Trial · Interventional
Not yet recruitingPhase 4Registry data"Efficacy and Safety of Linaclotide in Chronic Constipation"
Short name LIN-CC-BD
Overview
- Status
- Not yet recruiting
- Phase
- Phase 4
- Enrollment
- 90 participants (estimated)
- Sponsor
- Md Mehedi Shahriar · Other
- Design
- Randomized · Double masking
- Countries
1 country
Bangladesh
- Start
- 20 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Completion
- 31 Jan 2027 (estimated)
- First posted
- 25 Feb 2026
- Last update posted
- 25 Feb 2026
- Conditions
- Chronic Idiopathic Constipation · Irritable Bowel Syndrome (IBS-C) · Chronic Constipation · CIC · Constipation Predominant Irritable Bowel Syndrome
Timeline
1 trial · 1 not yet recruiting
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 4
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Goal of this study is to evaluate the efficacy and safety of two different doses of Linaclotide in improving bowel function and patient-reported outcomes among Bangladeshi patients with chronic constipation for 8 weeks along with an additional short drug-free follow up period of 2 weeks. The main question it aims to answer is "Does Linaclotide at doses of 72microgram or 145microgram once daily improve bowel function and patient-reported coutcomes compared with placebo in Bangladeshi patients with chronic constipation over an 8-week treatment period?" Study procedure: From outpatient department of Gastroenterology, Dhaka Medical College, a total of 90 adult patients diagnosed with chronic idiopathic constipation (CIC) or constipation predominant irritable bowel syndrome (IBS-C) by ROME-IV criteria will be selected after baseline evaluation including clinical history, physical examination, laboratory tests and colonoscopy. Before enrollment eligible participants will undergo 1-week baseline stool diary which will include baseline data of patient reported severity of abdominal symptoms (bowel movement, stool frequency, bloating, abdominal pain or discomfort and defecatory satisfaction score). Patients reporting more than 3 SBMs during baseline run in period will be excluded from the study. Finally total 90 patients will be enrolled as participants who will be randomly assigned to one of the three groups, Group A (Linaclotide 72mcg once daily), Group B (Linaclotide 145mcg once daily) and Group C (Placebo once daily ). The treatment period will start from randomization visit (day 0) and will be continued for 8 weeks. All participants will receive identical looking drugs (72mcg or 145mcg or placebo) 30 minutes before breakfast and they will be requested to maintain standard dietary and lifestyle advices including increased intake of high fiber diet and fluid throughout the study. Patients will record spontaneous bowel movement (SBM) and complete spontaneous bowel movement (CSBM), stool consistency using Bristol Stool Form Scale (BSFS), severity of abdominal symptoms by 5-point Likert scale, use of rescue medication after 3 days of absolute constipation and adverse events such as diarrhea in their daily stool diary. They will be followed up at week-4, week-8 and after 2-week drug free withdrawal period at week-10 with review of stool diary and safety assessments. Entire study will be monitored by Data Safety Monitoring Board (DSMB) of Dhaka Medical College.
Interventions
- Linaclotide 72 microgramsDrug
- Linaclotide 145 microgramsDrug
- PlaceboOther
Arms3
Experimental
Linaclotide 72
Group A - Linaclotide 72 mcg
Experimental
Linaclotide 145
Group B - Linaclotide 145 mcg
Placebo comparator
Placebo
Group C - Placebo
Primary outcomes1
Outcomes the sponsor listed as primary.
Complete Spontaneous Bowel Movement (CSBM) responder rate
Time frame · 8 weeks
Registry description
Complete Spontaneous Bowel Movement (CSBM) responder rate is defined as the proportion of patients achieving 3 or more complete spontaneous bowel movements (CSBM) per week with an increase of 1 or more CSBM per week from baseline for at least 6 of the treatment weeks. Patient will be maintaining a daily stool diary from which data will be obtained and CSBM responder rate will be assessed.
Secondary outcomes(10)
Mean change in weekly SBM frequency
Time frame · 8 weeks
Registry description
Mean change in weekly Spontaneous Bowel Movement (SBM) after 8 weeks from baseline.
Mean change in CSBM frequency
Time frame · 8 weeks
Registry description
Mean change in weekly Complete Spontaneous Bowel Movement (CSBM) after 8 weeks from baseline
Changes in weekly stool consistency measured by Bristol Stool Form Scale (BSFS)
Time frame · 8 weeks
Registry description
Change in weekly stool consistency from baseline using Bristol Stool Form Scale (BSFS). The scale consists of various stool forms from type 1 to type 7. (Type 1- separate hard lumps, like nuts and hard to pass, Type 2-sausage shaped but lumpy, Type 3- Like a sausage but with cracks on the surface, Type 4- Like a sausage or snake, smooth and soft, Type 5- soft blobs with clear cut edges, Type 6- fluffy pieces ragged edges, a mushy stool, Type 7- watery, no solid pieces, entirely liquid).
Change in average weekly bloating score
Time frame · 8 weeks
Registry description
Change in average weekly bloating score from baseline to week-8 using a 5-point Likert scale . Bloating means subjective abdominal fullness or distension reported by the patient. Bloating score is evaluated on a 5-point Likert scale (From 1 to 5, higher score means worse outcome)
Change in weekly straining score
Time frame · 8 weeks
Registry description
Change in weekly straining score from baseline to week-8 will be measured using 5-point Likert scale (from 1 to 5, higher score means worse outcome)
Change in weekly abdominal pain or discomfort score
Time frame · 8 weeks
Registry description
Change in weekly abdominal pain or discomfort score from baseline to week-8 will be measured using 5-point Likert scale (from 1 to 5, higher score means worse outcome)
Change in satisfaction score related to defecation
Time frame · 8 weeks
Registry description
Satisfaction score related to defecation will be measured using 5-point defecatory satisfaction score (Likert scale, from 1 to 5, lower score means worse outcome) and change will be compared between baseline value and week-8 value.
Patient reported adverse events
Time frame · Through study completion, an average of 10 weeks
Registry description
Patient-reported adverse events associated with Linaclotide treatment will be documented according to common terminology criteria for adverse events (CTCAE grading).
Sustainability of treatment effects
Time frame · 2 week of drug free follow up period (from week-9 to week-10)
Registry description
Sustainability of treatment effects: Sustainability will be defined as maintenance of improved symptom scores during the 2 week drug free follow up period after week-8 at levels that are not statistically significantly worse than end of treatment values and remain no worse than baseline. These symptom scores includes weekly spontaneous bowel movement (SBM) and complete spontaneous bowel movement (CSBM) frequency, stool consistency measured by Bristol Stool Form scale (BSFS, from type 1 to 7), abdominal symptom scores including bloating score, straining score, abdominal pain or discomfort scores using 5-point Likert scale (1 to 5, higher score means worse outcome), satisfaction score related to defecation using 5-point Likert scale (1 to 5, Lower score means worse outcome) etc.
Potentially rebound of symptoms
Time frame · 2 week of drug free follow up period (from week-9 to week-10)
Registry description
Rebound of symptoms: Rebound will be defined as worsening of symptom measures beyond baseline levels during the drug free follow up period. These symptom scores includes weekly spontaneous bowel movement (SBM) and complete spontaneous bowel movement (CSBM) frequency, stool consistency measured by Bristol Stool Form scale (BSFS, from type 1 to 7), abdominal symptom scores including bloating score, straining score, abdominal pain or discomfort scores using 5-point Likert scale (1 to 5, higher score means worse outcome), satisfaction score related to defecation using 5-point Likert scale (1 to 5, Lower score means worse outcome) etc.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
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Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 70 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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