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poor enrollment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sulfasalazine | Experimental | 1 g oral twice daily for 2 weeks |
|
| placebo | Placebo Comparator | oral placebo pill twice daily for two weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sulfasalazine | Drug |
| ||
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Assessed at end of two week treatment period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian J Wainger, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sulfasalazine Then Placebo | Sulfasalazine (1 g oral twice daily) for two weeks, washout period of one week, placebo for 2 week period |
| FG001 | Placebo Then Sulfasalazine | Oral placebo pill twice daily for two weeks, washout period of one week, sulfasalazine for 2 week period |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Deviation | units on a scale | second week of two week treatment period |
|
Two study periods that were each two weeks in length.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sulfasalazine | 1 g oral twice daily for 2 weeks Sulfasalazine | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brian Wainger | Massachusetts General Hospital | 617-726-8810 | Brian.Wainger@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 20, 2015 | Jul 16, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C564945 | Neuropathy, Painful |
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| ID | Term |
|---|---|
| D012460 | Sulfasalazine |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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|
| 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. | second week of two week treatment period |
| 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. | Assessed at end of two week treatment period |
| 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). | Assessed at end of two week treatment period |
| 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). | Assessed at end of two week treatment period |
| 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). | Assessed at end of two week treatment period |
| 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). | Assessed at end of two week treatment period |
| 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. | Assessed at end of two week treatment period |
| 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. | Assessed at end of two week treatment period |
| 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. | Will be assessed at end of two week treatment period |
| 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. | Will be assessed at end of two week treatment period |
| Categorical Rating of Pain Intensity (First Treatment Period Only) | Assessed using number of days rated as none, mild, moderate, or severe in pain diary | Assessed at end of two week treatment period |
| 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 | Assessed at end of two week treatment period |
| Breakthrough Treatment (First Treatment Period Only) | Number of days breakthrough pain medication was taken | Assessed during two week treatment period |
| Breakthrough Treatment (Using the Crossover Comparison Structure of the Study) | Number of days breakthrough pain medication was taken | Assessed during two week treatment period |
| Missed Medication Dose (First Treatment Period Only) | Number of missed medication doses | Assessed during two week treatment period |
| Missed Medication Doses (Using the Crossover Comparison Structure of the Study) | Number of missed medication doses | Assessed during two week treatment period |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | 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). | 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. | Posted | Mean | Standard Deviation | units on a scale | Assessed at end of two week treatment period |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | second week of two week treatment period |
|
|
|
| Secondary | 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. | 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. | Posted | Count of Participants | Participants | Assessed at end of two week treatment period |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | units on a scale | Assessed at end of two week treatment period |
|
|
|
| Secondary | 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). | Posted | Count of Participants | Participants | Assessed at end of two week treatment period |
|
|
|
| Secondary | 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). | 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 | Posted | Mean | Standard Deviation | units on a scale | Assessed at end of two week treatment period |
|
|
|
| Secondary | 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). | 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. | Posted | Count of Participants | Participants | Assessed at end of two week treatment period |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Assessed at end of two week treatment period |
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Assessed at end of two week treatment period |
|
|
|
| Secondary | 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. | 2 participants in the sulfasalazine group are missing PGIC information. | Posted | Mean | Standard Deviation | units on a scale | Will be assessed at end of two week treatment period |
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|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Will be assessed at end of two week treatment period |
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| Secondary | Categorical Rating of Pain Intensity (First Treatment Period Only) | Assessed using number of days rated as none, mild, moderate, or severe in pain diary | One participant in the sulfasalazine arm did not complete the categorical pain data. | Posted | Mean | Standard Deviation | days | Assessed at end of two week treatment period |
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| Secondary | 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 | 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. | Posted | Mean | Standard Deviation | days | Assessed at end of two week treatment period |
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| Secondary | Breakthrough Treatment (First Treatment Period Only) | Number of days breakthrough pain medication was taken | Posted | Mean | Standard Deviation | days | Assessed during two week treatment period |
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| Secondary | Breakthrough Treatment (Using the Crossover Comparison Structure of the Study) | Number of days breakthrough pain medication was taken | 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. | Posted | Mean | Standard Deviation | days | Assessed during two week treatment period |
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|
| Secondary | Missed Medication Dose (First Treatment Period Only) | Number of missed medication doses | Posted | Mean | Standard Deviation | dose | Assessed during two week treatment period |
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| Secondary | Missed Medication Doses (Using the Crossover Comparison Structure of the Study) | Number of missed medication doses | 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. | Posted | Mean | Standard Deviation | doses | Assessed during two week treatment period |
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|
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Placebo | oral placebo pill twice daily for two weeks. placebo | 0 | 8 | 0 | 8 | 1 | 8 |
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| Sulfur Compounds |
| Walking ability |
|
| Normal work |
|
| Relations with other people |
|
| Sleep |
|
| Enjoyment of life |
|
| 3 |
|
| 4 |
|
| 5 |
|
| EQ-5D self-care |
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| EQ-5D usual activities |
|
| Walking ability |
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| Normal work |
|
| Relations with other people |
|
| Sleep |
|
| Enjoyment of life |
|
| 3 |
|
| 4 |
|
| 5 |
|
| EQ-5D self-care |
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| EQ-5D usual activities |
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| "Moderate" rating |
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| "Severe" rating |
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| "Moderate" rating |
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| "Severe" rating |
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