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This study aims to evaluate the efficacy and safety of the docusate sodium and sorbitol rectal solution produced by Ferring Pharmaceutical (China) Ltd. in treating Chinese patients with constipation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Docusate sodium and sorbitol rectal solution | Experimental |
| |
| Glycerine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glycerine | Drug |
| ||
| Docusate sodium and sorbitol rectal solution |
| Measure | Description | Time Frame |
|---|---|---|
| Overall efficacy rate of the enema in treating the symptoms of constipation | Up to 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Time from conclusion of enema administration to patient's first bowel movement | Up to 30 minutes | |
| Amount of straining that occurs during bowel movement (normal/difficult) | Up to 30 minutes | |
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Inclusion Criteria:
Have signed the informed consent form and have been verbally told of the details of the trial and treatment procedures
Is a citizen of the People's Republic of China
Males and females aged between 18 and 65 years inclusive
A history of constipation symptoms for at least 6 months, with occurrence of two or more of the symptoms during the 3 months before screening:
No bowel movement within two days prior to randomisation
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern Medical University - Nanfang Hospital | Guangzhou | Guangdong | China | |||
| The First Affiliated Hospital, Sun Yat-sen University |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005990 | Glycerol |
| D004143 | Dioctyl Sulfosuccinic Acid |
| ID | Term |
|---|---|
| D000073999 | Triose Sugar Alcohols |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
| Feeling of emptying of the rectum post bowel movement (complete/incomplete) |
| Up to 30 minutes |
| Stool form after enema treatment according to Bristol Stool Scale | Up to 30 minutes |
| Anal complaints (absent, anal itch, anal irritation or anal pain) | Up to 30 minutes |
| Abdominal pain (absent, mild, moderate, or severe) | Up to 30 minutes |
| Patient's overall assessment of using the enema to treat the symptoms of constipation | Up to 30 minutes |
| Guangzhou |
| Guangdong |
| China |
| The Second Affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong | China |
| Zhongnan Hospital of Wuhan University | Wuhan | Hubei | China |
| Nanjing First Hospital | Nanjing | Jiangsu | China |
| The First Affiliated Hospital with Nanjing Medical University | Nanjing | Jiangsu | China |
| Shanghai Changhai Hospital | Shanghai | Shanghai Municipality | China |
| Shanghai Jiaotong University Medical School - Renji Hospital | Shanghai | Shanghai Municipality | China |
| Shanghai Jiaotong University Medical School - Ruijin Hospital | Shanghai | Shanghai Municipality | China |
| D002241 |
| Carbohydrates |
| D013386 | Succinates |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |