Health Condition 1: K590- Constipation
Conditions
Interventions
Intervention1: Linaclotide (72 g or 145 g once daily: Linaclotide (72 g or 145 g once daily) administered orally as prescribed by the treating physician in patients with Functional Constipation or
Sponsors
Dept of Gastroenterology Dayanand Medical College and Hospital
Eligibility
Inclusion criteria
Inclusion criteria: Adults aged eighteen to eighty years. Diagnosis of Functional Constipation or Constipation Predominant Irritable Bowel Syndrome according to Rome Four criteria. Patients reporting three or fewer Complete Spontaneous Bowel Movements per week during the previous two weeks. Moderate to severe symptom severity as assessed by the Constipation Severity Instrument. Stable maintenance therapy for chronic medications with stable dosage for at least thirty days before study entry. Willing and able to provide written informed consent. Willing to comply with study procedures, assessments and follow up. Agrees not to make any major lifestyle changes that may affect constipation symptoms during the study period.
Exclusion criteria
Exclusion criteria: Pregnant, breastfeeding or planning pregnancy. Presence of gastrointestinal alarm features including lower gastrointestinal bleeding, iron deficiency anemia, unexplained weight loss, inflammatory bowel disease or systemic infection. Bristol Stool Form Scale score of six or seven in more than twenty five percent of bowel movements in the absence of laxative use. Meets Rome Four criteria for Opioid Induced Constipation. History of structural gastrointestinal abnormalities or diseases affecting gastrointestinal motility. History of diverticulitis, chronic pancreatitis, active peptic ulcer disease, ischemic colitis, inflammatory bowel disease, laxative abuse, fecal impaction requiring hospitalization, pseudo obstruction, megacolon, megarectum, bowel obstruction or descending perineum syndrome. History or family history of familial adenomatous polyposis, hereditary non polyposis colorectal cancer or other familial colorectal cancer syndromes. Neurological disorders associated with constipation including Parkinson disease, spinal cord injury or multiple sclerosis. Pelvic floor dysfunction, intestinal prolapse or rectal prolapse. Diabetic neuropathy. History of abdominal or gynecological surgery. Active or previous malignancy. Human Immunodeficiency Virus infection. History of psychiatric hospitalization or suicide attempt within the previous two years. Alcohol or drug abuse within the previous six months. Serum creatinine one point five times above the upper limit of normal or greater. Aspartate aminotransferase or Alanine aminotransferase three times above the upper limit of normal or greater. Hemoglobin less than eight gram per deciliter. Any clinically significant medical condition or laboratory abnormality that may interfere with study participation as determined by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving a clinically meaningful response defined as at least three Complete Spontaneous Bowel Movements per week for at least seventy five percent of the twelve week treatment period.Timepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in weekly frequency of Complete Spontaneous Bowel Movements from baseline.Timepoint: Week 6 and Week 12;Change in stool consistency assessed using the Bristol Stool Form Scale.Timepoint: Week 6 and Week 12;Time to first Complete Spontaneous Bowel Movement after initiation of Linaclotide treatment.Timepoint: During the 12 week treatment period;Change in patient reported symptoms including straining, sensation of incomplete evacuation, bloating and abdominal discomfort assessed using the Constipation Severity Instrument.Timepoint: Week 6 and Week 12;Change in Patient Assessment of Constipation Quality of Life questionnaire score.Timepoint: Week 12;Proportion of patients requiring rescue medication.Timepoint: During the 12 week treatment period;Proportion of patients experiencing treatment emergent adverse events including abdominal pain, diarrhea, nausea, headache and cardiovascular events.Timepoint: During the 12 week treatment period;Change from baseline in weekly degree of straining during spontaneous bowel movements.Timepoint: Week 6 and Week 12 | — |
Countries
India
Contacts
Public ContactDr Omesh Goyal
Dayanand Medical College and Hospital
Outcome results
None listed