Functional bowel disorders
Conditions
Interventions
Trade Name: Bisacodyl
Product Name: Bisacodyl
Pharmaceutical Form: Tablet
INN or Proposed INN: Bisacodyl 5mg
CAS Number: 603-50-9
Other descriptive name: BISACODYL
Concentration unit: mg milligram(s)
Sponsors
KU Leuven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient is a man or woman aged 18 to 80 years, inclusive, at prescreening. 2. Patient has a diagnosis of a functional bowel disorder according to the Rome IV criteria. 3. Patient needs a colonoscopy for diagnostic reasons, for risk factors (age above 50 years of age), or because of occurrence of alarm features (weight loss within the past 6 months; family history of colorectal cancer or IBD; blood loss with their stool, not convincingly due to hemorrhoids or fissure). 4. Patient has not used any loperamide rescue medication within 2 days prior to randomization. 5. Patient has not used any opioid medication to reduce their pain within 14 days prior to randomization 6. Patients on stable doses of antidepressants (ie, for the 3 months prior to prescreening) will be allowed to participate in the study. Medications taken for the treatment of allergies, chronic medical conditions, and migraine headaches can be taken during this study (with the exception of opioids for acute treatment of migraines). Patient must be on a stable dose of medication for chronic migraines or preventative therapy for at least 1 month at prescreening. As needed use of benzodiazepines, if habitual, is permitted. 7. Female patients must be: a. postmenopausal, defined as 52 years or older and amenorrheic for at least 2 years at prescreening, b. surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), c. abstinent, or d. if sexually active, be practicing an effective method of birth control such as hormonal prescription oral contraceptives, progesterone implants or injections, contraceptive patch, intrauterine device, or male partner with a vasectomy. 8. Patient must sign an informed consent document before the initiation of any study-related procedures indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 85 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. History of inflammatory or immune-mediated GI disorders including inflammatory bowel disease (ie, Crohn’s disease, ulcerative colitis) and celiac disease. 2. History of diverticulitis 3. History of intestinal obstruction, stricture, toxic megacolon, GI perforation, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation (eg, aortoiliac disease). 4. Patient has any of the following surgical history: a. Any abdominal surgery within the 3 months prior to prescreening; b. Patient has a history of major gastric, hepatic, pancreatic, or intestinal surgery (appendectomy, hemorrhoidectomy, or polypectomy greater than 3 months post-surgery are allowed). 5. History or current evidence of laxative abuse. 6. Patient has a history of a cardiovascular event, including stroke, myocardial infarction, congestive heart failure, or transient ischemic attack within 6 months prior to prescreening. 7. Patient has an unstable renal, hepatic, metabolic, or hematologic condition. 8. Patient has a history of malignancy within 5 years before prescreening (except squamous and basal cell carcinomas and cervical carcinoma in situ). 9. Patient has abnormal thyroid function test as confirmed by thyroid-stimulating hormone <0.3 mcIU/mL or =5 mcIU/mL at Prescreening. However, patients who are clinically euthyroid due to thyroid supplement are candidates for the study. 10. Patient has current (within 14 days of randomization) or expected use of any narcotic or opioid containing agents, docusate, enemas, GI preparations (including antacids containing aluminum or magnesium, antidiarrheal agents, antinausea agents, antispasmodic agents, bismuth, or prokinetic agents). 11. Patient is pregnant or breastfeeding. 12. Patient has any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Clarify whether FBD-type related differences in motor pattern occurrence and aspects (amplitude in mmHg, duration in seconds, simultaneous or propagating, with direction and extent in centimeters, velocity in centimeters /second and colonic site of origin) can explain disease presentation, and give insight in disease pathophysiology.;Secondary Objective: Linking colonic motor patterns to propagation of content using colonic intraluminal impedance monitoring.;Primary end point(s): Evaluation of the motor patterns characteristics and the discrepancy in occurrence of sequences in FBDs versus health and between separate FBDs.;Timepoint(s) of evaluation of this end point: After the single colonic manometry | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Description of the relationship between colonic motor patterns and propulsion. - Description of the relationship between colonic motor patterns and symptoms. ;Timepoint(s) of evaluation of this end point: After the single colonic manometry | — |
Countries
Belgium
Contacts
Public ContactJasper Pannemans; Sub Investigator
KU Leuven
Outcome results
None listed