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| ID | Type | Description | Link |
|---|---|---|---|
| CL2012-15 | Other Identifier | Consumer Health Protocol Number | |
| 8114-005 | Other Identifier | Merck |
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The purpose of this study is to evaluate the complete resolution of constipation in participants taking PEG 3350 compared to those taking PEG 4000, based on analysis of the number of bowel movements from self-reported bowel movement (BM) data. The complete resolution of constipation is defined as the elimination of straining or of hard/lumpy stools.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEG 3350 | Experimental | Participants will receive a 17 g oral dose of 1 sachet of PEG 3350 mixed in 120 to 240 mL of water, once a day, for 7 days. |
|
| PEG 4000 | Active Comparator | Participants will receive a 10 to 20 g oral dose of 1 to 2 sachets of PEG 4000 mixed in 120 to 140 mL of water, once a day, for 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyethylene Glycol 3350 Powder for Solution (PEG 3350) | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of bowel movements per week | Up to 7 days after start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first bowel movement | Up to 7 days after start of treatment | |
| Number of participants who experience changes in straining and hard or lumpy stools | Up to 7 days after start of treatment | |
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Inclusion Criteria:
Exclusion Criteria: - currently under a doctor's care and treatment for constipation.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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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 |
|---|---|
| D012996 | Solutions |
| C000595212 | polyethylene glycol 3350 |
| D011092 | Polyethylene Glycols |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
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| Polyethylene Glycol 4000 Powder for Solution (PEG 4000) |
| Drug |
|
|
| Number of participants who experience changes in stool consistency |
| Up to 7 days after start of treatment |
| Number of participants who experience changes in the sensation of stool evacuation | Up to 7 days after start of treatment |
| D009930 |
| Organic Chemicals |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |