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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.)


 

IBS-C and Functional Constipation

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)


Purpose of Study
: 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.

This study includes up to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period. Patients age 7-11 will receive oral liquid or oral solid capsule and patients 12-17 will receive solid oral capsule formulation. Children ages 7-11 years meeting the entry criteria will be randomized to 1 of 3 doses of linaclotide or placebo for 4 weeks. Children ages 12-17 years meeting the entry criteria will be randomized to 1 of 4 doses of linaclotide or placebo for 4 weeks.

This 4-week study will assess the effects of linaclotide on bowel movement frequency, as well as other bowel symptoms of IBS-C.

Sponsor: Forest Laboratories

Study Population: Male and female patients ages 7 years to 17 years who meet inclusion criteria, including Rome III symptom criteria for child/adolescent IBS and for modified Rome III criteria for child/adolescent functional constipation.

Phase: Phase 2

Contact: For more information visit www.marco-polostudies.com or phone 888-609-3456.

Verified January 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)


Purpose of study
: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. This study includes up to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period. Patients age 6-11 will receive oral liquid formulation and patients 12-17 will receive solid oral capsule or liquid oral solution.

Children ages 6-11 years meeting the entry criteria will be randomized to 1 of 3 doses of linaclotide or placebo for 4 weeks. Children ages 12-17 years meeting the entry criteria will be randomized to 1 of 4 doses of linaclotide or placebo for 4 weeks. This 4-week study will assess the effects of linaclotide on bowel movement frequency, as well as other bowel symptoms of FC.

Sponsor: Forest Laboratories

Study Population: Male and female patients ages 6 years to 17 years who meet inclusion criteria, including Rome III symptom criteria for child/adolescent functional constipation (FC).

Phase: Phase 2

Contact: For more information visit www.marco-polostudies.com or phone 888-609-3456.

Verified January 2015

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

Purpose of study: This 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.

Phase: Phase 1

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

Verified January 2015

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

Verified January 2015

Seeking Participants with Chronic Idiopathic Constipation for Trial of Linaclotide

Purpose of study: This 12-week, Phase 3 study will assess the efficacy and safety of linaclotide in patients with chronic idiopathic constipation (CIC).

Sponsor: Ironwood Pharmaceuticals, Inc.

Collaborator: Forest Laboratories

Participation: Eligible male and female patients demonstrating CIC aged 18 and older

Contacts: Find a recruiting location near you at ClinicalTrials.gov.

Verified January 2015

Recruiting for a Study on the Efficacy and Safety of Linaclotide for Opioid-Induced Constipation

Purpose of study: This 8-week, Phase 2, multicenter study will evaluate the safety and efficacy of linaclotide for the treatment of opioid-induced constipation (OIC) in adults receiving opioid treatment for chronic non-cancer pain.

Sponsor: Forest Laboratories

Collaborator: Ironwood Pharmaceuticals, Inc.

Participation: Eligible male and female patients 18 years and older who have presented chronic non-cancer pain for a minimum of 3 months and are receiving a stable dose of opioid treatment for at least 4 days.

Contacts: Kathy Hynek, phone: 866-369-5227, email: kathy.hynek@frx.com; Be sure to refer to this study by its ClinicalTrials.gov identifier: NCT02270983

Verified January 2015

 

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, 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

Verified January 2015

 

Short Bowel Syndrome (SBS)

Patients with SBS Sought for Long-term Study

Purpose of 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.

Sponsor: NPS Pharmaceuticals, Inc.

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

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

Verified January 2015

 

Congenital Sucrase-Isomaltase Deficiency (CSID)

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.

Sponsor: QOL Medical, LLC

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

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

 Verified January 2015

Barrett's Esophagus

Recruiting for Study on the Effects of Dexlansoprazole on Recurrent Intestinal Metaplasia in Patients with Erradicated Barrett's Esophagus

Purpose of study: The primary purpose of this Phase 4 study is to evalute the effect of dexlansoprazole QD and BID on the recurrence of intestinal metaplasia in patients who have acheived complete eradication of Barrett's esophagus with high-grade dysplasia (HGD) following radiofrequency ablation (RFA).

Participation: Eligible males or females 18 to 80 years of age

Sponsor: Takeda

Contact: Takeda Study Registration Call Center, phone: 800-778-2860, email: medicalinformation@tpna.com; Please refer to this study by its ClinicalTrials.gov identifier: NCT02162758

 Verified January 2015

Last modified on April 6, 2016 at 12:54:31 PM