K599 Functional intestinal disorder, unspecified Functional intestinal disorder, unspecified
Conditions
Sponsors
LABORATORIOS FARMACEUTICOS MARKOS S.A
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants of both sexes between 18 to 60 years of age 2. Have a diagnosis of functional chronic constipation, according to their medical history as defined by the Rome IV diagnostic criteria. Criteria met during the last 3 months with onset of symptoms at least 6 months before diagnosis. a) Presence of two or more of the following criteria: • Excessive straining in at least 25% of stools • Hard stools in at least 25% of stools (Bristol type 1-2) • Feeling of incomplete evacuation in at least 25% of stools • Anorectal blockage or blockage sensation in at least 25% of bowel movements • Manual maneuvers to facilitate defecation in at least 25% of bowel movements • Less than three complete spontaneous bowel movements a week b) The presence of liquid stools is rare without the use of laxatives c) There should not be sufficient criteria for the diagnosis of Irritable Bowel Syndrome 3. Able and willing to complete a log journal. 4. Written informed consent signed and dated prior to study enrollment in accordance with GCP and local legislation
Exclusion criteria
Exclusion criteria: Patient with a history or clinical suspicion at the time of medical evaluation of the following entities: 1. Eating disorders such as anorexia nervosa and bulimia, as a cause of excessive use of laxatives. 2. Patients whose constipation is caused by a primary organic disease of the colon or pelvic floor. 3. Patients with metabolic disorders, neurological disorders, serious psychiatric disorders, or any other significant or intercurrent illness (eg, abdominal / gastrointestinal surgery) that, in the opinion of the investigators, would interfere with participation in the trial. 4. Patients with a disability that restricts their spontaneous mobility (eg, in a wheelchair or in bed) 5. Patients with known hypersensitivity to sodium picosulfate, bisacodyl, or any other ingredient in the study medication. 6. Patients with ileus, intestinal obstruction, acute surgical abdominal conditions (such as acute appendicitis and acute inflammatory bowel diseases) or severe dehydration 7. Patients with anal fissures or ulcerative proctitis with mucosal damage. 8. Patients with known clinically significant abnormal electrolyte values. 9. Patients whose concomitant therapy includes an opioid medication (eg, morphine, codeine) or anticholinergics 10. Patients unwilling to discontinue use of prohibited concomitant therapy 11. Pregnant or lactating women 12. Participate concomitantly in another trial 13. Drug or alcohol abuse 14. Concomitant use of antibiotics 15. Therapy with other drugs of similar action within 02 weeks before the screening visit .16. Use of potassium-sparing diuretics or potassium supplements, chronic or excessive use of laxatives can reduce the serum concentration of potassium by promoting an excessive loss of potassium in the intestinal tract. 17. Use of Antiarrhythmics (quinidine type): Sotalol, amiodarone, vincamine, digitalis. 18. Inflammatory bowel diseases (ulcerative colitis, Crohn's disease).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Self Report / e-CRF NAME OF THE RESULT: Average number of CSBMs per week PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: During study treatment (4 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| PAC-QOL NAME OF THE RESULT: Change from baseline in patients' weekly score for overall satisfaction with bowel habits and discomfort of constipation symptoms PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: During study treatment (4 weeks) ;PAC-SYM NAME OF THE RESULT: Change from Baseline in Weekly Mean Score for Constipation Symptoms PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: During study treatment (4 weeks) ;Self Report / e-CRF NAME OF THE RESULT: Number of early withdrawals from the trial PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: During study treatment (4 weeks) ;Self Report / e-CRF NAME OF THE RESULT: Number of patients with = 3 CSBM per week PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: In 7 days ;Self Report / e-CRF NAME OF THE RESULT: Number of patients with = 1 CSBM per day PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: In 24 hours ;Self Report / e-CRF NAME OF THE RESULT: Time to first spontaneous bowel movement after first intake of study drug. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Until the first spontaneous evacuation. ;Self Report / e-CRF NAME OF THE RESULT: Average number o | — |
Countries
Peru
Contacts
Public ContactRAUL FLORENTINO HERNAN YEPEZ
LABORATORIOS FARMACEUTICOS MARKOS S.A
Outcome results
None listed