This is a double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of Goofice® in patients with chronic constipation.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
351
Once daily before breakfast.
Once daily before breakfast.
National Taiwan University Hospital Clinical Trial Center
Taipei, Taiwan
RECRUITINGOverall 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.
Time frame: 12 weeks
Efficacy endpoint - Complete spontaneous bowel movement (CSBM) responder rate at Week 12
\- A responder will be defined as a subject with weekly (Week 12) CSBM frequency of ≥ 3 times and weekly (Week 12) CSBM frequency improved by ≥ 1 time from Week -1 of the screening period.
Time frame: 12 weeks
Efficacy endpoint - Spontaneous bowel movement (SBM) responder rate at Week 12
\- A responder will be defined as a subject with weekly (Week 12) SBM frequency of ≥3 times and weekly (Week 12) SBM frequency improved by ≥ 1 time from Week -1 of the screening period.
Time frame: 12 weeks
Efficacy endpoint - SBM and CSBM responder rate
\- Changes of SBM and CSBM responder rate during follow-up period.
Time frame: 4 weeks
Efficacy endpoint - SBM frequency
\- Changes in SBM frequency from screening period Week -1 at each week.
Time frame: 12 weeks
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Efficacy endpoint - CSBM frequency
\- Changes in CSBM frequency from screening period Week -1 at each week.
Time frame: 12 weeks
Efficacy endpoint - Mean stool consistency by Bristol Stool Form Scale
\- The stool consistency is assessed based on the Bristol Stool Form Scale on a 7-grade scale. Grade / Interpretation 1. / Separate hard lumps, like nuts (hard to pass) 2. / Sausage shaped, but lumpy 3. / Like a sausage, but with cracks on its surface 4. / Like a sausage or snake, smooth and soft 5. / Soft blobs with clear cut edges (passed easily) 6. / Fluffy pieces with ragged edges, a mushy stool 7. / Watery, no solid pieces, entirely liquid Mean stool consistency as measured at Week -1 and each treatment Week.
Time frame: 12 weeks
Exploratory endpoint - Patient Assessment of Constipation Quality of Life (PAC-QoL)
\- Each item of the 28-item questionnaire (Appendix 1) is scored on a 5-point Likert-type scale from 0 to 4, with (0 = none/not at all, 1 = a little bit/a little bit of the time, 2 = moderately/some of the time, 3 = quite a bit/most of the time, 4 = extremely/all the time). Scores are reported overall and for each of the four subscales (physical discomfort, psychosocial discomfort, worries and concerns, and satisfaction). An improvement (reduction) of ≥1 point in PAC-QoL score are considered clinically significant based on previous validation studies.
Time frame: 12 weeks
Exploratory endpoint - Patient Assessment of Constipation Symptoms (PAC-SYM) scores
\- Symptom scores are evaluated using the PAC-SYM questionnaire, a validated, 12-item, Patient-reported outcome (PRO) instrument with abdominal, stool and rectal symptom subscales. Each item of the PAC-SYM is scored on a 5-point Likert-type scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe), with higher scores indicating greater symptom severity. An improvement (reduction) of ≥1 point in PAC-SYM score is considered clinically significant based on previous validation studies.
Time frame: 12 weeks