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

Last updated: May 29, 2023
Sponsor: Synmosa Biopharma Corp.
Overall Status: Active - Recruiting

Phase

3

Condition

Constipation

Treatment

Goofice®

Goofice® Placebo

Clinical Study ID

NCT05895877
SYN-ELO-001
  • Ages > 20
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • At provisional enrollment
  1. Known or suspected allergy to components in elobixibat.
  2. Known or suspected organic constipation.
  3. Known or suspected symptomatic or drug-induced constipation.
  4. Known or suspected slow colon transit type constipation.
  5. Known or suspected excretory disorder constipation.
  6. Currently have or history of gastrointestinal obstruction.
  7. Currently have or history of abdominal hernia.
  8. History of laparotomy other than simple appendectomy.
  9. History of cholecystectomy or surgical or endoscopic intervention related topapillotomy.
  10. Subjects in whom the dosage regimens of medications, of which changing the dosageregimens is prohibited, will be changed after the day of informed consent.
  11. Cannot use the rescue medication (bisacodyl suppositories 10 mg).
  12. Pregnant, lactating or potentially pregnant women, women who wish to becomepregnant from the time of the informed consent to the last observation/testpoint, or women who do not agree to use appropriate birth control methods. Theacceptable effective contraception methods include: a. Male or femalesterilization, implant, or intrauterine device; b. Injectable, pill, patch, ringplus one barrier method*; c. Two combined barrier methods*.
  • Effective barrier methods are diaphragm, male or female condoms, sponge, orspermicides (creams or gels that contain a chemical to kill sperm).
  1. Anemia, defined as hemoglobin ≤ 10 g/dL.
  2. Concurrent serious renal disease (creatinine ≥ 2.00 mg/dL) or liver disease (total bilirubin ≥ 3.0 mg/dL, or aspartate aminotransferase(AST) or alaninetransaminase(ALT) ≥ 100 U/L).
  3. Concurrent clinical significant heart disease, including uncontrolledhypertension, arrhythmia, or heart failure.
  4. History of serious drug-induced allergy needs emergent medical intervention, suchas anaphylaxis, angioedema, generalized urticaria or bronchospasm.
  5. Subjects have a history of cancer (other than basal cell or squamous cellcarcinoma of the skin) unless the malignancy has been in a complete remissionwithout maintenance chemotherapy for ≥ 5 years prior to the Screening visit.
  6. Subjects who are taking part in another clinical study, or subjects who take partin another clinical study within 12 weeks prior to the day of informed consent.
  7. Loss of weight greater than 5 kg one month before screening visit.
  8. Determined by the investigator to be not suitable for the conduct of the studyfor any other reasons.
  9. Subjects have a barium enema within 7 days of the Screening Visit.
  • At time of enrollment
  1. Subjects have a clinically significant finding on colonoscopy performed asrequired in accordance with the American Gastroenterological Association (AGA)guidelines (within AGA time frames). If polyps are found and biopsied, pathology mustbe reviewed and must be negative for cancer before the subject may be enrolled in thestudy. 23. Used the rescue medication (bisacodyl suppositories 10 mg) at least 6 timesduring the 2-week screening period or subjects who used the rescue medication at least 3 times in Week -1 of the screening period. 24. Used the rescue medication for lessthan 72 hours after bowel movement during the 2-week screening period. 25. Mushy stoolor watery stool (Bristol Stool Form Scale type 6 or 7) in SBM during the 2-weekscreening period. 26. Used prohibited medications/therapies during the 2-weekscreening period

Study Design

Total Participants: 351
Treatment Group(s): 2
Primary Treatment: Goofice®
Phase: 3
Study Start date:
December 21, 2021
Estimated Completion Date:
September 30, 2023

Study Description

In order to enroll appropriate patients with chronic constipation, a 2-week constipation-related symptom intensity screening period will be established to investigate the number of bowel movements just prior to the study drug treatment initiation. Eligible subjects who fulfill all selection criteria for enrollment will be randomly assigned to receive Goofice® or placebo drug with 2:1 allocation ratio. The study drug will be received once daily approximately 30 minutes before breakfast in the 12-week treatment period. The starting dosing of Goofice® / placebo will be 10 mg (2 tablets) in treatment period. It is allowed to adjust the dosage among 5, 10, and 15 mg after 7 days after treatment initiation, if the dose adjusting criteria are met depending on symptoms. After treatment period, subjects will be followed up for 4 weeks to observe the effect of discontinuing treatment.

Connect with a study center

  • National Taiwan University Hospital Clinical Trial Center

    Taipei,
    Taiwan

    Active - Recruiting

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