"Efficacy and Safety of Linaclotide in Chronic Constipation"

Официальное название

"Efficacy and Safety of Linaclotide in Chronic Constipation : A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study"

Обзор

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.

Вмешательства

• Препарат Linaclotide 72 micrograms
  Linaclotide 72 micrograms will be given in Group A
• Препарат Linaclotide 145 micrograms
  Linaclotide 145 micrograms will be given in Group B
• Другое Placebo
  Placebo will be given in Group C

Первичные конечные точки

• Complete Spontaneous Bowel Movement (CSBM) responder rate [Срок оценки: 8 weeks]

Вторичные конечные точки (10)

• Mean change in weekly SBM frequency [Срок оценки: 8 weeks]
• Mean change in CSBM frequency [Срок оценки: 8 weeks]
• Changes in weekly stool consistency measured by Bristol Stool Form Scale (BSFS) [Срок оценки: 8 weeks]
• Change in average weekly bloating score [Срок оценки: 8 weeks]
• Change in weekly straining score [Срок оценки: 8 weeks]
• Change in weekly abdominal pain or discomfort score [Срок оценки: 8 weeks]
• Change in satisfaction score related to defecation [Срок оценки: 8 weeks]
• Patient reported adverse events [Срок оценки: Through study completion, an average of 10 weeks]
• Sustainability of treatment effects [Срок оценки: 2 week of drug free follow up period (from week-9 to week-10)]
• Potentially rebound of symptoms [Срок оценки: 2 week of drug free follow up period (from week-9 to week-10)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Bangladesh · 1 центр

• Dhaka Medical College — Dhaka

Идентификаторы

NCT: NCT07431957 · IRB-DMC/2025/261

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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