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The aim of the study is to show that new polyethylene glycol (PEG) solution without electrolytes is as effective in the treatment of constipation as PEG solution with electrolytes in the elderly institutionalized people. Also, the tolerability and the safety of the study drug will be examined.
Constipation is a major problem in elderly institutionalised patients. Non-pharmacological treatments are proposed as primary management of constipation, but institutionalised patients are not likely to be able to increase either the intake of dietary fibre or fluid and their physical activity is low.
The latest agent widely used for the treatment of constipation is polyethylene glycol (PEG). PEG is classified into the group of osmotic laxatives. It is minimally absorbed from the gastrointestinal tract and not metabolised by colonic bacteria.
Most of the PEG products at the market contain electrolytes and have a salty and unpleasant taste which may affect the compliance of using them. A PEG solution without electrolytes has been developed and used for some years in various countries. Now we will compare the efficacy and safety of PEG solutions with or without electrolytes and their acceptability in the use for constipation in institutionalised patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T | Experimental | Test product |
|
| C | Active Comparator | Reference product |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyethylene glycol 4000 | Drug | powder for oral solution 12 g of PEG once a day, twice a day or once every other day for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stool frequency | week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Stool frequency | Week 2 | |
| Stool straining | Weeks 2 and 4 | |
| Stool consistency |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lauri Seinelä, MD | Pirkanmaan erikoislääkäripalvelu Oy | Principal Investigator |
| Ulla Sairanen, MSc | Orion Corporation, Orion Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Koskikoti | Tampere | 33100 | Finland | |||
| Koivupirtti |
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| Polyethylene glycol 4000 with electrolytes | Drug | granules for oral solution 12 g of PEG once a day, twice a day or once every other day for 4 weeks |
|
|
| Weeks 2 and 4 |
| Tampere |
| 33500 |
| Finland |
| Tampereen sotainvalidien Veljeskoti | Tampere | 33500 | Finland |
| Lahdensivun koti | Tampere | 33560 | Finland |
| Nurmikoti | Tampere | 33680 | Finland |
| Vire Koti Kaukaharju assisted-living facility | Tampere | 33710 | Finland |
| Taatala assested-living facility | Tampere | 33820 | Finland |
| Kuusela assisted-living facility | Tampere | 33900 | Finland |
| Petäjäkoti | Tampere | 33900 | Finland |
| Nursing home of Tiuravuori | Ylöjärvi | 33480 | Finland |
| 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 |
|---|---|
| C000595214 | polyethylene glycol 4000 |
| D004573 | Electrolytes |
| ID | Term |
|---|---|
| D007287 | Inorganic Chemicals |
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