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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-000081-63 | EudraCT Number |
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The study design combines a long-term safety and a dose range determination objective. The first 8 weeks of the study were primarily intended for the dose range determination, while the later visits were used for the comparison of long-term safety between the groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Macrogol (Transipeg) | Experimental |
| |
| Macrogol (Forlax) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Macrogol (Transipeg, BAY81-8430) | Drug | Up to 4 sachets per day based on individual titration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Symptom Based Weekly Total Sum Score (TSS) Over 52 Weeks | Baseline (Week 0), Week 1, 2, 3, 4, 8, 12, 26, 52 | |
| Change From Baseline in Total Sum Score (TSS) at Week 52 | Baseline, Week 52 | |
| Short Term Change of Total Sum Score (TSS): Average of Weeks 1 to 8 Minus Baseline | Average of Weeks 1 to 8 | |
| Long Term Change of Total Sum Score (TSS): Average of Weeks 26 and 52 Minus Baseline | Average of Weeks 26 and 52 | |
| Overall Change of Total Sum Score (TSS): Average of all Diaries Obtained Minus Baseline | Average up to 52 weeks | |
| Dose Range Determination: Mean Dose Based on Sachets Used | Up to 52 weeks. | |
| Dose Range Determination: Mean Dose per Kilogram Body Weight Based on Sachets Used | Up to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Treatment Success | Week 1, 2, 4, 8, 12, 26, 52 | |
| Individual Symptoms: Defecation Frequency | Week 1, 2, 4, 8, 12, 26, 52 | |
| Individual Symptoms: Consistency of the Feces |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam | 1105 AZ | Netherlands | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28906317 | Derived | Bekkali NLH, Hoekman DR, Liem O, Bongers MEJ, van Wijk MP, Zegers B, Pelleboer RA, Verwijs W, Koot BGP, Voropaiev M, Benninga MA. Polyethylene Glycol 3350 With Electrolytes Versus Polyethylene Glycol 4000 for Constipation: A Randomized, Controlled Trial. J Pediatr Gastroenterol Nutr. 2018 Jan;66(1):10-15. doi: 10.1097/MPG.0000000000001726. |
| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
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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 |
|---|---|
| D011092 | Polyethylene Glycols |
| ID | Term |
|---|---|
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Macrogol (Forlax) | Drug | Up to 4 sachets per day based on individual titration |
|
| Week 1, 2, 4, 8, 12, 26, 52 |
| Individual Symptoms: Strains During Defecation | Week 1, 2, 4, 8, 12, 26, 52 |
| Individual Symptoms: Quantity of Stools | Week 1, 2, 4, 8, 12, 26, 52 |
| Individual Symptoms: Percentage of Subjects With Pain During Defecation | Week 1, 2, 4, 8, 12, 26, 52 |
| Individual Symptoms: Frequency of Pain (Times per Week) | Week 1, 2, 4, 8, 12, 26, 52 |
| Percentage of Subjects With Abdominal Pain | Week 1, 2, 4, 8, 12, 26, 52 |
| Individual Symptoms: Frequency of Abdominal Pain (Times per Week) | Week 1, 2, 4, 8, 12, 26, 52 |
| Individual Symptoms: Relation of Abdominal Pain With Defecation | Week 1, 2, 4, 8, 12, 26, 52 |
| Individual Symptoms: Fecal Incontinence (Times per Week) and Fecal Incontinence (Times per Week) at Night | Week 1, 2, 4, 8, 12, 26, 52 |
| Individual Symptoms: Percentage of Subjects with Fecal Incontinence at Specified Time points | Week 1, 2, 4, 8, 12, 26, 52 |
| Individual Symptoms: Percentage of Subjects With Urgency for Defecation | Week 1, 2, 4, 8, 12, 26, 52 |
| Individual Symptoms: Frequency of Urgency for Defecation (Times per Week) | Week 1, 2, 4, 8, 12, 26, 52 |
| Individual Symptoms: Percentage of Subjects With Urine Incontinence (UI) During Day and Night | Week 1, 2, 4, 8, 12, 26, 52 |
| Individual Symptoms: Frequency of Urine Incontinence During Day and Night (Times per Week) | Week 1, 2, 4, 8, 12, 26, 52 |
| Individual Symptoms: Percentage of Subjects With Good, Moderate or Bad Appetite | Week 1, 2, 4, 8, 12, 26, 52 |
| Individual Symptoms: Average Score for Diary Reported Diarrhoea | Week 0, 1, 2, 4, 8, 12, 26, 52 |
| Individual Symptoms: Average Score for Diary Reported Flatulence | Week 0, 1, 2, 4, 8, 12, 26, 52 |
| Individual Symptoms: Average Score for Diary Reported Nausea | Week 0, 1, 2, 4, 8, 12, 26, 52 |
| Eindhoven |
| 5623 EJ |
| Netherlands |
| Veldhoven | 5504 DB | Netherlands |
| Woerden | 3447 GN | Netherlands |
| D011108 |
| Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |