A clinical study to evaluate efficacy and tolerability of Prucalopride in Indian adult patients with Chronic Functional Constipatio
- Conditions
- Health Condition 1: null- Adult Patients with Chronic Functional ConstipationHealth Condition 2: K590- Constipation
- Registration Number
- CTRI/2016/11/007461
- Lead Sponsor
- Hetero Labs Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 208
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method