"Efficacy and Safety of Linaclotide in Chronic Constipation"

NCT07431957 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: IRB-DMC/2025/261
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Irritable Bowel Syndrome (IBS-C); Chronic Constipation; Constipation Predominant Irritable Bowel Syndrome; Chronic Idiopathic Constipation; CIC

Keywords

CC; CIC; IBS-C; Chronic Constipation (CC); Chronic Idiopathic Constipation (CIC); Constipation predominant Irritable Bowel Syndrome (IBS-C); Linaclotide; LIN-CC-BD; Linaclotide RCT; Irritable Bowel Syndrome (IBS-C)

Outcome Measures

Primary Outcomes (1)

• Complete Spontaneous Bowel Movement (CSBM) responder rate

  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.

  8 weeks

Secondary Outcomes (10)

• Mean change in weekly SBM frequency

  8 weeks

• Mean change in CSBM frequency

  8 weeks

• Changes in weekly stool consistency measured by Bristol Stool Form Scale (BSFS)

  8 weeks

• Change in average weekly bloating score

  8 weeks

• Change in weekly straining score

  8 weeks

Study Arms (3)

Linaclotide 72

EXPERIMENTAL

Group A - Linaclotide 72 mcg

Drug: Linaclotide 72 micrograms

Linaclotide 145

EXPERIMENTAL

Group B - Linaclotide 145 mcg

Drug: Linaclotide 145 micrograms

Placebo

PLACEBO COMPARATOR

Group C - Placebo

Other: Placebo

Interventions

Linaclotide 72 micrograms DRUG

Linaclotide 72 micrograms will be given in Group A

Linaclotide 72

Linaclotide 145 micrograms DRUG

Linaclotide 145 micrograms will be given in Group B

Linaclotide 145

Placebo OTHER

Placebo will be given in Group C

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (18-70 years)
• patients diagnosed with CIC or IBS-C based on Rome IV criteria
• No abnormal finding on colonoscopy conducted within past 1 year
• Patients who can read and are willing to complete daily bowel diary and follow study procedures

You may not qualify if:

• Clinical features suggestive of organic disease ( Anaemia, unexplained weight loss, per rectal bleeding, family history of malignancy)
• Secondary constipation due to structural, metabolic, or neurological causes (IBD, Colorectal cancer, hypothyroidism, hypercalcemia, DM, Parkinson's disease)
• History of or new onset intestinal obstruction
• Prior history of stomach, small intestine and colorectal surgery ( except appendectomy or hemorroidectomy)
• Patients currently suffering from medication induced costipation ( opioids, anti choline raids, calcium channel blockers, oral iron and calcium supplements, anti-Parkinsonian drug, antipsychotic, anti-emetics or psychostimulant drugs)
• Use of medication affecting bowel motility ( Lubiprostone, Elobixibat, PEG or prosecretory agents) within 2 week before enrollment
• Serious cardiovascular, respiratory, renal, GI, hepatic, hematological, neurological or psychiatric illness
• Pregnancy or lactation

Sponsors & Collaborators

• Md Mehedi Shahriar: lead

Study Sites (1)

Dhaka Medical College

Dhaka, Bangladesh

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Dr. Md Mehedi Shahriar, MBBS

CONTACT

+8801753085062; msreehan85@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: Phase IV investigator initiated trial with off-label dose evaluation

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 25, 2026
• Study Start: February 20, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)