Chronic constipation
Conditions
Interventions
Trade Name: Movicol® 13.8g sachet, powder for oral solution
Pharmaceutical Form: Powder for oral solution
CAS Number: 0
Other descriptive name: MACROGOL 3350
Concentration unit: g gram(s)
Concentrati
Sponsors
Schering-Plough HealthCare Products, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A willingness to participate in the study and comply with its procedures. 2. Male or female. 3. Aged 18 years or older at the signing of the ICF on Visit 1. 4. Must be ambulatory. 5. Have stools less often than three times weekly and meet one or more of the following modified Rome III-based criteria for constipation: a. Straining during all 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 (eg, digital evacuation, support of the pelvic floor) 6. Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis 7. Agrees not to use any treatment known to cause constipation during the course of the study, beginning at pre-study (Visit 1) 8. Agrees not to use laxatives other than the study treatment from baseline/informed consent (Visit 2) to end of study (Visit 4). 9. Agrees to maintain a similar diet from the week prior to randomization through end of study. 10. If a female subject, either surgically sterile, 2 years postmenopausal, or using an acceptable method of contraception (including hormonal birth control, IUD, double barrier methods, or vasectomized partner). Abstinence is not an acceptable method of contraception. Females of childbearing potential must have a urine pregnancy test (human chorionic gonadotropin [HCG]) that is negative at Visit 3. 11. Be able to read and write in the diaries in English. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Have loose stools without the use of laxatives. 2. Recurrent abdominal pain (if it is the predominant symptom of constipation). 3. Known or suspected bowel perforation, obstruction, or fecal impaction; or had gastric retention, inflammatory bowel disease, bowel resection, or colostomy. 4. Celiac disease or known gluten sensitivity. 5. Known renal or hepatic insufficiency. 6. Recent history of alcohol abuse (in the Investigator’s opinion) or drug abuse. 7. History of psychiatric disorders. Currently clinically stable subjects (in the Investigator’s opinion) can be included. 8. History of significant (in the Investigator’s opinion) ongoing medical problems (including acute infections, renal or gastrointestinal disease) or who are scheduled for surgical procedures. All clinically significant medical of surgical conditions in the opinion of the investigator, abnormalities merit exclusion. 9. Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures. 10. Participated in an investigational clinical, surgical, drug or device study within the past 30 days. 11. Pregnant or lactating. 12. Allergic to PEG or PEG + E. 13. Employed by or have immediate family members employed by a company that manufactures laxative products. 14. Subject or family member of the Investigator or site staff directly involved with this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the proportion of subjects with a bowel movement (BM) without straining or without hard and or lumpy stool within the first 24 hours of treatment for subjects taking one of three single doses of PEG+E (Movicol 13.8 g - 1, 2 or 3 sachets).;Secondary Objective: Secondary objectives will be measured by analysis of a subject diary and self-reported BM data. The secondary objectives include comparisons of PEG+E doses at 24 hours for: - bowel movement control; - relief of gas; - relief of bloating; and, - relief of abdominal discomfort/cramping. In addition, the proportion of subjects with a BM (without straining and without hard and/or lumpy stool) within the first 24 hours of treatment for subjects taking different doses of PEG+E will be evaluated for the time to first BM.;Primary end point(s): Proportion of subjects with successful BM (i.e. BM with no straining or hard/lumpy stools) within 24 hours of dosing. | — |
Countries
Ireland
Outcome results
None listed