Study of Sulfasalazine in Treating Painful Neuropathy
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|ClinicalTrials.gov Identifier: NCT01667029|
Recruitment Status : Recruiting
First Posted : August 17, 2012
Last Update Posted : July 14, 2016
|Condition or disease||Intervention/treatment||Phase|
|Painful Neuropathy||Drug: Sulfasalazine Drug: placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||55 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Single-center, Randomized, Double-blind Clinical Study to Evaluate the Effect of Sulfasalazine on Painful Neuropathy|
|Study Start Date :||May 2013|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||December 2017|
1 g oral twice daily for 2 weeks
Placebo Comparator: placebo
oral placebo pill twice daily for two weeks.
- pain score [ 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 during the second week of the two week treatment period.
- Physical Functioning Score [ Time Frame: Assessed at end of two week treatment period ]Will be assessed using the Brief Pain Inventory Interference and Euroquality of Life metrics
- Emotional Functioning [ Time Frame: Assessed at end of two week treatment period ]Will be assessed by the Beck Depression Inventory metric
- Overall Improvement [ Time Frame: Will be assessed at end of two week treatment period ]Will be assessed using the Patient Global Impression of Change metric
- Categorical rating of pain intensity [ Time Frame: Assessed at end of two week treatment period ]Assessed using description as "none, mild, moderate, or severe"
- Breakthrough Treatment [ Time Frame: Assessed during two week treatment period ]Number of times breakthrough pain medication was taken
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01667029
|Contact: Anthony Lever, BA||617 firstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Anthony Lever, BA 617-726-5186|
|Principal Investigator:||Brian J Wainger, MD, PhD||Massachusetts General Hospital|