Health Condition 1: K590- Constipation
Conditions
Interventions
Intervention1: Linaclotide Capsule: Linaclotide 72 mcg once daily. If response (average SBM rate =3/week and an
increase of =1 from baseline for 3 of the first 4 weeks of the treatment period) is not
Sponsors
Dr Reddys Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients of 18-65 years age 2. Ambulatory patients with chronic constipation (Fulfilling Rome IV criteria) reporting less than 3 Spontaneous Bowel Movements (SBM) per week and reports one or more of the following symptoms for the last 3 months with symptom onset at least 6 months before the Screening Visit or before starting chronic therapy with any laxative: ? Straining during more than 25% of defecations ? Lumpy or hard stools more than 25% of defecations ? Sensation of incomplete evacuation more than 25% of defecations 3. Patients with less than 3 CSBM per week during pretreatment period. 4. Willing to comply with protocol requirements and sign a statement of informed consent 5. Willing to discontinue any laxatives used before the Pretreatment period in favor of the protocol-defined Rescue Medicine (bisacodyl Capsules or suppositories) 6. Agreed to refrain from making any new, major lifestyle changes that may have affected CIC symptoms (e.g., starting a new diet or changing his or her exercise pattern) from the time of signature of the ICF to the last trial visit. 7. Female subjects of child-bearing potential should have negative serum pregnancy test at screening and agree to use adequate birth control during the entire study period. OR Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the study subject). OR Postmenopausal for at least 1 year
Exclusion criteria
Exclusion criteria: 1. Pregnant, breast feeding, or planning a pregnancy 2. Subject of any age with evidence of clinically significant weight loss, or rectal bleeding and without documentation of the results of either a flexible sigmoidoscopy or colonoscopy performed within 2-years period prior to screening. 3. Reports loose (mushy) or watery stools in the absence of any laxative intake in the form of a Capsule, a suppository or an enema, or prohibited medicine for greater than 25% of bowel movements 4. Reported a Bristol Stool Form Scale score of 6 (loose, mushy stools) for greater than 1 SBM or a Bristol Stool Form Scale score of 7 (watery stools) with any SBM over the 2 weeks pretreatment period before the Randomization Visit [Refer to appendix 3 for BSFS scale]. 5. Received a diagnosis of inflammatory bowel disease (IBD) 6. Meet the Rome IV criteria for Irritable Bowel Syndrome (IBS) or the Rome IV criteria for Opioid-Induced Constipation (OIC). 7. Has a history of structural abnormality of the Gastrointestinal (GI) tract or a disease or condition that can affect GI motility 8. Has a history of diverticulitis, chronic pancreatitis, active peptic ulcer disease (PUD) not adequately treated, ischaemic colitis, inflammatory bowel disease, laxative abuse, faecal impaction that required hospitalization or emergency treatment, pseudo-obstruction, mega colon, mega rectum, bowel obstruction, descending perineum syndrome, ovarian cysts, endometriosis, solitary rectal ulcer syndrome, systemic sclerosis, pre-malignant colonic disease (e.g., familial adenomatous polyposis or hereditary non-polyposis colorectal cancer) or other forms of familial colorectal cancer. 9. Diagnosis or family history of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, or any other form of familial colorectal cancer 10. Current active peptic ulcer disease (i.e., disease that was not adequately treated or stable with therapy) 11. Has unexplained and clinically significant GI alarm signals (e.g., lower GI bleeding or heme-positive stool in the absence of known internal or external haemorrhoids, iron-deficiency anaemia, unexplained weight loss) or systemic signs of infection or colitis. 12. Patients who require chronic diuretic treatment 13. Has clinically significant laboratory findings or medical condition that could potentially affect study participation and/or personal well-being, as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to week 12 of Complete Spontaneous Bowel Movement (CSBM).Timepoint: 12 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change from baseline in 12 week CSBM frequency rate 2. Change in weekly SBM frequency rate from baseline 3. Change in stool consistency score 4. Change in straining score 5. Change in abdominal bloating 6. Change in abdominal discomfortTimepoint: 12 Weeks | — |
Countries
India
Contacts
Public ContactSandip Chakraborty
Dr. Reddy’s Laboratories Limited
Outcome results
None listed