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The investigators will enroll subjects 8 - < 18 years of age, fulfilling Rome IV criteria for functional constipation.
Participants will be randomly assigned to either Lubiprostone treatment (study group), or the control group (will receive either lactulose or Bisacodyl tablets).
safety and efficacy will be assessed.
The investigators will enroll 274 subjects who will be randomly divided equally into interventional and control groups.
Participants and their parents/legal guardians will be instructed to administer the doses at least 5 hours apart with meals and a large volume of fluid.
The control group will receive lactulose 1 mL/kg, once or twice daily (maximum 60 mL/day or Bisacodyl tablet (5 mg/tablet) in a dose of 2 tab/day for < 12 years or 3 tab/day for > 12 years.
Both arms will receive the treatment for 12 weeks followed by 4 weeks follow-up after the end of treatment (week 16).
Participants (and their guardians) will be instructed to regularly document the number of spontaneous bowel motions/week and to define their Bristol chart category for every bowel motion. In addition, the participants will be encouraged to contact the trial team if any adverse events appeared. This is in addition to regular visits at 0, 2, 8, 12 weeks for assessment of safety (efficacy will be assessed at weeks 8, 12, and 16).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Arm | Experimental |
|
|
| Control Arm | Active Comparator | Subjects will receive the conventional therapy (one or a combination of the following):
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lubiprostone Pill | Drug | Oral pills for constipation (Lubiprostone) will be given in a dose range from 24 mcg once daily to 24 mcg twice daily according to the participant weight. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary outcome | Spontaneous bowel motions (SBM) ≥ 1 SBM/week increase in the frequency compared with baseline, and ≥ 3 SBMs/week for at least 8 weeks, including the last 4 study weeks and the 4 weeks of follow-up. | At study week 16. |
| Measure | Description | Time Frame |
|---|---|---|
| Early spontaneous bowel motions | Number of participants who experienced first SBM within 48 hours after dose initiation. | First 48 hours after first drug dose. |
| First dose response time | The time between first dose of treatment and the first SBM. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sameh A. Lashen, MD (Ph.D.) | Faculty of Medicine, Alexandria University - Alexandria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexandria Main University Hospital | Alexandria | 21521 | Egypt | |||
| Faculty of Medicine |
patient personal and identification data will not be available for sharing
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| ID | Term |
|---|---|
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D000068238 | Lubiprostone |
| D002214 | Capsules |
| D007792 | Lactulose |
| D001726 | Bisacodyl |
| C005701 | picosulfate sodium |
| ID | Term |
|---|---|
| D000527 | Alprostadil |
| D005229 | Fatty Acids, Monounsaturated |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
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Patients assigned to lubiprostone will receive a dose based on their weight at the time of enrollment. patients weighing <50 kg and ≥ 50 kg will be given lubiprostone at doses of 8 mg TID and 24 mg BID, respectively.
Patients and their parents/legal guardians will be instructed to administer the doses at least 5 hours apart with meals and large volume of fluid.
The control group will receive the conventional therapy (lactulose 1 mL/kg, once or twice daily (maximum 60 mL/day), or Bisacodyl tablet (5 mg/tablet) in a dose of 2 tab/day for < 12 years or 3 tab/day for > 12 years.
Both arms will receive the treatment for 12 weeks followed by 4 weeks follow-up after the end of treatment (week 16).
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|
| Lactulose Oral Liquid Product | Drug | Lactulose " Lactulose, or Duphalac syrup" at a dose of 1 ml/kg once or twice daily (maximum 60 mL/day) |
|
|
| Bisacodyl 5 MG | Drug | Bisacodyl tablet (5 mg/tablet) in a dose of 2 tab/day for < 12 years or 3 tab/day for > 12 years |
|
|
| Sodium Picosulfate | Drug | Sodium Picosulfate 0.75% drops in a daily dose of 2.5-20 mg/day |
|
|
| 1st week of treatment |
| Number of Spontaneous Bowel Motions/Week. | Number of Spontaneous Bowel Motions/Week. | At study week Week 8, 12. |
| Responders rate | Responders rate at week 8, 12, 16. | At study week Week 8, 12, 16. |
| Alexandria |
| 21521 |
| Egypt |
| D008055 |
| Lipids |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D000073893 | Sugars |
| D003408 | Cresols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |