo pill twice daily for two weeks.
placebo
|
|---|---|---|
|
Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study)
EQ-5D mobility · 5
|
0 Participants
|
0 Participants
|
|
Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study)
EQ-5D mobility · 1
|
4 Participants
|
2 Participants
|
|
Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study)
EQ-5D mobility · 2
|
1 Participants
|
3 Participants
|
|
Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study)
EQ-5D mobility · 3
|
2 Participants
|
1 Participants
|
|
Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study)
EQ-5D mobility · 4
|
0 Participants
|
1 Participants
|
|
Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study)
EQ-5D self-care · 1
|
5 Participants
|
7 Participants
|
|
Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study)
EQ-5D self-care · 2
|
2 Participants
|
0 Participants
|
|
Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study)
EQ-5D self-care · 3
|
0 Participants
|
0 Participants
|
|
Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study)
EQ-5D self-care · 4
|
0 Participants
|
0 Participants
|
|
Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study)
EQ-5D self-care · 5
|
0 Participants
|
0 Participants
|
|
Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study)
EQ-5D usual activities · 1
|
4 Participants
|
2 Participants
|
|
Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study)
EQ-5D usual activities · 2
|
2 Participants
|
2 Participants
|
|
Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study)
EQ-5D usual activities · 3
|
1 Participants
|
3 Participants
|
|
Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study)
EQ-5D usual activities · 4
|
0 Participants
|
0 Participants
|
|
Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study)
EQ-5D usual activities · 5
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Assessed at end of two week treatment periodWill 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.
Outcome measures
| Measure |
Sulfasalazine
n=4 Participants
1 g oral twice daily for 2 weeks
Sulfasalazine
|
Placebo
n=4 Participants
oral placebo pill twice daily for two weeks.
placebo
|
|---|---|---|
|
Emotional Functioning (First Treatment Period Only)
|
8.25 units on a scale
Standard Deviation 5.12
|
10.50 units on a scale
Standard Deviation 6.61
|
SECONDARY outcome
Timeframe: Assessed at end of two week treatment periodPopulation: 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.
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.
Outcome measures
| Measure |
Sulfasalazine
n=7 Participants
1 g oral twice daily for 2 weeks
Sulfasalazine
|
Placebo
n=7 Participants
oral placebo pill twice daily for two weeks.
placebo
|
|---|---|---|
|
Emotional Functioning (Using the Crossover Comparison Structure of the Study)
|
7.29 units on a scale
Standard Deviation 5.91
|
8.29 units on a scale
Standard Deviation 6.29
|
SECONDARY outcome
Timeframe: Will be assessed at end of two week treatment periodPopulation: 2 participants in the sulfasalazine group are missing PGIC information.
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.
Outcome measures
| Measure |
Sulfasalazine
n=2 Participants
1 g oral twice daily for 2 weeks
Sulfasalazine
|
Placebo
n=4 Participants
oral placebo pill twice daily for two weeks.
placebo
|
|---|---|---|
|
Overall Improvement (First Treatment Period Only)
PGIC Item 1
|
1.50 units on a scale
Standard Deviation 0.71
|
1.75 units on a scale
Standard Deviation 0.96
|
|
Overall Improvement (First Treatment Period Only)
PGIC Item 2
|
5.00 units on a scale
Standard Deviation 0.00
|
4.50 units on a scale
Standard Deviation 1.00
|
SECONDARY outcome
Timeframe: Will be assessed at end of two week treatment periodPopulation: 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.
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.
Outcome measures
| Measure |
Sulfasalazine
n=5 Participants
1 g oral twice daily for 2 weeks
Sulfasalazine
|
Placebo
n=7 Participants
oral placebo pill twice daily for two weeks.
placebo
|
|---|---|---|
|
Overall Improvement (Using the Crossover Comparison Structure of the Study)
PGIC item 1
|
2.80 units on a scale
Standard Deviation 2.39
|
3.00 units on a scale
Standard Deviation 2.08
|
|
Overall Improvement (Using the Crossover Comparison Structure of the Study)
PGIC item 2
|
4.00 units on a scale
Standard Deviation 1.73
|
3.56 units on a scale
Standard Deviation 1.81
|
SECONDARY outcome
Timeframe: Assessed at end of two week treatment periodPopulation: One participant in the sulfasalazine arm did not complete the categorical pain data.
Assessed using number of days rated as none, mild, moderate, or severe in pain diary
Outcome measures
| Measure |
Sulfasalazine
n=3 Participants
1 g oral twice daily for 2 weeks
Sulfasalazine
|
Placebo
n=4 Participants
oral placebo pill twice daily for two weeks.
placebo
|
|---|---|---|
|
Categorical Rating of Pain Intensity (First Treatment Period Only)
"Moderate" rating
|
4.33 days
Standard Deviation 2.52
|
5.25 days
Standard Deviation 3.50
|
|
Categorical Rating of Pain Intensity (First Treatment Period Only)
"None" rating
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
|
Categorical Rating of Pain Intensity (First Treatment Period Only)
"Mild" rating
|
1.67 days
Standard Deviation 2.89
|
1.75 days
Standard Deviation 3.50
|
|
Categorical Rating of Pain Intensity (First Treatment Period Only)
"Severe" rating
|
1.00 days
Standard Deviation 1.73
|
0 days
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Assessed at end of two week treatment periodPopulation: 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.
Assessed using number of days rated as none, mild, moderate, or severe in pain diary
Outcome measures
| Measure |
Sulfasalazine
n=6 Participants
1 g oral twice daily for 2 weeks
Sulfasalazine
|
Placebo
n=6 Participants
oral placebo pill twice daily for two weeks.
placebo
|
|---|---|---|
|
Categorical Rating of Pain Intensity (Using the Crossover Comparison Structure of the Study)
"Severe" rating
|
0.67 days
Standard Deviation 1.21
|
0.17 days
Standard Deviation 0.41
|
|
Categorical Rating of Pain Intensity (Using the Crossover Comparison Structure of the Study)
"None" rating
|
0 days
Standard Deviation 0
|
1.17 days
Standard Deviation 2.86
|
|
Categorical Rating of Pain Intensity (Using the Crossover Comparison Structure of the Study)
"Mild" rating
|
2.00 days
Standard Deviation 3.16
|
1.83 days
Standard Deviation 2.99
|
|
Categorical Rating of Pain Intensity (Using the Crossover Comparison Structure of the Study)
"Moderate" rating
|
4.33 days
Standard Deviation 2.88
|
3.83 days
Standard Deviation 3.54
|
SECONDARY outcome
Timeframe: Assessed during two week treatment periodNumber of days breakthrough pain medication was taken
Outcome measures
| Measure |
Sulfasalazine
n=4 Participants
1 g oral twice daily for 2 weeks
Sulfasalazine
|
Placebo
n=4 Participants
oral placebo pill twice daily for two weeks.
placebo
|
|---|---|---|
|
Breakthrough Treatment (First Treatment Period Only)
|
0.75 days
Standard Deviation 0.96
|
2.00 days
Standard Deviation 2.83
|
SECONDARY outcome
Timeframe: Assessed during two week treatment periodPopulation: 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.
Number of days breakthrough pain medication was taken
Outcome measures
| Measure |
Sulfasalazine
n=7 Participants
1 g oral twice daily for 2 weeks
Sulfasalazine
|
Placebo
n=7 Participants
oral placebo pill twice daily for two weeks.
placebo
|
|---|---|---|
|
Breakthrough Treatment (Using the Crossover Comparison Structure of the Study)
|
1.29 days
Standard Deviation 2.21
|
1.14 days
Standard Deviation 2.27
|
SECONDARY outcome
Timeframe: Assessed during two week treatment periodNumber of missed medication doses
Outcome measures
| Measure |
Sulfasalazine
n=4 Participants
1 g oral twice daily for 2 weeks
Sulfasalazine
|
Placebo
n=4 Participants
oral placebo pill twice daily for two weeks.
placebo
|
|---|---|---|
|
Missed Medication Dose (First Treatment Period Only)
|
0 dose
Standard Deviation 0
|
0 dose
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Assessed during two week treatment periodPopulation: 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.
Number of missed medication doses
Outcome measures
| Measure |
Sulfasalazine
n=7 Participants
1 g oral twice daily for 2 weeks
Sulfasalazine
|
Placebo
n=7 Participants
oral placebo pill twice daily for two weeks.
placebo
|
|---|---|---|
|
Missed Medication Doses (Using the Crossover Comparison Structure of the Study)
|
0.43 doses
Standard Deviation 1.13
|
0 doses
Standard Deviation 0
|
Adverse Events
Sulfasalazine
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sulfasalazine
n=8 participants at risk
1 g oral twice daily for 2 weeks
Sulfasalazine
|
Placebo
n=8 participants at risk
oral placebo pill twice daily for two weeks.
placebo
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
rash
|
0.00%
0/8 • Two study periods that were each two weeks in length.
|
12.5%
1/8 • Number of events 1 • Two study periods that were each two weeks in length.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place