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An Open-Label, Long-term Study to Assess the Immunogenicity of Linaclotide Administered Orally to Adult Patients With Irritable Bowel Syndrome With Constipation or Chronic Idiopathic Constipation

Sponsored by Forest Laboratories

Phase Quota
Phase 4

The primary objective of this study is to assess the potential of linaclotide treatment to induce the development of anti-drug antibodies (ADAs). The secondary objectives are to provide additional evidence supporting the long-term safety and efficacy of linaclotide in adult irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) patients and to evaluate lower doses of linaclotide.

Study Start Date: November 2015

Estimated Completion Date: March 2018

Specialties: Internal Medicine: Clinical Pharmacology,Gastroenterology Nursing: Gastroenterology Gastroenterology: GI Motility,Pharmacology/kinetics,Small/Large Intestine Family Medicine: Clinical Pharmacology,Gastroenterology Pharmacy: Stomach/GI Physician Assistant: Gastroenterology

Interventions

  • Drug: Linaclotide 145 micrograms
  • Drug: Linaclotide 72 micrograms
  • Drug: Linaclotide 290 micrograms

Inclusion criteria

  • Patients meet the Rome III criteria for IBS-C or CIC:
    • IBS-C Criteria: the patient must meet the following 2 criteria (A and B)
      • IBS Criteria: The patient must have abdominal pain or discomfort at least 3 days per month in the 3 months before diagnosis (with symptom onset at least 6 months before diagnosis) associated with 2 or more of the following:
        • Improvement with defecation
        • Onset associated with a change in frequency of stool
        • Onset associated with a change in form (appearance) of stool
      • Stool Consistency Requirement: During the 3 months before diagnosis in the absence of laxative or enema use, the patient has hard or lumpy stools (Bristol Stool Form Scale [BSFS] score 1 or 2) with at least 25% of BMs and has loose or mushy stools (BSFS 5 or 6) with <25% of BMs
    • CIC Criteria: The patient must meet the following 3 criteria (A, B, and C):
      • Patient meets 2 or more of the following criteria for 3 months before the diagnosis with symptom onset at least 6 months before diagnosis:
        • Straining during at least 25% of defecations
        • Lumpy or hard stools in at least 25% of defecations
        • Sensation of incomplete evacuation for at least 25% of defecations
        • Sensation of anorectal obstruction/blockage for at least 25% of defecations
        • Manual maneuvers to facilitate at least 25% of defecations (eg, digital evacuation, support of the pelvic floor)
        • Fewer than 3 defecations per week
      • Loose stools are rarely present without the use of laxatives
      • Insufficient criteria for irritable bowel syndrome. (The criteria for IBS are provided in Point A under IBS Criteria, above)
  • Patient meets the colonoscopy requirements, which are modified from the Summary of the US-Multi-Society Task Force on Colorectal Cancer and other Colonoscopy Requirements
  • Patient has successfully completed protocol procedures (with no clinically significant findings)

Exclusion criteria

  • At Day 1 visit, the patient reports having 6 or more spontaneous bowel movements (SBMs) in the week prior to screening
  • At Day 1 visit, the patient reports having any SBMs that were watery (BSFS=7) or more than 1 SBM that was mushy (BSFS=6) in the week prior to screening
  • Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility
  • Patient has any protocol excluded or clinically significant medical or surgical history that would limit the patient's ability to complete or participate in this clinical trial or could confound the study assessments
  • Patient has ever received linaclotide as a treatment (including commercially-available product) or has been randomized into any clinical study in which linaclotide was a treatment. (Patients who enrolled into linaclotide clinical studies conducted prior or during this study but failed to be randomized are eligible for the current study)
  • Patient has ever received plecanatide, SP-333, or has participated in a plecanatide clinical study

Study Locations And Contact Information

  • Forest Investigative Site 026, Smithfield Pennsylvania
  • Forest Investigative Site 039, Flint Michigan
  • Forest Investigative Site 069, Woodstock Georgia
  • Forest Investigative Site 076, Tempe Arizona
  • Forest Investigative Site 058, Birmingham Alabama
  • Forest Investigative Site 032, West Des Moines Iowa
  • Forest Investigative Site 020, Laguna Hills California
  • Forest Investigative Site 008, Hialeah Florida
  • Forest Investigative Site 004, St Petersburg Florida
  • Forest Investigative Site 017, Oklahoma City Oklahoma
  • Forest Investigative Site 025, Encinitas California
  • Forest Investigative Site 065, Chandler Arizona
  • Forest Investigative Site 067, Blue Ridge Georgia
  • Forest Investigative Site 046, Glendale Arizona
  • Forest Investigative Site 024, Chapel Hill North Carolina
  • Forest Investigative Site 066, Scottsdale Arizona
  • Forest Investigative Site 021, Iowa City Iowa
  • Forest Investigative Site 014, Greensboro North Carolina
  • Forest Investigative Site 053, Anniston Alabama
  • Forest Investigative Site 072, Denver Colorado
  • Forest Investigative Site 048, Watertown Massachusetts
  • Forest Investigative Site 057, Beavercreek Ohio
  • Forest Investigative Site 080, Jenkintown Pennsylvania
  • Forest Investigative Site 038, Surprise Arizona
  • Forest Investigative Site 043, Winston-Salem North Carolina
  • Forest Investigative Site 074, Fort Myers Florida
  • Forest Investigative Site 078, Tucson Arizona
  • Forest Investigative Site 064, Fountain Valley California
  • Forest Investigative Site 070, Atlanta Georgia
  • Forest Investigative Site 031, Charlottesville Virginia
  • Forest Investigative Site 001, Mission Hills California
  • Forest Investigative Site 037, Cumberland Rhode Island
  • Forest Investigative Site 041, Greenville South Carolina
  • Forest Investigative Site 005, Little Rock Arkansas
  • Forest Investigative Site 077, Hartsdale New York
  • Forest Investigative Site 006, San Diego California
  • Forest Investigative Site 018, Little Rock Arkansas
  • Forest Investigative Site 029, New York New York
  • Forest Investigative Site 036, St. Louis Missouri
  • Forest Investigative Site 023, Orlando Florida
  • Forest Investigative Site 073, Biloxi Mississippi
  • Forest Investigative Site 042, Bryan Texas
  • Forest Investigative Site 040, Kalamazoo Michigan
  • Forest Investigative Site 056, Witchita Kansas
  • Forest Investigative Site 019, Boynton Beach Florida
  • Forest Investigative Site 027, Clive Iowa
  • Forest Investigative Site 016, Lenoir North Carolina
  • Forest Investigative Site 060, Fresno California
  • Forest Investigative Site 054, Irvine California
  • Forest Investigative Site 045, Reno Nevada
  • Forest Investigative Site 003, Brandon Florida
  • Forest Investigative Site 034, Pittsburgh Pennsylvania
  • Forest Investigative Site 035, Pratt Kansas
  • Forest Investigative Site 050, Cincinnati Ohio
  • Forest Investigative Site 015, Port Orange Florida
  • Forest Investigative Site 062, Foley Alabama
  • Forest Investigative Site 007, Natchitoches Louisiana
  • Forest Investigative Site 002, Albuquerque New Mexico
  • Forest Investigative Site 049, Newton Kansas
  • Forest Investigative Site 071, Sacramento California
  • Forest Investigative Site 009, San Diego California
  • Forest Investigative Site 052, Houston Texas
  • Forest Investigative Site 011, Miami Florida
  • Forest Investigative Site 082, Greer South Carolina
  • Forest Investigative Site 028, Garden Grove California
  • Forest Investigative Site 044, Athens Alabama
  • Forest Investigative Site 081, Memphis Tennessee
  • Forest Investigative Site 010, Boise Idaho
  • Forest Investigative Site 055, Oakwood Ohio
  • Forest Investigative Site 022, Rockford Illinois
  • Forest Investigative Site 061, Albuquerque New Mexico
  • Forest Investigative Site 013, Maitland Florida
  • Forest Investigative Site 030, Wichita Kansas
  • Forest Investigative Site 079, Plano Texas
  • Forest Investigative Site 051, San Antonio Texas
  • Forest Investigative Site 075, Corona California
  • Forest Investigative Site 083, Hialeah Florida
  • Forest Investigative Site 063, Philadelphia Pennsylvania
  • Forest Investigative Site 047, North Massapequa New York
  • Forest Investigative Site 059, Upland California
  • Forest Investigative Site 068, Sacramento California
  • Forest Investigative Site 012, Brandenton Florida
  • Forest Investigative Site 033, Weymouth Massachusetts

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