Painful NeuropathyPhase 2NCT01667029
Study of Sulfasalazine in Treating Painful Neuropathy
A Phase 2 study testing Sulfasalazine in people with Painful Neuropathy, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Painful Neuropathy
- What is being tested?
- Sulfasalazine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to 10 Aug 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Painful neuropathy
- Michigan Neuropathy Screening Instrument score of 3 or greater
- no obvious alternative explanation for neuropathy
- average baseline pain > 4/10
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: A Single-center, Randomized, Double-blind Clinical Study to Evaluate the Effect of Sulfasalazine on Painful Neuropathy
The investigators hypothesize that sulfasalazine, an FDA-approved medication for rheumatoid arthritis and ulcerative colitis, may be beneficial in neuropathic pain conditions. In this study, the investigators will evaluate whether sulfasalazine improves pain due to painful peripheral neuropathy.
- Conditions
- Painful Neuropathy
- Being tested
- Sulfasalazine, placebo
- Medical subject headings
- Neuropathy, Painful
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SulfasalazineDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| sulfasalazine | Experimental | 1 g oral twice daily for 2 weeks Receives: Drug: Sulfasalazine |
| placebo | Placebo comparator | oral placebo pill twice daily for two weeks. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: second week of two week treatment period
Secondary outcomes (17)
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).
Measured: Assessed at end of two week treatment period
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Assessed at end of two week treatment period
Breakthrough Treatment (First Treatment Period Only)
Number of days breakthrough pain medication was taken
Measured: Assessed during two week treatment period
Breakthrough Treatment (Using the Crossover Comparison Structure of the Study)
Number of days breakthrough pain medication was taken
Measured: Assessed during two week treatment period
Missed Medication Dose (First Treatment Period Only)
Number of missed medication doses
Measured: Assessed during two week treatment period
Missed Medication Doses (Using the Crossover Comparison Structure of the Study)
Number of missed medication doses
Measured: Assessed during two week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2012 (estimated)
- Study startMay 2013
- Primary completion10 Aug 2017
- Study completion10 Aug 2017
Why it stopped: poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Painful NeuropathyStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Wainger, Massachusetts General Hospital
- Investigators
- Brian J Wainger, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01667029
- Sponsor's protocol ID
- 2012-p-001443
- Status last verified
- Jul 2018
- First submitted
- 14 Aug 2012
- Last updated
- 22 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Double-blind Clinical Study to Evaluate the Effect of Sulfasalazine on Painful Neuropathy
- ClinicalTrials.gov ID
- NCT01667029
- Acronym / sponsor ID
- 2012-p-001443
- Conditions
- Painful Neuropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor enrollment
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- 10 Aug 2017 (actual)
- Study completion
- 10 Aug 2017 (actual)
- First posted
- 17 Aug 2012 (estimated)
- Results
- Posted 22 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sulfasalazine | Experimental | Drug: Sulfasalazine1 g oral twice daily for 2 weeks |
| placebo | Placebo comparator | Drug: placebooral placebo pill twice daily for two weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Painful neuropathy
- Michigan Neuropathy Screening Instrument score of 3 or greater
- no obvious alternative explanation for neuropathy
- average baseline pain > 4/10
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sulfasalazine | Drug | sulfasalazine |
| placebo | Drug | placebo |
Primary outcome
Pain Score (First Treatment Period)
Time frame: 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).
17 secondary outcomes
Pain Score (Using the Crossover Comparison Structure of the Study)
Time frame: Assessed at end of two week treatment period
Number of Patients With >=50% Pain Reduction (First Treatment Period)
Time frame: second week of two week treatment period
Number of Patients With >=50% Pain Reduction (Using the Crossover Comparison Structure of the Study)
Time frame: Assessed at end of two week treatment period
Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (First Treatment Period Only)
Time frame: Assessed at end of two week treatment period
Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only)
Time frame: 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)
Time frame: 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)
Time frame: Assessed at end of two week treatment period
Emotional Functioning (First Treatment Period Only)
Time frame: Assessed at end of two week treatment period
Emotional Functioning (Using the Crossover Comparison Structure of the Study)
Time frame: Assessed at end of two week treatment period
Overall Improvement (First Treatment Period Only)
Time frame: Will be assessed at end of two week treatment period
Overall Improvement (Using the Crossover Comparison Structure of the Study)
Time frame: Will be assessed at end of two week treatment period
Categorical Rating of Pain Intensity (First Treatment Period Only)
Time frame: Assessed at end of two week treatment period
Categorical Rating of Pain Intensity (Using the Crossover Comparison Structure of the Study)
Time frame: Assessed at end of two week treatment period
Breakthrough Treatment (First Treatment Period Only)
Time frame: Assessed during two week treatment period
Breakthrough Treatment (Using the Crossover Comparison Structure of the Study)
Time frame: Assessed during two week treatment period
Missed Medication Dose (First Treatment Period Only)
Time frame: Assessed during two week treatment period
Missed Medication Doses (Using the Crossover Comparison Structure of the Study)
Time frame: Assessed during two week treatment period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian J Wainger, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sulfasalazine in people with Painful Neuropathy, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score (First Treatment Period) (time frame: second week of two week treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2018.