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

NCT ID: NCT02425722

Last Updated: 2024-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 383 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-13
• Study Completion Date: 2015-10-31

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.

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.

Conditions

Chronic Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ASP0456 0.0625mg

oral

Group Type: EXPERIMENTAL

ASP0456

Intervention Type: DRUG

oral

ASP0456 0.125mg

oral

Group Type: EXPERIMENTAL

ASP0456

Intervention Type: DRUG

oral

ASP0456 0.25mg

oral

Group Type: EXPERIMENTAL

ASP0456

Intervention Type: DRUG

oral

ASP0456 0.5mg

oral

Group Type: EXPERIMENTAL

ASP0456

Intervention Type: DRUG

oral

Placebo group

oral

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

oral

Interventions

ASP0456

oral

Intervention Type: DRUG

Placebo

oral

Intervention Type: DRUG

Other Intervention Names

Linaclotide

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Inc

Locations

Site: 35

Aichi, , Japan

Site: 36

Aichi, , Japan

Site: 27

Chiba, , Japan

Site: 28

Chiba, , Japan

Site: 29

Chiba, , Japan

Site: 30

Chiba, , Japan

Site: 48

Fukuoka, , Japan

Site: 49

Fukuoka, , Japan

Site: 50

Fukuoka, , Japan

Site: 1

Hokkaido, , Japan

Site: 2

Hokkaido, , Japan

Site: 45

Hyōgo, , Japan

Site: 46

Hyōgo, , Japan

Site: 47

Hyōgo, , Japan

Site: 22

Kanagawa, , Japan

Site: 23

Kanagawa, , Japan

Site: 24

Kanagawa, , Japan

Site: 25

Kanagawa, , Japan

Site: 26

Kanagawa, , Japan

Site: 44

Kyoto, , Japan

Site: 37

Osaka, , Japan

Site: 38

Osaka, , Japan

Site: 39

Osaka, , Japan

Site: 40

Osaka, , Japan

Site: 41

Osaka, , Japan

Site: 42

Osaka, , Japan

Site: 43

Osaka, , Japan

Site: 31

Saitama, , Japan

Site: 32

Saitama, , Japan

Site: 33

Saitama, , Japan

Site: 34

Saitama, , Japan

Site: 10

Tokyo, , Japan

Site: 11

Tokyo, , Japan

Site: 12

Tokyo, , Japan

Site: 13

Tokyo, , Japan

Site: 14

Tokyo, , Japan

Site: 15

Tokyo, , Japan

Site: 16

Tokyo, , Japan

Site: 17

Tokyo, , Japan

Site: 18

Tokyo, , Japan

Site: 19

Tokyo, , Japan

Site: 20

Tokyo, , Japan

Site: 21

Tokyo, , Japan

Site: 3

Tokyo, , Japan

Site: 4

Tokyo, , Japan

Site: 5

Tokyo, , Japan

Site: 6

Tokyo, , Japan

Site: 7

Tokyo, , Japan

Site: 8

Tokyo, , Japan

Site: 9

Tokyo, , Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 30084233 (View on PubMed)

Related Links

https://astellasclinicalstudyresults.com/study.aspx?ID=279

Link to results on the Astellas Clinical Study Results website

Other Identifiers

0456-CL-1021

Identifier Type: -

Identifier Source: org_study_id