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| Name | Class |
|---|---|
| PT Meiji Indonesia | UNKNOWN |
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The aim of this study is to determine the efficacy and safety of PEG 3350 (polyethylene glycol 3350) for short-term treatment of chronic constipation in adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEG 3350 | Experimental | The content of each sachet of PEG 3350 (17 g powder) is dissolved in 240 mL of water, drink it once daily at bedtime, for a duration of 14 days. |
|
| Lactulax | Active Comparator | 15 ml of Lactulax syrup (containing 10 g of lactulose) is drunk with 240 ml of water once daily at bedtime, for a duration of 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG 3350 | Drug | PEG 3350 17 g once daily for 14 days |
| |
| Lactulose |
| Measure | Description | Time Frame |
|---|---|---|
| Change of number of bowel movements at 1 week | An increase in the number of bowel movements (defecation) per 7-day period indicates a positive result. | 7 days |
| Change of number of bowel movements at 2 weeks | An increase in the number of bowel movements (defecation) per 7-day period indicates a positive result. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom scores at 1 week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | The following adverse events may occur after treatment, thus will be evaluated:
| 7 days, 14 days |
| Number of participants with serious adverse events (SAEs) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Murdani Abdulah | Fakultas Kedokteran Universitas Indonesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Puskesmas Kelurahan Petamburan | Jakarta | DKI Jakarta | 10260 | Indonesia | ||
| RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 28, 2019 | Jul 1, 2019 | Prot_SAP_001.pdf |
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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 |
|---|---|
| C000595212 | polyethylene glycol 3350 |
| D007792 | Lactulose |
| ID | Term |
|---|---|
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Drug |
Lactulose 10 g once daily for 14 days |
|
| 7 days |
| Symptom scores at 2 weeks |
| 14 days |
| Overall rating of effectiveness at 1 week | Effective: patients with ≥ 3 bowel movements per 7-day period | 7 days |
| Overall rating of effectiveness at 2 weeks | Effective: patients with ≥ 3 bowel movements per 7-day period | 14 days |
| 7 days, 14 days |
| Jakarta |
| DKI Jakarta |
| 10430 |
| Indonesia |
| Puskesmas Kelurahan Paseban | Jakarta | DKI Jakarta | 10440 | Indonesia |
| D000073893 |
| Sugars |