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Trial record 6 of 213 for:    chronic constipation

A Study of Oral Dosing of ASP0456 in Patients 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: NCT02809105
Recruitment Status : Completed
First Posted : June 22, 2016
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
The objective of this study is to verify the efficacy and investigate the safety of the study drug when ASP0456 is administered orally for 4 weeks and 52 weeks.

Condition or disease Intervention/treatment Phase
Chronic Constipation Drug: linaclotide Drug: Placebo Phase 3

Detailed Description:
This study consists of two parts. In Part I, ASP0456 or placebo will be administered orally in a blind manner. In Part II, the long-term safety and efficacy of ASP0456 will be evaluated in patients who have participated in the study and completed the Part I.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase 3 Study of ASP0456 - A Double-blind, Placebo-controlled, Parallel-group, Comparative Study and an Open-label, Uncontrolled, Long-term Dosing Study in Patients With Chronic Constipation (Not Including Constipation Due to Organic Diseases) -
Actual Study Start Date : June 24, 2016
Actual Primary Completion Date : November 14, 2016
Actual Study Completion Date : November 10, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
Experimental: Part I ASP0456
ASP0456 will be administered orally for 4 weeks.
Drug: linaclotide
Oral administration once daily
Other Name: ASP0456

Placebo Comparator: Part I Placebo
Placebo will be administered orally for 4 weeks.
Drug: Placebo
Oral administration once daily

Experimental: Part II ASP0456
ASP0456 will be administered orally.
Drug: linaclotide
Oral administration once daily
Other Name: ASP0456




Primary Outcome Measures :
  1. Change from baseline in weekly mean SBM frequency during one week of administration (Part I) [ Time Frame: Baseline and Week 1 ]
    SBM: Spontaneous bowel movement


Secondary Outcome Measures :
  1. Change from baseline in weekly mean SBM frequency [ Time Frame: Baseline and up to Week 56 ]
  2. Weekly responder rate of SBM [ Time Frame: Baseline and up to Week 56 ]
    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.

  3. Percentage of subjects with SBM within 24 hours after the start of the initial administration [ Time Frame: Up to 24h ]
  4. Time to first SBM [ Time Frame: Up to Week 4 ]
  5. Change from baseline in weekly mean CSBM frequency [ Time Frame: Baseline and up to Week 56 ]
    CSBM: SBM without a sensation of incomplete evacuation

  6. Weekly responder rate of CSBM [ Time Frame: Baseline and up to Week 56 ]
    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.

  7. Percentage of subjects with CSBM within 24 hours after the start of the initial administration [ Time Frame: Up to 24h ]
  8. Change from baseline in weekly mean stool form score [ Time Frame: Baseline and up to Week 56 ]
    Stool form will be measured using seven-point Bristol Stool Form Scale.

  9. Change from baseline in weekly mean abdominal bloating severity score [ Time Frame: Baseline and up to Week 56 ]
    Abdominal bloating severity will be measured using a five-point ordinal score.

  10. Change from baseline in weekly mean abdominal pain/discomfort severity score [ Time Frame: Baseline and up to Week 56 ]
    Abdominal pain/discomfort severity will be measured using a five-point ordinal score.

  11. Change from baseline in weekly mean straining severity score [ Time Frame: Baseline and up to Week 56 ]
    Straining severity will be measured using a five-point ordinal score.

  12. Weekly responder rate of global assessment of relief of CC symptoms [ Time Frame: Up to Week 56 ]
    CC: chronic constipation; 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.

  13. Weekly responder rate of abnormal bowel habits improvement in CC [ Time Frame: Up to Week 56 ]
    Score of abdominal bowel habits improvement effect (7 scores: 1-7) is 1 or 2.

  14. Weekly responder rate of abdominal symptoms relief of CC [ Time Frame: Up to Week 56 ]
    Score of abdominal symptom improvement effect (7 scores: 1-7) is 1 or 2.

  15. Change from baseline in IBS-QOL-J score [ Time Frame: Baseline and up to Week 56 ]
    IBS-QOL-J: Japanese version of Irritable Bowel Syndrome Quality of Life

  16. Safety assessed by incidence of adverse events [ Time Frame: Up to Week 56 ]
  17. Number of participants with abnormal Vital signs and/or adverse events during treatment period [ Time Frame: Up to Week 56 ]
  18. Number of participants with abnormal Laboratory values and/or adverse events during treatment period [ Time Frame: Up to Week 56 ]
  19. Safety assessed by body weight [ Time Frame: Up to Week 56 ]


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.


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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:

  • Patients with SBM frequency for < 3 times/week, since ≥ 6 months prior to preliminary enrollment
  • Patients with one or more related symptoms for ≥ 6 months prior to preliminary enrollment
  • Patients at whom loose (mushy) or watery stools are rarely present without the use of laxatives for ≥ 6 months prior to preliminary enrollment
  • Patients who underwent pancolonoscopy or contrast enema after development of the CC symptoms and within 5 years prior to preliminary enrollment, and in whom no organic change was observed which dose not influence on CC symptoms
  • Female patients must be either:

If of non-childbearing potential:

  • Post-menopausal at the preliminary enrollment, or documented surgically sterile Or, if of childbearing potential,
  • Agree not to try to become pregnant during the study and for 28 days after the final study drug administration
  • And have a negative urine pregnancy test at screening
  • And, if heterosexually active, agree to consistently use two forms of highly effective birth control throughout the study period and for 28 days after the final study drug administration

    • Female patients must agree not to breastfeed throughout the study period and for 28 days after the final study drug administration
    • Female patients must not donate ova starting throughout the study period and for 28 days after the final study drug administration
    • Male subject and their female spouse/partners who are of childbearing potential must be using two forms of highly effective form of birth control starting at Screening and continue throughout the study period, and for 28 days after the final study drug administration
    • Male subject must not donate sperm starting at Screening and throughout the study period and, for 28 days after the final study drug administration

Exclusion Criteria:

  • Patients who have met the Rome III diagnostic criteria for IBS; with recurrent abdominal pain or discomfort for ≥ 3 days/month in the last 3 months prior to preliminary enrollment, associated with ≥ 2 of the 3 characteristics described below and with the symptoms (IBS symptoms) described above for ≥ 6 months prior to preliminary enrollment

    1. Improvement with defecation
    2. Onset associated with a change in frequency of stool
    3. Onset associated with a change in form (appearance) of stool
  • Patients with a history of surgical resection of the stomach, gallbladder, small intestine, or large intestine
  • Patients with a history or current evidence of inflammatory bowel disease or ischemic colitis
  • Patients with concurrent infectious enteritis, hyperthyroidism or hypothyroidism, constipation due to anorectal dysfunction, drug-induced constipation, constipation due to other organic diseases or active peptic ulcer
  • Patients with apparent mechanical obstruction
  • Patients with megacolon or megarectum
  • For female patients, patients with concurrent endometriosis or adenomyosis
  • Patients who are considered to have severe depression or a severe anxiety disorder that can affect the efficacy evaluation of the study drug
  • Patients with a history of abuse of drugs or alcohol, or current abuse of drugs or alcohol
  • Patients who used/underwent or are scheduled to use/undergo prohibited concomitant drugs or therapies, or in whom prohibited examinations were conducted or are scheduled to be conducted 3 days prior to the start of the bowel habit observation period
  • Patients with a history or current evidence of malignant tumors
  • Patients with concurrent serious cardiovascular diseases, respiratory diseases, renal diseases, hepatic diseases, gastrointestinal disorders, blood diseases, or neurological/psychiatric diseases
  • Patients with a history of drug allergies
  • Patients who have participated in the clinical trial of ASP0456 or have been administered ASP0456
  • Patients who have participated or are participating in another clinical trial or post-marketing clinical study of other ethical drugs or medical devices within 12 weeks prior to obtaining informed consent

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): NCT02809105


Locations
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Sponsors and Collaborators
Astellas Pharma Inc
Investigators
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Study Director: Medical Director Astellas Pharma Inc
Additional Information:
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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT02809105    
Other Study ID Numbers: 0456-CL-1031
First Posted: June 22, 2016    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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Astellas Pharma Inc:
Chronic constipation
Linaclotide
ASP0456
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive
Linaclotide
Guanylyl Cyclase C Agonists
Enzyme Activators
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents