The following trial announcement was noted Jul 25 on MECFS Forums.com. Ketotifen is an H1 antihistamine and “mast cell stabilizer.” Mast cells, found in mucous membranes and connective tissues, release histamine, which is involved in local inflammatory response and immune response to pathogens by making capillaries permeable to white blood cells. Research suggests ketotifen may reduce ‘visceral hypersensitivity’ in IBS patients.]
Indiana University Fibromyalgia Study Seeks Participants
INDIANAPOLIS, Jul 19, 2012: The Indiana University School of Medicine Division of Rheumatology seeks participants for a study of an oral allergy medication to improve the symptoms of fibromyalgia.
The study is open to people age 18 to 65 who have been diagnosed with fibromyalgia.
This federally funded study will require volunteers to make four trips to IU Clinical Research Center [Indianapolis] over a 2.5-month period.
Participants will receive either a placebo or the study medication, ketotifen.
Although oral ketotifen has been available in Canada and in Europe, it is not available in the United States.
However, for this study, the Food and Drug Administration has given its approval to use and test oral ketotifen for patients with fibromyalgia.
Despite the presence of three FDA-approved drugs for fibromyalgia, a majority of patients continue to suffer from persistent pain, disabling fatigue and other symptoms including memory problems, sleep disturbances and irritable bowel symptoms, making it necessary to explore new treatment avenues.
For additional information about the study, contact the Indiana University Clinical Research Center for Fibromyalgia at 317-274-1755 or email firstname.lastname@example.org.
[Note: The principal investigator on this study is pain researcher Dennis Ang, MD, according to ClinicalTrials.gov (Novel Use of (Oral) Ketotifen for the Treatment of Fibromyalgia: A Pilot Study).