Health Condition 1: K590- Constipation
Conditions
Interventions
Intervention1: Linaclotide 145 mcg capsules: 145 mg To be taken orally 30 minutes before the first meal of the day, Once a day Manufactured by: Arab Pharmaceutical Manufacturing PSC, Jordan for Hikma
Sponsors
Hikma Pharmaceuticals LLC
Veeda Clinical Research Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Brief inclusion as below, 1. Male or female more than and equal to 18 years with a clinical diagnosis of chronic idiopathic constipation (CIC). 2. Ability to provide written informed consent for the study. 3. Have 1 or more of the following symptoms related to bowel movements: • Lumpy or hard stools for more than 25% of the bowel movements • Sensation of incomplete evacuation following more than 25% of the bowel movements. • Straining at defecation more than 25% of the time. 4. Meet the colonoscopy requirements defined by the American Gastroenterological Association (AGA) guidelines. 5. Willing to discontinue any laxatives used before the Pretreatment Visit in favor of the protocol-defined Rescue Medicine. 6. Agree to refrain from making any new major lifestyle changes that may have affected CIC symptoms from the time of screening to the last trial visit. 7. Free from any clinically significant disease. 8. Comply with protocol & Investigator visit requirements.
Exclusion criteria
Exclusion criteria: 1. Pregnant, breastfeeding, or planning a pregnancy. 2. Subject with evidence of weight loss, anemia, or rectal bleeding or documented colonoscopy performed during the 6 months prior to dosing. 3. Documented mechanical bowel obstruction, megacolon/megarectum, or diagnosis of pseudo-obstruction. 4. GI track Structural abnormality or a disease or condition that could affect GI motility 5. Fecal impaction that required hospitalization or emergency room treatment, or had a history of cathartic colon, laxative or enema abuse, ischemic colitis, or pelvic floor dysfunction. 6. Meet the Rome IV criteria for Irritable Bowel Syndrome or Opioid-Induced Constipation. 7. Diagnosis or family history of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, or any other form of familial colorectal cancer. 8. Current active peptic ulcer disease 9. History of diabetic neuropathy, diverticulitis or any chronic condition that could be associated with abdominal pain or discomfort 10. History of Bariatric surgery or surgery to remove a segment of the GI tract 6 months before the Screening Visit, major surgery within 4 weeks prior to study, an appendectomy or cholecystectomy during the 60 days before the Screening Visit, or other major surgery during the 30 days before the Screening Visit. 11. Potential central nervous system cause of constipation 12. Untreated hypothyroidism or treated hypothyroidism for which the dose of thyroid hormone had not been stable for at least 6 weeks at the time of the Screening Visit 13. Hospitalized for any gastrointestinal or abdominal surgical procedure during the 3 months prior to dosing. 14. Clinically significant cardiovascular, liver, lung, neurologic, renal or psychiatric disorder, or hematologic and/or biochemical abnormalities based on laboratory testing. 15. Used Rescue Medicine or any other laxative, suppository, or enema, on the calendar day before or the calendar day of the start of the Treatment Period. 16. Reported using a Prohibited Medicine during the Pretreatment Period or was not willing or able to abide by the restrictions regarding use of Prohibited Medicines 17. Any other conditions, including severe illness, which would make the patient, in the opinion of the Investigator, unsuitable for the study. 18. Patient had major surgery within 4 weeks prior to study entry, or who have not recovered from prior major surgery. 19. Positive for drugs of abuse or Breath alcohol analyzer test prior to receiving the first dose/baseline of the investigational medicinal product in the study. 20. Patients found positive for HIV, Syphilis, Hepatitis B surface antigen or Hepatitis C antibody at screening. 21. Receipt of an investigational medicinal product or participation in another drug research study within 30 Days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Primary Objective: To evaluate bioequivalence by establishing equivalence between Linaclotide 145 mcg capsule (Hikma Pharmaceuticals LLC, Jordan) to LINZESS® (linaclotide) 145 mcg capsules (Allergan USA) in the treatment of chronic idiopathic constipation. •Primary Endpoint: Number of spontaneous bowel movement (SBM) during Week 1 (study Days 1-7), compared to baseline. Note: An SBM is defined as any bowel movement that did not occur within 24 hours after rescue medication use. Timepoint: Primary endpoint and secondary end point assessment will be done at Visit 4 (Day 4) and Visit 5 (1 weeks) for each study patient deemed eligible for evaluation | — |
Secondary
| Measure | Time frame |
|---|---|
| • Secondary Objective :To assess the safety and tolerability profile of the reference product & test product. To demonstrate statistical superiority of both the Test and Reference products over Placebo in terms of clinical endpoint efficacy. • secondary endpoints - No statistical calculations will be performed . The proportion of patients with a SBM within 24 hours of receiving the first dose [ 24 hours after the first dose] Time to first SBM after the first dose up to 1 week. Change from baseline in 1-Week SBM frequency rate (SBMs/week) Change from Baseline in 1-Week Stool Consistency Assessment (seven-point ordinal Bristol Stool Form Scale) Timepoint: Secondary end point assessment will be done at Visit 4 (Day 4) and Visit 5 (1 weeks) for each study patient deemed eligible for evaluation | — |
Countries
India
Contacts
Public ContactDr Ravi Alamchandani
Veeda Clinical Research Ltd
Outcome results
None listed