Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase III Study to Evaluate the Efficacy and Safety of ASP0456 in Patients With Constipation Predominant Irritable Bowel Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02316899
Recruitment Status : Completed
First Posted : December 15, 2014
Last Update Posted : December 18, 2019
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
The objective of this study is to evaluate the efficacy and safety of ASP0456 in patients with constipation predominant irritable bowel syndrome (IBS-C).

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome With Constipation (IBS-C) Drug: linaclotide Drug: Placebo Phase 3

Detailed Description:

<Period I (double-blind period)> A multicenter, collaborative, double-blind, parallel comparative study is conducted using IBS-C patients as subjects to verify efficacy of ASP0456 and examine the safety. After the 2-week bowel habit observation period, subjects satisfying the primary enrollment criteria are randomly allocated to either ASP0456 group or placebo group, and orally administered the drug or placebo once daily before breakfast for 12 weeks.

<Period II (non-blind period)> A multicenter, collaborative, non-blind, non-controlled study is conducted to examine safety and efficacy of ASP0456 in long-term administration in IBS-C patients. After Period I, subjects satisfying the transfer criteria are orally administered ASP0456 once daily before breakfast for 40 weeks.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase III Study of ASP0456 - A Double-blind, Placebo-controlled, Parallel-group, Comparative Study and Long-term Study in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
Actual Study Start Date : October 21, 2014
Actual Primary Completion Date : September 19, 2015
Actual Study Completion Date : March 29, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
Experimental: ASP0456 (Period I)
Up to 12 weeks
Drug: linaclotide
Oral administration once daily
Other Name: ASP0456

Placebo Comparator: Placebo (Period I)
Up to 12 weeks
Drug: Placebo
Oral administration once daily

Experimental: ASP0456 (Period II)
From 12 weeks to 52 weeks
Drug: linaclotide
Oral administration once daily
Other Name: ASP0456




Primary Outcome Measures :
  1. Responder rate of Global assessment of relief of IBS symptoms during 12 weeks. [ Time Frame: During 12 weeks ]
    The responder of the evaluation items during the 12 weeks shall be the subject satisfying weekly responder of the evaluation items for over 6 weeks of the 12 weeks.

  2. Responder rate of CSBM during 12 weeks [ Time Frame: During 12 weeks ]
    CSBM: Complete Spontaneous Bowel Movement. The responder of the evaluation items during the 12 weeks shall be the subject satisfying weekly responder of the evaluation items for over 6 weeks of the 12 weeks.


Secondary Outcome Measures :
  1. Responder rate of SBM during 12 weeks [ Time Frame: During 12 weeks ]
    SBM: Spontaneous Bowel Movement

  2. Responder rate of Abnormal bowel habits improvement during 12 weeks [ Time Frame: During 12 weeks ]
  3. Responder rate of Abdominal pain/discomfort relief during 12 weeks [ Time Frame: During 12 weeks ]
  4. Weekly responder rate of Global assessment of relief of IBS symptoms [ Time Frame: Up to 52 weeks ]
    The weekly responder of the evaluation items shall be the subject satisfying the followings at the time of evaluation in each week.Score of Global assessment of relief of IBS symptoms (7 scores: 1-7) is 1 or 2

  5. Weekly responder rate of CSBM [ Time Frame: Up to 52 weeks ]
    Weekly responder of CSBM: The weekly mean value of CSBM frequency is more than 3 and over 1 more than the weekly mean value of CSBM frequency in the bowel habit observation period

  6. Weekly responder rate of SBM [ Time Frame: Up to 52 weeks ]
    Weekly responder of SBM: The weekly mean value of SBM frequency is more than 3 and over 1 more than the weekly mean value of SBM frequency in the bowel habit observation period

  7. Weekly responder rate of Abnormal bowel habits improvement [ Time Frame: Up to 52 weeks ]
    Score of abdominal bowel habits improvement effect (7 scores: 1-7) is 1 or 2

  8. Weekly responder rate of Abdominal pain/discomfort relief [ Time Frame: Up to 52 weeks ]
    Score of abdominal pain/discomfort improvement effect (7 scores: 1-7) is 1 or 2.

  9. Changes in weekly average of SBM frequency, CSBM frequency, stool form scores, abdominal pain/discomfort severity, abdominal bloating severity, and straining severity. [ Time Frame: From baseline to every week until 52 weeks ]
  10. Changes in IBS-QOL-J scores (entire scores or scores on the sub-scales) [ Time Frame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 40, 52 ]
    IBS-QOL-J: Irritable bowel syndrome quality of life Japanese version

  11. Percentage of subjects with SBM within 24 hours after start of the initial administration [ Time Frame: Up to 24 hours ]
  12. Percentage of subjects with CSBM within 24 hours after start of the initial administration [ Time Frame: Up to 24 hours ]
  13. Safety assessed by development of incidence of adverse events, vital signs, and clinical laboratory tests [ Time Frame: Up to 52 weeks ]


Information from the National Library of Medicine

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 this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who had abdominal pain or discomfort repeatedly for at least 3 days per month during the 3 months before screening examination associated with at least 2 out of the following 3 conditions: (1) Improvement with defecation; (2) Onset associated with a change in frequency of stool; and (3) Onset associated with a change in form (appearance) of stool, and had the above symptom (IBS symptom) 6 months or more before the screening examination period
  • Patients with ≥ 25% of stools hard or lumpy (with each bowel movement occurring without antidiarrheal, laxative, suppository or enema) and <25% of them loose (mushy) or watery during the 3 months before the screening examination
  • Patients who had pancolonoscopy or contrast enema (or sigmoidoscopy) after the onset of IBS symptom and had no organic changes

Exclusion Criteria:

  • Patient with history of surgical resection of stomach, gallbladder, small intestine, or large intestine (excluding resection of appendicitis and benign polyp)
  • Patient with history or current affection of inflammatory bowel disease (Crohn's disease or ulcerative colitis)
  • Patient with history or current affection of ischemic colitis
  • Patient currently affected by infectious enteritis
  • Patient currently affected by hyperthyroidism or hypothyroidism
  • Patient currently affected by active peptic ulcer
  • In the case of a female patient, the one currently affected by endometriosis or uterine adenomyosis
  • Patient with high depression or anxiety considered to influence drug evaluation
  • Patient with history of abuse of drug or alcohol within a year before consent acquisition, or with current abuse
  • Patient who used or underwent or will use or undergo drug/therapy/test prohibited to combine 3 days before the start of bowel habit observation period (Day -17) or thereafter
  • Patient with history or current affection of malignant tumor
  • Patient currently affected by serious cardiovascular disease, respiratory disease, kidney disease, hepatic disease, gastrointestinal disease (excluding IBS), hemorrhagic disease, or neural/mental disease
  • Patient with history of drug allergy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02316899


Locations
Show Show 61 study locations
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Layout table for investigator information
Study Director: Medical Director Astellas Pharma Inc
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT02316899    
Other Study ID Numbers: 0456-CL-0031
First Posted: December 15, 2014    Key Record Dates
Last Update Posted: December 18, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
Keywords provided by Astellas Pharma Inc:
ASP0456
constipation
linaclotide
irritable bowel syndrome (IBS)
Additional relevant MeSH terms:
Layout table for MeSH terms
Irritable Bowel Syndrome
Syndrome
Constipation
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Linaclotide
Guanylyl Cyclase C Agonists
Enzyme Activators
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents