Evaluate the Efficacy and Safety of Goofice® (Elobixibat) in Patients With Chronic Constipation

NCT05895877 | Unknown Phase 3 DMC

• 1 other identifier: SYN-ELO-001
• Study Type: interventional
• Target: 351
• Locations: 1 country
• Sites: 1

Brief Summary

This is a double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of Goofice® in patients with chronic constipation.

Conditions

Constipation

Outcome Measures

Primary Outcomes (1)

• Overall Complete spontaneous bowel movement(CSBM) responder rate during 12 weeks treatment

  * An overall CSBM responder is a subject who is a weekly CSBM responder for at least 9 of the 12 treatment weeks, including at least 3 of the last 4 treatment weeks. * A weekly CSBM responder will be defined as a subject with CSBM frequency of ≥ 3 times and CSBM frequency improved by ≥ 1 time from Week -1 of the screening period. * SBM is defined as defecation without laxative drug/enema or stool extraction. CSBM is defined as SBM without sensation of incomplete evacuation. In this study, when subjects used laxative drug at the day before initiation of screening period or rescue medication after initiation of screening period, defecation within 24 hours after the use of these medications will be not deemed as SBM or CSBM.

  12 weeks

Secondary Outcomes (8)

• Efficacy endpoint - Complete spontaneous bowel movement (CSBM) responder rate at Week 12

  12 weeks

• Efficacy endpoint - Spontaneous bowel movement (SBM) responder rate at Week 12

  12 weeks

• Efficacy endpoint - SBM and CSBM responder rate

  4 weeks

• Efficacy endpoint - SBM frequency

  12 weeks

• Efficacy endpoint - CSBM frequency

  12 weeks

Study Arms (2)

Goofice®

ACTIVE COMPARATOR

Active ingredient: Elobixibat 5mg/tab Dosage and Frequency: Once daily before breakfast. The starting dose is total 10 mg of Goofice® (2 tablets). After 7 days of the start of the study treatment, the dosage may be adjusted according to symptoms among the dose levels of 5, 10, and 15 mg.However, the maximum daily dose is 15 mg (3 tablets).

Drug: Goofice®

Goofice® Placebo

PLACEBO COMPARATOR

Active ingredient/Excipients: The placebo drug is identical in appearance to the Goofice ® tablet with the same excipient ingredients, but without the active compound. Dosage and Frequency: Once daily before breakfast. The dosage and frequency is the same as active drug

Drug: Goofice® Placebo

Interventions

Goofice® DRUG

Once daily before breakfast.

Goofice®

Goofice® Placebo DRUG

Once daily before breakfast.

Goofice® Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- At provisional enrollment
• Men or women ≥ 20 years of age.
• Include 2 or more of the following during the last 3 months with symptom onset of at least 6 months:
• Straining during more than 25% of bowel movements (BMs);)
• Lumpy or hard stools in 25% of BMs;
• Sensation of incomplete evacuation in more than 25% of all BMs;
• Sensation of anorectal blockage or obstruction in more than 25% of BMs;
• Manual maneuvers required in more than 25% of BMs;
• Fewer than 3 BMs per week.
• In addition to having at least 2 of the above criteria, the following must also apply:
• a. Loose stools are rarely present without the use of laxatives; b. Insufficient criteria for irritable bowel syndrome (IBS).
• Ability to provide written consent. - At time of enrollment
• A total of SBM frequencies \< 6 times during the 2-week screening period.

You may not qualify if:

• At provisional enrollment
• Known or suspected allergy to components in elobixibat.
• Known or suspected organic constipation.
• Known or suspected symptomatic or drug-induced constipation.
• Known or suspected slow colon transit type constipation.
• Known or suspected excretory disorder constipation.
• Currently have or history of gastrointestinal obstruction.
• Currently have or history of abdominal hernia.
• History of laparotomy other than simple appendectomy.
• History of cholecystectomy or surgical or endoscopic intervention related to papillotomy.
• Subjects in whom the dosage regimens of medications, of which changing the dosage regimens is prohibited, will be changed after the day of informed consent.
• Cannot use the rescue medication (bisacodyl suppositories 10 mg).
• Pregnant, lactating or potentially pregnant women, women who wish to become pregnant from the time of the informed consent to the last observation/test point, or women who do not agree to use appropriate birth control methods. The acceptable effective contraception methods include: a. Male or female sterilization, implant, or intrauterine device; b. Injectable, pill, patch, ring plus one barrier method\*; c. Two combined barrier methods\*.
• Effective barrier methods are diaphragm, male or female condoms, sponge, or spermicides (creams or gels that contain a chemical to kill sperm).
• Anemia, defined as hemoglobin ≤ 10 g/dL.

Sponsors & Collaborators

• Synmosa Biopharma Corp.: lead

Study Sites (1)

National Taiwan University Hospital Clinical Trial Center

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ming-Shiang Wu

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yayoi Lai

CONTACT

886-2-87977100; yayoi1413@synmosa.com.tw

Vincent Hsieh

CONTACT

886-2-87977100; vincent1132@synmosa.com.tw

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2022
• First Posted: June 9, 2023
• Study Start: December 21, 2021
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: June 9, 2023

Record last verified: 2022-09

Locations

TW (1)