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| Name | Class |
|---|---|
| Sucampo AG | INDUSTRY |
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A study of the safety of lubiprostone in pediatric participants aged ≥ 6 Years to < 18 years diagnosed with functional constipation.
To assess the long-term safety and tolerability of oral lubiprostone 12 or 24mcg capsules dosed twice daily (BID) when administered orally for 24 weeks in pediatric participants with functional constipation. Evaluation of lubiprostone safety and tolerability is the primary objective in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lubiprostone | Experimental | Participants received lubiprostone twice daily (BID). Participants received either lubiprostone 12 mcg BID, lubiprostone 24 mcg BID (dose based on participant's weight) up to 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lubiprostone | Drug | 12 or 24 mcg soft capsules for oral administration. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE) | Adverse events with onset dates after the administration of the first dose of study medication or prior to the last day of treatment plus 7 days are considered treatment-emergent. | within 25 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Team Leader | Mallinckrodt | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwest Arkansas Pediatric Clinic | Fayetteville | Arkansas | 72703 | United States | ||
| Methodist Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lubiprostone | Participants received lubiprostone twice daily (BID). Participants received either lubiprostone 12 mcg BID, lubiprostone 24 mcg BID (dose based on participant's weight) up to 24 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Peoria |
| Illinois |
| 61602 |
| United States |
| Willis-Knighton Physician Network | Shreveport | Louisiana | 71101 | United States |
| Pioneer Clinical Research | Bellevue | Nebraska | 68005 | United States |
| PriMed Clinical Research | Beavercreek | Ohio | 45431 | United States |
| Cyn3rgy Research | Gresham | Oregon | 97030 | United States |
| Coastal Clinical Research | Charleston | South Carolina | 29414 | United States |
| Coastal Pediatrics Associates - Mount Pleasant | Mt. Pleasant | South Carolina | 29464 | United States |
| Spartanburg Medical Research | Spartanburg | South Carolina | 29303 | United States |
| 3rd Coast Research Associates | Corpus Christi | Texas | 78413 | United States |
| Bridgerland Clinical Research | Logan | Utah | 84341 | United States |
| Wee Care Pediatrics | Syracuse | Utah | 84075 | United States |
| Pediatric Research of Charlottesville, LLC | Charlottesville | Virginia | 22902 | United States |
| Treated (Safety [SAF] Population) |
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| COMPLETED |
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| NOT COMPLETED |
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Safety (SAF) population, defined as all enrolled participants who took at least one dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Lubiprostone | Participants received lubiprostone twice daily (BID). Participants received either lubiprostone 12 mcg BID, lubiprostone 24 mcg BID (dose based on participant's weight) up to 24 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE) | Adverse events with onset dates after the administration of the first dose of study medication or prior to the last day of treatment plus 7 days are considered treatment-emergent. | Safety population. | Posted | Count of Participants | Participants | within 25 weeks |
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From the first dose of study drug up to 25 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lubiprostone | Participants received lubiprostone 12 mcg or 24 mcg BID (dose based on participant's weight) up to 24 weeks. | 0 | 87 | 2 | 87 | 24 | 87 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| Blood iron decreased | Investigations | MedDRA (19.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information Call Center | Mallinckrodt Pharmaceuticals | 800-556-3314 | clinicaltrials@mnk.com |
| ID | Term |
|---|---|
| D000068238 | Lubiprostone |
| ID | Term |
|---|---|
| D000527 | Alprostadil |
| D005229 | Fatty Acids, Monounsaturated |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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| Unknown or Not Reported |
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| Other |
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