Effectiveness and Safety of Suns Lubiprostone capscule in treatment of Chronic Idiopathic Constipatio

Phase 3

Conditions: Health Condition 1: null- Chronic Idiopathic ConstipationHealth Condition 2: K59- Other functional intestinal disorders

Registration Number: CTRI/2015/11/006358

Lead Sponsor: Sun Pharmaceutical Industries Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 1425

Inclusion Criteria

1.Males and non pregnant females aged >= 18 years

2.Subjects with a clinical diagnosis of chronic idiopathic constipation defined as, on average, < 3 spontaneous bowel movements (SBMs) per week and confirmed by daily diary during the 2-week baseline/washout period. An SBM is defined as any bowel movement that did not occur within 24 hours after rescue medication use.

3.Have 1 or more of the following symptoms related to bowel movements for at least 6 months before the baseline visit and confirmed by daily diary during the 2-week baseline/washout period:

•very hard (little balls) and/or hard stools for at least 25% of the bowel movements

•sensation of incomplete evacuation following at least 25% of the bowel movements

•straining at defecation at least a quarter of the time

4.Women of child bearing potential practising an acceptable method of birth control as judged by the investigator(s) [such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), oral or long acting injectable contraceptives] from at least 3 months prior to study entry and through the duration of the study; or postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject); with a negative urine pregnancy test.

5.For subjects aged < 50 years, documentation of the results of either a flexible sigmoidoscopy or colonoscopy performed within the 5 years prior to dosing, showing no mechanical bowel obstruction or organic disorders of the large or small bowel.

6.For subjects aged >= 50 years, documentation of the results of either a barium enema with flexible sigmoidoscopy or colonoscopy performed within 1 year prior to dosing, showing no mechanical bowel obstruction or organic disorders of the large or small bowel.

7.Subjects willing not to significantly alter their lifestyle, exercise regimen or diet during the course of the study.

8.Subjects able and willing to give written informed consent.

9.Subjects able to comply with the requirements of the protocol.

Exclusion Criteria

1.Females who are pregnant, breast feeding, planning a pregnancy, or females of childbearing potential unwilling to use adequate contraception during the course of the study.

2.Subject of any age with evidence of weight loss, anemia, or rectal bleeding AND without documentation of the results of either a flexible sigmoidoscopy or colonoscopy performed during the 6 months prior to dosing.

3.Documented mechanical bowel obstruction (e.g., bowel obstruction due to tumor, hernia), megacolon/ megarectum, or diagnosis of pseudo-obstruction.

4.Known or suspected organic disorders of the large or small bowel (e.g., inflammatory bowel disease, ulcerative colitis, Crohnâ??s Disease) or constipation secondary to a documented cause (e.g., surgery, bowel resection).

5.History of bowel resection.

6.Hospitalized for any gastrointestinal or abdominal surgical procedure during the 3 months prior to dosing.

7.Clinically significant cardiovascular, liver, lung, neurologic, renal or psychiatric disorder, or clinically significant laboratory abnormalities.

8.Subjects with clinically significant cancer within the last 5 years

9.Subjects with history of any medical/ surgical condition that might significantly interfere with the absorption, distribution, metabolism, or excretion of the study drug.

10.Use within 4 weeks prior to baseline of systemic antibiotic.

11.Use of any prescription and/ or OTC laxatives during the 48 hour period prior to the first dose of study medication.

12.Subjects with a history of hypersensitivity to the study drugs (lubiprostone) or to any of the components (as listed in Section 2.1).

13.Known alcohol or drug abuse, heavy smoking (more than 20 cigarettes a day).

14.Subjects who have participated in any other trial involving other investigational products within the last 30 days prior to the first planned drug administration.