Health Condition 1: null- Adult Patients with Chronic Functional Constipation Health Condition 2: K590- Constipation
Conditions
Interventions
Intervention1: Prucalopride 2 mg tablets: Prucalopride 2 mg tablets manufactured by Hetero (or) Prucalopride 2 mg matching Placebo tablets manufactured by Hetero, orally once daily
Control Interventio
Sponsors
Hetero Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult male and female outpatients aged 18-65 years and willing to give written, signed, and dated informed consent to participate in the study before initiating any study related procedures 2. History of functional constipation, not satisfied with laxatives: Functional Constipation as defined by Rome III Diagnostic Criteria. i. Must include two or more of the following: a. Straining during at least 25% of defecations b. Lumpy or hard stools in at least 25% of defecations c. Sensation of incomplete evacuation for at least 25% of defecations d. Sensation of anorectal obstruction/blockage for at least 25% of defecations e. Manual maneuvers to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor) f. Fewer than three defecations per week ii. Loose stools are rarely present without the use of laxatives iii. Insufficient criteria for irritable bowel syndrome These criteria must be fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis. 3. Patients with normal ECG including QTc at baseline 4. Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from screening throughout the duration of the study
Exclusion criteria
Exclusion criteria: 1. Constipation secondary to other diseases/conditions (surgery, endocrine disorders, metabolic disorders or neurologic disorders or drug induced or suspected organic disorders of the large bowel, i.e., obstruction, carcinoma, or inflammatory bowel disease) 2. Patients who have polyps discovered on colonoscopy that are untreated (i.e., by polypectomy) 3. Use of or intent to use disallowed medications that influence the bowel habit during the study (i.e., anticholinergics (not including antihistamines), opioids, spasmolytics, prokinetics, and tricyclic antidepressants 4. Patients with the use of medication contain lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption 5. Have severe and clinically uncontrolled cardiovascular, liver, orlung disease, neurologic or psychiatric disorders (including active alcohol or drug abuse), cancer or acquired immune deficiency syndrome (AIDS), or other gastrointestinal or endocrine disorders 6. Patients with history of anaemia with haemoglobin less than 12.5 gm/dL for male and less than 12 gm/dL for female 7. Patients with impaired renal function, i.e., serum creatinine >2 mg/dL ( >180 mmol/L) 8. Patients with clinically significant abnormalities of hematology, urinalysis, or blood chemistry 9. Known allergies, hypersensitivity, or intolerance to prucalopride or its excipients. 10. Patients on concomitant medications known to prolong QT interval. 11. Any other disease state which could interfere with trial participation or trial evaluation as per investigatorâ??s discretion. 12. Participation in any other clinical trial involving investigational products within 30 days of screening. 13. Women of child-bearing potential, pregnant or lactating women, women practicing contraception by other than barrier methods or intending to donate eggs within the projected duration of the study and post-study follow-up period. 14. Patients unwilling to give informed consent. 15. The physician is of the opinion that changing a patientâ??s trial medications would put the patient at risk.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of patients with weekly average of 3 or more spontaneous, complete bowel movements (SCBM)Timepoint: 12 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of treatment compliance during the treatment periodTimepoint: All visits;Average number of SCBMs per weekTimepoint: 12 Weeks;Clinical Global Impression of Change (CGIC) and Patient Global Impression of Change (PGIC) will be assessed at the EOTTimepoint: End of Treatment;Patient Assessment of Constipation Quality of Life (PAC-QOL) self-report questionnaire at baseline and at week 12Timepoint: baseline and at week 12;Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire at baseline and at weeks 4, 8 and 12Timepoint: Baseline and at weeks 4, 8 and 12;The average number of bisacodyl tablets or enemas used per weekTimepoint: 12 Weeks;The patients global assessment of efficacy of treatment at baseline and at weeks 2, 4, 8, and 12 with the use of a 5-point Likert scale, ranging from "not at all effective" (0) to "extremely effective" (4)Timepoint: At weeks 2, 4, 8, and 12;The percentage of patients with a weekly average of 3 or more SCBMs during the first 8 weeks of the treatment periodTimepoint: 8 Weeks;The percentage of patients with change of 1 SCBM/weekTimepoint: 12 Weeks;Time to first SBMTimepoint: 12 Weeks;Treatment emergent clinical & laboratory adverse events (TEAEs) - adverse events, laboratory parameters, vital signs, and electrocardiogram (ECG) data in 12 weeksTimepoint: 12 Weeks | — |
Countries
India
Contacts
Public ContactDr Shubhadeep Sinha MD
Hetero Drugs Limited
Outcome results
None listed