Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-04-06 @ 1:44 AM
Study NCT ID:
NCT07431957
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-25
First Post:
2026-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
"Efficacy and Safety of Linaclotide in Chronic Constipation"
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Phase IV investigator initiated trial with off-label dose evaluation'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-21', 'studyFirstSubmitDate': '2026-02-10', 'studyFirstSubmitQcDate': '2026-02-21', 'lastUpdatePostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete Spontaneous Bowel Movement (CSBM) responder rate', 'timeFrame': '8 weeks', '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.'}], 'secondaryOutcomes': [{'measure': 'Mean change in weekly SBM frequency', 'timeFrame': '8 weeks', 'description': 'Mean change in weekly Spontaneous Bowel Movement (SBM) after 8 weeks from baseline.'}, {'measure': 'Mean change in CSBM frequency', 'timeFrame': '8 weeks', 'description': 'Mean change in weekly Complete Spontaneous Bowel Movement (CSBM) after 8 weeks from baseline'}, {'measure': 'Changes in weekly stool consistency measured by Bristol Stool Form Scale (BSFS)', 'timeFrame': '8 weeks', '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).'}, {'measure': 'Change in average weekly bloating score', 'timeFrame': '8 weeks', 'description': 'Change in average weekly bloating score from baseline to week-8 using a 5-point Likert scale .\n\nBloating means subjective abdominal fullness or distension reported by the patient.\n\nBloating score is evaluated on a 5-point Likert scale (From 1 to 5, higher score means worse outcome)'}, {'measure': 'Change in weekly straining score', 'timeFrame': '8 weeks', '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)'}, {'measure': 'Change in weekly abdominal pain or discomfort score', 'timeFrame': '8 weeks', '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)'}, {'measure': 'Change in satisfaction score related to defecation', 'timeFrame': '8 weeks', '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.'}, {'measure': 'Patient reported adverse events', 'timeFrame': 'Through study completion, an average of 10 weeks', 'description': 'Patient-reported adverse events associated with Linaclotide treatment will be documented according to common terminology criteria for adverse events (CTCAE grading).'}, {'measure': 'Sustainability of treatment effects', 'timeFrame': '2 week of drug free follow up period (from week-9 to week-10)', 'description': 'Sustainability of treatment effects:\n\nSustainability 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.\n\nThese 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.'}, {'measure': 'Potentially rebound of symptoms', 'timeFrame': '2 week of drug free follow up period (from week-9 to week-10)', 'description': 'Rebound of symptoms:\n\nRebound will be defined as worsening of symptom measures beyond baseline levels during the drug free follow up period.\n\nThese 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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'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)'], 'conditions': ['Chronic Idiopathic Constipation', 'Irritable Bowel Syndrome (IBS-C)', 'Chronic Constipation', 'CIC', 'Constipation Predominant Irritable Bowel Syndrome']}, 'descriptionModule': {'briefSummary': '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?"\n\nStudy procedure:\n\nFrom 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult patients (18-70 years)\n* patients diagnosed with CIC or IBS-C based on Rome IV criteria\n* No abnormal finding on colonoscopy conducted within past 1 year\n* Patients who can read and are willing to complete daily bowel diary and follow study procedures\n\nExclusion Criteria:\n\n* Clinical features suggestive of organic disease ( Anaemia, unexplained weight loss, per rectal bleeding, family history of malignancy)\n* Secondary constipation due to structural, metabolic, or neurological causes (IBD, Colorectal cancer, hypothyroidism, hypercalcemia, DM, Parkinson's disease)\n* History of or new onset intestinal obstruction\n* Prior history of stomach, small intestine and colorectal surgery ( except appendectomy or hemorroidectomy)\n* 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)\n* Use of medication affecting bowel motility ( Lubiprostone, Elobixibat, PEG or prosecretory agents) within 2 week before enrollment\n* Serious cardiovascular, respiratory, renal, GI, hepatic, hematological, neurological or psychiatric illness\n* Pregnancy or lactation"}, 'identificationModule': {'nctId': 'NCT07431957', 'acronym': 'LIN-CC-BD', 'briefTitle': '"Efficacy and Safety of Linaclotide in Chronic Constipation"', 'organization': {'class': 'OTHER', 'fullName': 'Dhaka Medical College'}, 'officialTitle': '"Efficacy and Safety of Linaclotide in Chronic Constipation : A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study"', 'orgStudyIdInfo': {'id': 'IRB-DMC/2025/261'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Linaclotide 72', 'description': 'Group A - Linaclotide 72 mcg', 'interventionNames': ['Drug: Linaclotide 72 micrograms']}, {'type': 'EXPERIMENTAL', 'label': 'Linaclotide 145', 'description': 'Group B - Linaclotide 145 mcg', 'interventionNames': ['Drug: Linaclotide 145 micrograms']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Group C - Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Linaclotide 72 micrograms', 'type': 'DRUG', 'description': 'Linaclotide 72 micrograms will be given in Group A', 'armGroupLabels': ['Linaclotide 72']}, {'name': 'Linaclotide 145 micrograms', 'type': 'DRUG', 'description': 'Linaclotide 145 micrograms will be given in Group B', 'armGroupLabels': ['Linaclotide 145']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo will be given in Group C', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dhaka', 'country': 'Bangladesh', 'contacts': [{'name': 'Md Mehedi Shahriar', 'role': 'CONTACT', 'email': 'msreehan85@gmail.com', 'phone': '+8801753085062'}], 'facility': 'Dhaka Medical College', 'geoPoint': {'lat': 23.7104, 'lon': 90.40744}}], 'centralContacts': [{'name': 'Dr. Md Mehedi Shahriar, MBBS', 'role': 'CONTACT', 'email': 'msreehan85@gmail.com', 'phone': '+8801753085062'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Md Mehedi Shahriar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Md Mehedi Shahriar', 'investigatorAffiliation': 'Dhaka Medical College'}}}}