This page includes treatment news from IFFGD Industry Council supporters. No endorsement is intended or implied.
Clinical Studies Seeking Participants
A clinical study or trial is a research study to answer specific questions about new therapies or new ways of using known treatments. Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about a study, you or your doctor may contact the study research staff.
Study of Teduglutide for Treatment of Pediatric Short Bowel Syndrome (SBS)
May 31, 2016 – Participants sought for a short bowel syndrome (SBS) research study for children up to 17 years of age on parenteral nutrition. The aim of the study is to increase absorption of nutrients which may result in decreased parenteral support. Learn more
Study of Oral Budesonide for Treatment of Eosinophilic Esophagitis (EoE)
May 10, 2016 – Participants sought for a study in adolescents and adults with eosinophilic esophagitis (EoE) to measure the histologic response and determine if any reduction in dysphagia is achieved. Learn more
Linaclotide Study for IBS-C in Children
March 22, 2016 – Participants sought for a multicenter, randomized, double-blind, placebo-controlled safety and efficacy study of a range of linaclotide doses administered orally to children ages 7 to 17 years, with irritable bowel syndrome with constipation (IBS-C). The purpose of this study is to evaluate the safety and efficacy of linaclotide for the treatment of irritable bowel syndrome with constipation (IBS-C), in children ages 7-17 years. Learn more
Linaclotide Study for FC in Children
March 22, 2016 – Participants sought for a multicenter, randomized, double-blind, placebo-controlled parallel-group, safety and efficacy study of a range of linaclotide doses administered orally to children, ages 6 to 17 years, who fulfill modified Rome III Criteria for child/adolescent functional constipation (FC). The purpose of this study is to evaluate the safety and efficacy of linaclotide for the treatment of functional constipation (FC), in children ages 6-17 years. Learn more
Long-Term Study of SBS
March 3, 2014 – Participants of any age are being sought for a long-term research study of patients with short bowel syndrome (SBS). Learn more
Developments in drug treatments for functional GI and motility disorders.
December 19, 2016 – Linaclotide (Linzess) for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults was approved in Japan. Learn more
January 29, 2016 – Pediatric participants sought for two studies of linaclotide for treatment in children of irritable bowel syndrome with constipation, or IBS-C (ages 7–17) and for functional constipation (ages 6–17). Learn more
December 16, 2015 – The new FDA approved drug, eluxadoline (Viberzi), is available for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in men and women. Learn more
January 5, 2015 – The Japanese Ministry of Health, Labor, and Welfare (MHLW) granted teduglutide (Gattex® in the US; Revestive® in the EU) orphan drug status for the treatment of adult patients with short bowel syndrome (SBS). Learn more
June 30, 2014 – The U.S. Food and Drug Administration (FDA) has approved updated labeling for Gattex® (teduglutide [rDNA origin]) for injection, to include long-term data from adult patients with Short Bowel Syndrome (SBS). Learn more
June 13, 2013 – Linaclotide is now available in Europe (branded as Costella in the EU) to treat irritable bowel syndrome with constipation (IBS-C). Learn more
What are Phases?
Treatment trials or studies are in four phases:
Phase 1 tests a new drug or treatment in a small group to evaluate its safety, determine a safe dosage range, and identify side effects;
Phase 2 expands the study to a larger group of people to see if it is effective and to further evaluate its safety;
Phase 3 expands the study to an even larger group of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely; and
Phase 4 takes place after the drug or treatment has been licensed and marketed to further evaluate it in the general population.