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

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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

Tracking Information
First Submitted Date  ICMJE December 4, 2014
First Posted Date  ICMJE December 15, 2014
Last Update Posted Date December 18, 2019
Actual Study Start Date  ICMJE October 21, 2014
Actual Primary Completion Date September 19, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2014)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2014)
  • Responder rate of SBM during 12 weeks [ Time Frame: During 12 weeks ]
    SBM: Spontaneous Bowel Movement
  • Responder rate of Abnormal bowel habits improvement during 12 weeks [ Time Frame: During 12 weeks ]
  • Responder rate of Abdominal pain/discomfort relief during 12 weeks [ Time Frame: During 12 weeks ]
  • 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
  • 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
  • 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
  • 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
  • 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.
  • 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 ]
  • 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
  • Percentage of subjects with SBM within 24 hours after start of the initial administration [ Time Frame: Up to 24 hours ]
  • Percentage of subjects with CSBM within 24 hours after start of the initial administration [ Time Frame: Up to 24 hours ]
  • Safety assessed by development of incidence of adverse events, vital signs, and clinical laboratory tests [ Time Frame: Up to 52 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase III Study to Evaluate the Efficacy and Safety of ASP0456 in Patients With Constipation Predominant Irritable Bowel Syndrome
Official Title  ICMJE 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)
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).
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Irritable Bowel Syndrome With Constipation (IBS-C)
Intervention  ICMJE
  • Drug: linaclotide
    Oral administration once daily
    Other Name: ASP0456
  • Drug: Placebo
    Oral administration once daily
Study Arms  ICMJE
  • Experimental: ASP0456 (Period I)
    Up to 12 weeks
    Intervention: Drug: linaclotide
  • Placebo Comparator: Placebo (Period I)
    Up to 12 weeks
    Intervention: Drug: Placebo
  • Experimental: ASP0456 (Period II)
    From 12 weeks to 52 weeks
    Intervention: Drug: linaclotide
Publications * Fukudo S, Miwa H, Nakajima A, Haruma K, Kosako M, Nakagawa A, Akiho H, Yamaguchi Y, Johnston JM, Currie M, Kinoshita Y. A randomized controlled and long-term linaclotide study of irritable bowel syndrome with constipation patients in Japan. Neurogastroenterol Motil. 2018 Dec;30(12):e13444. doi: 10.1111/nmo.13444. Epub 2018 Aug 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 27, 2015)
500
Original Estimated Enrollment  ICMJE
 (submitted: December 11, 2014)
480
Actual Study Completion Date  ICMJE March 29, 2016
Actual Primary Completion Date September 19, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02316899
Other Study ID Numbers  ICMJE 0456-CL-0031
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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."
Responsible Party Astellas Pharma Inc
Study Sponsor  ICMJE Astellas Pharma Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Astellas Pharma Inc
PRS Account Astellas Pharma Inc
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP