A Study to Assess Efficacy of bamk-001 in Patients with Conspitatio
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0003521
- Lead Sponsor
- BMS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 41
1) Aged 20 - 79 years
2) Reported symptoms associated with constipation for at least 6 months before enrollment, and diagnosed with functional constipation according to Rome IV criteria, which state that two or more of the following symptoms must have been noted in the 3 months previous to enrollment at least 25% of bowel movements:
? straining,
? lumpy or hard stool,
? sense of incomplete evacuation,
? anorectal blockage,
? manual maneuvers to facilitate defecation,
? less than three bowel movements per week
3) BMI greater than 18 kg/m2 and less than 40 kg/m2
4) Agree to follow the instruction and sign up with Informed Consent Form
1) reported any diseases by colonoscopy or radiologic examination
2) presence of other diseases that can cause secondary constipation (e.g. neurological disorders such as Parkinson’s disease or severe myelopathy, multiple sclerosis, hypothyroidism, diabetes mellitus) or other severe illness
3) history of laparotomy or peritonitis
4) history of GI disease or abdominal surgery except appendicectomy and Inguinal herniorrhaphy
5) diagnosed with irritable bowel syndrome (IBS) according to Rome IV criteria
6) Patient who have clinically significant disease or history of hepatobiliary disorders, Renal and urinary disorders, nervous system disorders, respiratory disorders, blood and lymphatic system disorders, endocrine disorders, cardiac disorders and psychiatric disorders.
7) Pregnant or breastfeeding
8) Patient who disagree with contraception
9) Patient who will not suitable for the study judged by investigator
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Colon Transit Time;Adverse events/Serious adverse events
- Secondary Outcome Measures
Name Time Method Questionaire(Number of spontaneous bowel movements per week, Bowel movement with straining, Stool form, Feeling of incomplete emptying, Feeling of anorectal blockage, Abdominal discomfort and pain, Overall defecation satisfaction)