Health Condition 1: null- Irritable Bowel Syndrome - Constipation
Conditions
Interventions
Intervention1: Linaclotide Capsules 290mcg: Manufactured by Aurobindo Pharma Limited . To be taken orally one capsules per day 30 minutes before first meal of the day
Control Intervention1: Linzess: L
Sponsors
Aurobindo Pharma Limited
AXIS Clinicals Limited
Eligibility
Inclusion criteria
Inclusion criteria: Male or female aged between 18 to 65 years Ability to provide written informed consent Diagnosed case of IBS according to Rome 3 Criteria, who are suffering from constipation 2 days a week during screening evaluation. Irritable Bowel Syndrome Diagnostic criterion - Rome 3 criteria Recurrent abdominal pain or discomfort at least 3 days in a month during the last 3 months associated with two or more of the following: Improvement with defecation Onset associated with a change in frequency of stool Onset associated with a change in form (appearance) of stool Patient has weekly average of worst abdominal pain in past 24 hours score of more than 3 in a 0 to 10 point scale and has less than 3 complete spontaneous bowel movements CSBM per week. Subjects had no clinically significant findings on physical examination, 12-lead ECG, clinical laboratory tests and urine analysis at the discretion of Principal Investigator. Subjects must have negative test results for HIV 1 and 2 HCV and HBsAg. Subjects agreed to use prescribed method of contraception directed by study team Females of childbearing potential must have a negative pregnancy test. Available for the entire study period and willing to adhere to protocol requirements as evidenced by written informed consent.
Exclusion criteria
Exclusion criteria: Patient reported loose mushy or watery stools BSFS-Bristol Stool Form Scale score of 6 or 7 in the absence of any laxative, suppository, enema, or prohibited medicine for more than 25 percent of Bowel Movements during the 12 weeks before the Screening Visit Patient currently had both unexplained and clinically significant alarm symptoms lower GI bleeding rectal bleeding or heme-positive stool , iron-deficiency anemia or any unexplained anemia, or weight loss and systemic signs of infection or colitis Patient had a structural abnormality of the gastrointestinal GI tract or a disease or history of a condition that could affect GI motility. Patient had a history of potential central nervous system cause of constipation example Parkinsonâ??s disease, spinal cord injury, and multiple sclerosis Patient had any of the following diseases or conditions that could be associated with constipation: pseudo-obstruction, colon inertia, megacolon, megarectum, bowel obstruction, descending perineum syndrome, solitary rectal ulcer syndrome, systemic sclerosis Patient had a diagnosis of familial adenomatous polyposis, hereditary non-polyposis colorectal cancer, or any other form of familial colorectal cancer, or inflammatory bowel disease. Patient had a family history of familial adenomatous polyposis or hereditary non-polyposis colorectal cancer or other familial form of colorectal cancer Patient having immune system disorders allergic reactions, urticaria, or hives as adverse events or allergic to Linaclotide Patient having Cholelithiasis or other Gallbladder disorders. Patient have done prior abdominal surgery which may cause bowel symptoms similar to IBS Patients unable to stop anti-muscarinics, anti-spasmodics, high dose tricyclic antidepressants example above 50 mg per day opiates anti-diarrheal drugs, NSAIDs (occasional over the counter use and topical formulations are allowed), long-term antibiotics, other anti-inflammatory drugs or 5-ASA containing drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increase of at least one or more CSBM per week from Baseline At least 30 percent decrease in weekly average of worst abdominal pain in the past 24 hours score in comparison to BaselineTimepoint: Increase of at least one or more CSBM per week from Baseline At least 30 percent decrease in weekly average of worst abdominal pain in the past 24 hours score in comparison to Baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in CSBM frequency rate from Baseline to Week 12. Change in SBM frequency rate from Baseline to Week 12. Change in stool consistency from Baseline to Week 12. Change in severity of straining from Baseline to Week 12 Change in abdominal discomfort from Baseline to Week 12. Change in bloating from Baseline to Week 12. Change in constipation severity from Baseline to Week 12 Change in abdominal pain score from Baseline to Week 12 Timepoint: Nil | — |
Countries
India
Contacts
Public ContactDr Subhra Lahiri
AXIS Clinicals Limited
Outcome results
None listed