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A Study to Evaluate Dose Responses of Efficacy and Safety of ASP0456 in Patient With Chronic Constipation

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: NCT02425722
Recruitment Status : Completed
First Posted : April 24, 2015
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Study Description
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Brief Summary:
The objective of this study is to investigate dose-responses of efficacy and safety of ASP0456 in patients with chronic constipation (diagnosed by Rome III criteria of functional constipation (FC), not including constipation due to organic diseases) compared to placebo and to find the appropriate dose for P3 study.

Condition or disease Intervention/treatment Phase
Chronic Constipation Drug: ASP0456 Drug: Placebo Phase 2

Detailed Description:

To determine optimum dose of ASP0456 for the patients with chronic constipation (not including constipation due to organic diseases) in Japan based on its efficacy and safety, multicentered, placebo-controlled, double-blind, parallel group comparative study will be conducted.

After two-week observation period, the patient who meets the primary registration criteria will be randomized to the one from five groups and will start treatment period. The patients will take once daily orally before the breakfast for two weeks.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 383 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II Study of ASP0456 - A Double-blind, Placebo-controlled, Parallel-group, Comparative Study in Patients With Chronic Constipation (Not Including Constipation Due to Organic Diseases)
Actual Study Start Date : April 13, 2015
Actual Primary Completion Date : October 31, 2015
Actual Study Completion Date : October 31, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arms and Interventions
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Arm Intervention/treatment
Experimental: ASP0456 0.0625mg
oral
 Drug: ASP0456
oral
Other Name: Linaclotide
Experimental: ASP0456 0.125mg
oral
 Drug: ASP0456
oral
Other Name: Linaclotide
Experimental: ASP0456 0.25mg
oral
 Drug: ASP0456
oral
Other Name: Linaclotide
Experimental: ASP0456 0.5mg
oral
 Drug: ASP0456
oral
Other Name: Linaclotide
Placebo Comparator: Placebo group
oral
 Drug: Placebo
oral


Outcome Measures
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Primary Outcome Measures :
  1. Change in weekly average of SBM frequency [ Time Frame: From baseline to week 1 ]
    SBM: Spontaneous Bowel Movement. SBM means the defecation without procedure of laxative, suppository, enema, or stool extraction on the day or preceding day of the defecation. SBM frequency is calculated as follows: (the week total number of SBM )/ (the total number of days on which the frequency of SBM is evaluable) x7


Secondary Outcome Measures :
  1. Weekly responder rate for SBM [ Time Frame: up to 2 weeks ]
    The weekly average 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

  2. Weekly responder rate for CSBM [ Time Frame: up to 2 weeks ]
    The weekly average 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

  3. Percentage of subjects with SBM within 24 hours after the start of initial treatment [ Time Frame: up to 24 hours ]
  4. Change in weekly average of CSBM frequency [ Time Frame: From baseline to week 1 ]
  5. Proportion of subjects with CSBM within 24 hours after the start of initial treatment [ Time Frame: up to 24 hours ]
  6. Weekly responder rate of the global assessment of relief of chronic constipation. [ Time Frame: up to 2 weeks ]
    The weekly responder of the evaluation items shall be the subject satisfying the following at the time of evaluation in each week: Score of Global assessment of relief of chronic constipation symptoms (7 scores: 1-7) is 1 or 2

  7. Weekly responder rate of the abdominal bowel habits improvement in chronic constipation. [ Time Frame: up to 2 weeks ]
    Score of abdominal bowel habits improvement effect (7 scores: 1-7) is 1 or 2

  8. Weekly responder rate of abdominal symptom relief of chronic constipation. [ Time Frame: up to 2 weeks ]
    Score of abdominal symptom improvement effect (7 scores: 1-7) is 1 or 2

  9. Score of the global assessment of relief of chronic constipation [ Time Frame: up to 2 weeks ]
    Scores will be measured using a seven-point ordinal score

  10. Changes in IBS-QOL-J scores (entire scores or scores on the sub-scales) [ Time Frame: Week 0, and 2 ]
    IBS-QOL-J: Irritable bowel syndrome quality of life Japanese version

  11. Changes in weekly average of SBM frequency [ Time Frame: From baseline to every week until 2 weeks ]
    SBM: Spontaneous Bowel Movement

  12. Changes in weekly average of CSBM frequency [ Time Frame: From baseline to every week until 2 weeks ]
    CSBM: Complete Spontaneous Bowel Movement

  13. Changes in weekly average of stool form [ Time Frame: From baseline to every week until 2 weeks ]
    Stool form will be measured using seven-point Bristol Stool Form Scale

  14. Changes in weekly average of abdominal bloating severity scores [ Time Frame: From baseline to every week until 2 weeks ]
    Abdominal bloating severity will be measured using a five-point ordinal score

  15. Changes in weekly average of abdominal pain/discomfort severity scores [ Time Frame: From baseline to every week until 2 weeks ]
    Abdominal pain/discomfort severity will be measured using a five-point ordinal score

  16. Changes in weekly average of straining severity scores [ Time Frame: From baseline to every week until 2 weeks ]
    Straining severity will be measured using a five-point ordinal score

  17. Score of the abdominal bowel habits improvement in chronic constipation [ Time Frame: up to 2 weeks ]
    Scores will be measured using a seven-point ordinal score

  18. Score of the abdominal symptom relief of chronic constipation [ Time Frame: up to 2 weeks ]
    Scores will be measured using a seven-point ordinal score

  19. Safety assessed by development of incidence of adverse events, vital signs, clinical laboratory tests and body weight [ Time Frame: up to 2 weeks ]

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

Inclusion Criteria:

  • Patient who had SBM* (Spontaneous bowel movement) less than 3 times per week, more than six months prior to the provisional registration

    • *Defecation without procedure of laxative, suppository, enema, or stool extraction on the day or preceding day of the defecation

  • Patient who was affected with one or more following symptoms before more than six months of provisional registration:

    • 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
  • Loose stools are rarely present without the use of laxatives more than six months prior to the provisional registration.
  • Patients who had pancolonoscopy or contrast enema (or sigmoidoscopy) after the onset of chronic constipation symptom and had no organic changes

Exclusion Criteria:

  • Patient who has met IBS-C diagnostic criteria from Rome III more than six months prior to provisional registration. Meaning that patient who had recurrent abdominal pain or discomfort at least 3 days/month in last 3 months associated with two or more of the following, and patient who was affected with following IBS symptoms more than six months prior to the provisional registration:

    • Improvement with defecation
    • Onset associated with a change in frequency of stool
    • Onset associated with a change in form (appearance) of stool
  • 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 evidence of inflammatory bowel disease (Crohn's disease or ulcerative colitis)
  • Patient with history or current evidence of ischemic colitis
  • Patient currently affected by infectious enteritis
  • Patient currently affected by hyperthyroidism or hypothyroidism
  • Patient with apparent mechanical obstruction (i.e. patient with ileus caused by hernia)
  • Patient with mega colon or mega rectum
  • Patient currently affected by constipation due to anorectal dysfunction
  • Patient currently affected by drug induced constipation.
  • Patient with constipation due to other organic disease
  • Patient currently affected by active peptic ulcer
  • In the case of a female, 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 (however, patient who used or underwent restricted drug/therapy according to Protocol may be enrolled provisionally)
  • Patient with history or current evidence of malignant tumor
  • Patient currently affected by serious cardiovascular disease, respiratory disease, kidney disease, hepatic disease, gastrointestinal disease (excluding CC), hemorrhagic disease, or neural/mental disease
  • Patient with history of drug allergy
Contacts and Locations
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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): NCT02425722


Locations
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Sponsors and Collaborators
Astellas Pharma Inc
Investigators
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Study Director: Medical Director Astellas Pharma Inc
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT02425722    
Other Study ID Numbers: 0456-CL-1021
First Posted: April 24, 2015    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Access Criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
URL: https://www.clinicalstudydatarequest.com
Keywords provided by Astellas Pharma Inc:
linaclotide
ASP0456
chronic constipation
Additional relevant MeSH terms:
Layout table for MeSH terms
Constipation
Signs and Symptoms, Digestive
Linaclotide
Guanylyl Cyclase C Agonists
 Enzyme Activators
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents