NCT02425722

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
383

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

50 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2015

Completed
6 days until next milestone

Study Start

First participant enrolled

April 13, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 24, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2015

Completed
Last Updated

October 18, 2024

Status Verified

October 1, 2024

Enrollment Period

7 months

First QC Date

April 7, 2015

Last Update Submit

October 17, 2024

Conditions

Chronic Constipation

Keywords

linaclotideASP0456chronic constipation

Outcome Measures

Primary Outcomes (1)

  • Change in weekly average of SBM frequency

    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

    From baseline to week 1

Secondary Outcomes (19)

  • Weekly responder rate for SBM

    up to 2 weeks

  • Weekly responder rate for CSBM

    up to 2 weeks

  • Percentage of subjects with SBM within 24 hours after the start of initial treatment

    up to 24 hours

  • Change in weekly average of CSBM frequency

    From baseline to week 1

  • Proportion of subjects with CSBM within 24 hours after the start of initial treatment

    up to 24 hours

  • +14 more secondary outcomes

Study Arms (5)

ASP0456 0.0625mg

EXPERIMENTAL

oral

Drug: ASP0456

ASP0456 0.125mg

EXPERIMENTAL

oral

Drug: ASP0456

ASP0456 0.25mg

EXPERIMENTAL

oral

Drug: ASP0456

ASP0456 0.5mg

EXPERIMENTAL

oral

Drug: ASP0456

Placebo group

PLACEBO COMPARATOR

oral

Drug: Placebo

Interventions

ASP0456DRUG

oral

Also known as: Linaclotide
ASP0456 0.0625mgASP0456 0.125mgASP0456 0.25mgASP0456 0.5mg
PlaceboDRUG

oral

Placebo group

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (50)

Site: 35

Aichi, Japan

Location

Site: 36

Aichi, Japan

Location

Site: 27

Chiba, Japan

Location

Site: 28

Chiba, Japan

Location

Site: 29

Chiba, Japan

Location

Site: 30

Chiba, Japan

Location

Site: 48

Fukuoka, Japan

Location

Site: 49

Fukuoka, Japan

Location

Site: 50

Fukuoka, Japan

Location

Site: 1

Hokkaido, Japan

Location

Site: 2

Hokkaido, Japan

Location

Site: 45

Hyōgo, Japan

Location

Site: 46

Hyōgo, Japan

Location

Site: 47

Hyōgo, Japan

Location

Site: 22

Kanagawa, Japan

Location

Site: 23

Kanagawa, Japan

Location

Site: 24

Kanagawa, Japan

Location

Site: 25

Kanagawa, Japan

Location

Site: 26

Kanagawa, Japan

Location

Site: 44

Kyoto, Japan

Location

Site: 37

Osaka, Japan

Location

Site: 38

Osaka, Japan

Location

Site: 39

Osaka, Japan

Location

Site: 40

Osaka, Japan

Location

Site: 41

Osaka, Japan

Location

Site: 42

Osaka, Japan

Location

Site: 43

Osaka, Japan

Location

Site: 31

Saitama, Japan

Location

Site: 32

Saitama, Japan

Location

Site: 33

Saitama, Japan

Location

Site: 34

Saitama, Japan

Location

Site: 10

Tokyo, Japan

Location

Site: 11

Tokyo, Japan

Location

Site: 12

Tokyo, Japan

Location

Site: 13

Tokyo, Japan

Location

Site: 14

Tokyo, Japan

Location

Site: 15

Tokyo, Japan

Location

Site: 16

Tokyo, Japan

Location

Site: 17

Tokyo, Japan

Location

Site: 18

Tokyo, Japan

Location

Site: 19

Tokyo, Japan

Location

Site: 20

Tokyo, Japan

Location

Site: 21

Tokyo, Japan

Location

Site: 3

Tokyo, Japan

Location

Site: 4

Tokyo, Japan

Location

Site: 5

Tokyo, Japan

Location

Site: 6

Tokyo, Japan

Location

Site: 7

Tokyo, Japan

Location

Site: 8

Tokyo, Japan

Location

Site: 9

Tokyo, Japan

Location

Related Publications (1)

  • Fukudo S, Miwa H, Nakajima A, Kinoshita Y, Kosako M, Nakagawa A, Akiho H, Kuroishi K, Johnston JM, Currie M, Ohkusa T. Dose-finding study of linaclotide in Japanese patients with chronic constipation: A phase II randomized, double-blind, and placebo-controlled study. Neurogastroenterol Motil. 2018 Dec;30(12):e13442. doi: 10.1111/nmo.13442. Epub 2018 Aug 7.

    PMID: 30084233DERIVED

Related Links

MeSH Terms

Interventions

linaclotide

Study Officials

  • Medical Director

    Astellas Pharma Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2015

First Posted

April 24, 2015

Study Start

April 13, 2015

Primary Completion

October 31, 2015

Study Completion

October 31, 2015

Last Updated

October 18, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Shared Documents
STUDY PROTOCOL, SAP, 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.
More information

Locations

JP(50)