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The purpose of this study is to determine whether Forlax® is more effective than placebo in relieving chronic constipation in children who may also suffer from soiling or faecal incontinence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG 4000 (Forlax®) | Drug | Powder for oral solution. 2 sachets of 4g, from baseline every two weeks over a 4 week treatment period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bowel movement frequency | week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective symptoms associated with defecation. | At every visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ramathibodi Hospital, Mahidol University, | Bangkok | 10400 | Thailand | |||
| Maharat Nakhon Ratchasima Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24943105 | Derived | Treepongkaruna S, Simakachorn N, Pienvichit P, Varavithya W, Tongpenyai Y, Garnier P, Mathiex-Fortunet H. A randomised, double-blind study of polyethylene glycol 4000 and lactulose in the treatment of constipation in children. BMC Pediatr. 2014 Jun 19;14:153. doi: 10.1186/1471-2431-14-153. |
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| Lactulose active and Lactulose placebo | Drug | Powder for oral solution. 1 sachet of 3.3g lactulose active and 1 sachet of lactulose placebo. From baseline every two weeks over a 4 week treatment period. |
|
| Nakhon Ratchasima |
| 30000 |
| Thailand |
| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| ID | Term |
|---|---|
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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