Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a randomised, assessor-blind, multi-centre pilot study to investigate the comparative safety and efficacy of KLYX and glycerine enema in the symptomatic treatment of constipation in Chinese patients.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KLYX | Experimental |
| |
| Glycerine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KLYX | Drug |
| ||
| Glycerine |
| Measure | Description | Time Frame |
|---|---|---|
| Overall efficacy of enema | immediately following enema administration |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first bowel movement | Immediately following enema administration | |
| Patient's overall satisfaction with enema treatment | Immediately following enema administration | |
Not provided
Inclusion Criteria:
Have signed the informed consent form and have been verbally explained the details of the trial and treatment procedures
Ethnically Chinese
Males or females aged between 18 and 65 years inclusive
A history of constipation symptoms for at least 6 months fulfilling, with occurrence of two or more of the following symptoms during the 3 months before screening (the 3 months need not be consecutive):
i. Very hard (pellet-like) and/or hard stools (Type 1 or 2 of the Bristol Stool Scale) for at least 25% of the time; or ii. Sensation of incomplete evacuation at least 25% of the time; or iii. Straining during defecation at least 25% of the time; or iv. Sensation of anorectal obstruction or blockage often during defecation at least 25% of the time; or v. Manual manoeuvres needed often to facilitate defecations (e.g. digital evacuation, support of the pelvic floor) at least 25% of the time; or vi. Fewer than 3 defecations per week.
Patient has had no bowel movement (i.e. still constipated) two days prior randomisation.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai Hospital, The Second Military Medical University | Shanghai | China | ||||
| Renji Hospital, Shanghai Jiaotong University School of Medicine |
Not provided
| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D005990 | Glycerol |
| ID | Term |
|---|---|
| D000073999 | Triose Sugar Alcohols |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Stool form after enema treatment |
| Immediately following enema administration |
| Shanghai |
| China |
| Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Shanghai | China |
| D002241 |
| Carbohydrates |