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Industry Sponsored Clinical Trials and Studies


A clinical study or trial is a research study to answer specific questions about new therapies or new ways of using known treatments. Clinical studies/trials test potential treatments in human volunteers to see if they should be approved for wider use in the general population.

Why Participate in a Clinical Trial?

Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research. (Find out more including answers to frequently asked questions in this Guide to Randomized Clinical Trials.)

Trials Seeking Participants

Seeking Women Who are Breastfeeding or Pumping and are Taking Linaclotide for IBS-C or CIC

Purpose of study: This Phase 1 study will determine the amount of linaclotide in breast milk after once daily doses of the drug over 4 consecutive days.

Sponsor: Forest Laboratories

Participation: Eligible female patients currently taking linaclotide for constipation predominant irritable bowel syndrome (IBS-C) or chronic idiopathic constipation (CIC) who have been actively breastfeeding or pumping for at least 4 weeks.

Location: Iowa City, Iowa

Contacts: Sandra Beaird, Pharm.D. Phone: 1-800-678-1605, ext 66297; Be sure to refer to this study by its ClinicalTrials.gov identifier: NCT02220348

Participants Sought for Study of SBI for Patients with IBS-D Following Successful Treatment of SIBO with Rifaximin

Purpose of study: This study will evaluate whether the use of serum-derived bovine immunoglobulin protein isolate (SBI) as a medical food will lead to greater management of symptoms of diarrhea predominant irritable bowel syndrome (IBS-D) in patients with small intestinal bacterial overgrowth (SIBO) after successful treatment with the antibiotic rifaximin.

SBI is the main ingredient in EnteraGam, a prescription medical food for the dietary management of patients with enteropathy or chronic loose or frequent stools, including patients with IBS-D.

Sponsor: Cedars-Sinai Medical Center

Collaborator: Entera Health, Inc.

Participation: Eligible male and female patients aged 18 to 75 with IBS-D who have recently completed treatment for SIBO with the antibiotic rifaximin.

Location: Los Angeles, California

Contacts: Shari Chua, phone: 310-423-3792; Be sure to refer to this study by its ClinicalTrials.gov identifier: NCT02251483

Seeking Participants for Study of Linaclotide for Patients with IBS-C

Purpose of study: This 12-Week, Phase 3, international, multicenter study will evaluate the effectiveness and safety of linaclotide in adult patients with constipation predominant irritable bowel syndrome (IBS-C).

Sponsor: AstraZeneca

Collaborator: Ironwood Pharmaceuticals, Inc.

Participation: Eligible male and female patients aged 18 and older

Location: China, Australia, and New Zealand

Contacts: Lennie Wu, phone: 86-2038183761; Be sure to refer to this study by its ClinicalTrials.gov identifier: NCT01880424

Participants Sought for Study of Linaclotide’s Effect on Bi-directional Brain and Gut Axis in IBS-C Patients

Purpose of study: This study will assess how Linaclotide affects bowel function and abdominal pain in patients with irritable bowel syndrome with constipation (IBS-C). It will also examine effects of the drug on communication between the brain and the pelvic-floor region.

Sponsor: Georgia Regents University

Collaborator: Forest Laboratories

Participation: Eligible male and female patients aged 18–64 years

Location: Augusta, Georgia

Contacts: Amanda Schmeltz, BA, phone: 706-721-1968, email: aschmeltz@gru.edu or Satish Rao, MD, phone: 706-721-2238; Be sure to refer to this study by its ClinicalTrials.gov identifier: NCT02078323

Patients with SBS Sought for Long-term Study

This global clinical study has begun enrolling patients with short bowel syndrome (SBS) in order to provide additional long-term data on safety of teduglutide and on the natural history of SBS in patients in routine, real world settings. The information gathered is intended to assist health care providers in optimizing their clinical decisionmaking in managing SBS patients.

Enrollment will include SBS patients treated and not treated with teduglutide.

Study Population: Male and female patients of any age with a diagnosis of SBS, including those who have never taken teduglutide, as well those who have or are using teduglutide.

Study Follow-up Duration: 10 years

Sponsor: NPS Pharmaceuticals, Inc.

Contact: NPS Clinical Operations, phone: 908-450-5300, email: SBSregistry@quintiles.com; Be sure to refer to this study by its ClinicalTrials.gov identifier: NCT01990040

Two Studies of Lubiprostone in Pediatric Subjects with Functional Constipation

Purpose of study 1: This is a 12-Week study to evaluate the efficacy, safety, and pharmacokinetics of oral lubiprostone as treatment for pediatric patients with functional constipation.

Collaborators: Sucampo Pharma Americas, LLC and Takeda

Participation: Eligible male and female patients aged 6–17 years

Contacts: Shadreck Mareya, PhD, phone: 301-961-3400, email: pedgen@sucampo.com; Be sure to refer to this study by its ClinicalTrials.gov identifier: NCT02042183

 

Purpose of study 2: This is a 9-Month study to evaluate the long-term safety, efficacy, and pharmacokinetics of oral lubiprostone as treatment for pediatric patients with functional constipation.

Collaborators: Sucampo Pharma Americas, LLC and Takeda

Participation: Eligible male and female patients aged 6–17 years

Contacts: Shadreck Mareya, PhD, phone: 301-961-3400, email: pedgen@sucampo.com; Be sure to refer to this study by its ClinicalTrials.gov identifier: NCT02138136

CSID Genetic Prevalence Study in Children With Chronic Diarrhea or Chronic Abdominal Pain

Purpose of study: Determine the prevalence of congenital sucrase-isomaltase deficiency (CSID) genetic variants in subjects 18 years of age or younger with a primary symptom of chronic idiopathic diarrhea or chronic abdominal pain without constipation.

Participation: Eligible males or females 18 years of age or younger experiencing chronic, idiopathic diarrhea or abdominal pain for at least 4 weeks.

Sponsor: QOL Medical, LLC

Collaborators: 19 Medical Centers located throughout the U.S.

Contact: Heather Elser, PhD, phone: 919-832-4949, email: helser@qolmed.com; Please refer to this study by its ClinicalTrials.gov identifier: NCT01914003

 

Ongoing Trials No Longer Seeking Participants

Seeking Participants for Phase 2 Study to Evaluate IW-3718 as Part of Treatment for GERD

Purpose of study: This is meant to assess the effect of IW-3718 as an added treatment to ongoing, once-daily proton pump inhibitor (PPI) treatment for patients who continue to experience symptoms of gastroesophageal reflux disease (GERD).

The ongoing study is no longer recruiting participants.

Sponsor: Ironwood Pharmaceuticals, Inc.

Participation: Eligible male and female patients aged 18–65 years

Locations: various throughout the United States

For More Information: ClinicalTrials.gov identifier: NCT02030925

Study Assess Teduglutide as Treatment for Pediatric SBS

Purpose of study: 12-Week, open label study is evaluating the effectiveness and safety of teduglutide as a treatment for pediatric patients with short bowel syndrome (SBS) on parenteral support.

The ongoing study is no longer recruiting participants.

Sponsor: NPS Pharmaceuticals, Inc.

Participation: Eligible male and female patients aged 1–17 years

For More Information: ClinicalTrials.gov identifier: NCT01952080

 

Last modified on January 22, 2015 at 10:46:58 AM