A Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Goofice® in Patients With Chronic Constipation
Overview
- Phase
- Phase 3
- Intervention
- Goofice®
- Conditions
- Constipation
- Sponsor
- Synmosa Biopharma Corp.
- Enrollment
- 351
- Locations
- 1
- Primary Endpoint
- Overall Complete spontaneous bowel movement(CSBM) responder rate during 12 weeks treatment
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
This is a double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of Goofice® in patients with chronic constipation.
Detailed 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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:
Exclusion Criteria
- •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.
Arms & Interventions
Goofice®
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).
Intervention: Goofice®
Goofice® Placebo
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
Intervention: Goofice® Placebo
Outcomes
Primary Outcomes
Overall Complete spontaneous bowel movement(CSBM) responder rate during 12 weeks treatment
Time Frame: 12 weeks
* 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.
Secondary Outcomes
- Efficacy endpoint - SBM frequency(12 weeks)
- Efficacy endpoint - CSBM frequency(12 weeks)
- 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)
- Exploratory endpoint - Patient Assessment of Constipation Quality of Life (PAC-QoL)(12 weeks)
- Efficacy endpoint - SBM and CSBM responder rate(4 weeks)
- Efficacy endpoint - Mean stool consistency by Bristol Stool Form Scale(12 weeks)
- Exploratory endpoint - Patient Assessment of Constipation Symptoms (PAC-SYM) scores(12 weeks)