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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004384-31 | EudraCT Number |
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| Name | Class |
|---|---|
| Takeda | INDUSTRY |
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This study is for children with constipation.
Children who completed 3 months of treatment in the earlier study (NCT02042183):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lubiprostone | Experimental | Participants receive lubiprostone twice daily Participants must have completed the entire 12-week treatment period during the preceding study. Those who received 12 mcg twice daily (BID) continued to receive 12 mcg, those who received 24 mcg BID continued with that dose.Those of the placebo arm in the previous study weighing less than 50 kg received 12 mcg BID and over 50 kg received 24 mcg BID during this study. |
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| 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 |
|---|---|---|
| Median Number of Observed Weekly Spontaneous Bowel Movements (SBM) Per Month | Spontaneous bowel movements are defined as bowel movements without the aid of drugs. | within 9 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Median Monthly Score on a 5-point Straining Scale Associated With Observed SBMs | Straining during observed SBMs is rated on a 5-point scale where 1=no straining and 5=extreme straining. A higher value is worse. | within 9 months |
| Median Monthly Score on a Stool Consistency Scale Associated With Observed SBMs |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Leader | Mallinckrodt | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Alabama Women's and Children's Hospital | Mobile | Alabama | 36604 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33838349 | Derived | Benninga MA, Hussain SZ, Sood MR, Nurko S, Hyman P, Clifford RA, O'Gorman M, Losch-Beridon T, Mareya S, Lichtlen P, Di Lorenzo C. Lubiprostone for Pediatric Functional Constipation: Randomized, Controlled, Double-Blind Study With Long-term Extension. Clin Gastroenterol Hepatol. 2022 Mar;20(3):602-610.e5. doi: 10.1016/j.cgh.2021.04.005. Epub 2021 Apr 7. |
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Participants who completed the 3-month placebo-controlled study (NCT02042183) were invited to enroll in this safety extension study lasting an additional 9 months.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Participants received lubiprostone |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 23, 2015 |
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Stool consistency is rated on a 5-Point Stool Consistency Scale, where 1=normal and 5=very hard. Higher scores mean a worse outcome. |
| within 9 months |
| Median Monthly Score on a 4-point Pain Scale for Observed Abdominal Pain | Abdominal pain was rated on a scale from 1 (no pain) to 4 (very severe pain). A higher score means a worse outcome. | within 9 months |
| Arizona Children's Center at Maricopa Medical Center |
| Phoenix |
| Arizona |
| 85008 |
| United States |
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | United States |
| Northwest Arkansas Pediatric Clinic | Fayetteville | Arkansas | 72703 | United States |
| Arkansas Childrens Hospital Research Institute | Little Rock | Arkansas | 72202 | United States |
| WCCT Global | Costa Mesa | California | 92626 | United States |
| Loma Linda University Health Care | Loma Linda | California | 92350 | United States |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | United States |
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| MCB Clinical Research | Colorado Springs | Colorado | 80910 | United States |
| Nemours/Alfred I. duPont Hospital for Children | Wilmington | Delaware | 19803 | United States |
| Emmerson Clinical Research | Washington D.C. | District of Columbia | 20020 | United States |
| University of Florida | Gainesville | Florida | 32610 | United States |
| Palmetto Professional Research | Hialeah | Florida | 33016 | United States |
| Nemours Children's Clinic | Jacksonville | Florida | 32207 | United States |
| Acevedo Clinical Research Associates | Miami | Florida | 33142 | United States |
| Savin Medical Group Research Center | Miami Lakes | Florida | 33014 | United States |
| Nemours Childrens Clinic | Pensacola | Florida | 32504 | United States |
| Children's Center for Digestive Health Care/GI Care for Kids | Atlanta | Georgia | 30342 | United States |
| Methodist Medical Center | Peoria | Illinois | 61602 | United States |
| PediaResearch, LLC - Newburgh | Newburgh | Indiana | 47630 | United States |
| UnityPoint Health Des Moines/ Blank Children's Clinic | Des Moines | Iowa | 50309 | United States |
| University of Iowa Children's Hospital | Iowa City | Iowa | 52242 | United States |
| Heartland Research Associates | Wichita | Kansas | 67205 | United States |
| University of Louisville Research Foundation Inc. Kosair Charities Pediatric Clinical Research Unit | Louisville | Kentucky | 40202 | United States |
| PediaResearch, LLC - Owensboro | Owensboro | Kentucky | 42301 | United States |
| Willis-Knighton Physician Network | Shreveport | Louisiana | 71101 | United States |
| Virgo-Carter Pediatrics | Silver Spring | Maryland | 20910 | United States |
| Gastrointestinal Associates, PA | Jackson | Mississippi | 39202 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| The Children's Mercy Hospital | Kansas City | Missouri | 64145 | United States |
| Pioneer Clinical Research | Bellevue | Nebraska | 68005 | United States |
| Smart Medical Research, Inc. | Jackson Heights | New York | 11372 | United States |
| NY Presbyterian Weill Cornell | New York | New York | 10021 | United States |
| Morgan Stanley Children's Hospital of New York Presbyterian | New York | New York | 10032 | United States |
| PriMed Clinical Research | Beavercreek | Ohio | 45431 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| Toledo Children's Hospital | Toledo | Ohio | 43606 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Cyn3rgy Research | Gresham | Oregon | 97030 | United States |
| Square-1 Clinical Research, Inc. | Erie | Pennsylvania | 16506 | United States |
| St. Christopher's Hospital for Children Drexel University | Philadelphia | Pennsylvania | 19134 | United States |
| Children's Hospital of Pittsburgh UPMC | Pittsburgh | Pennsylvania | 15224 | United States |
| AAPRI Clinical Research | Warwick | Rhode Island | 02886 | United States |
| Coastal Pediatric Associates - James Island | Charleston | South Carolina | 29412 | United States |
| Coastal Clinical Research | Charleston | South Carolina | 29414 | United States |
| Greenville Health System | Greenville | South Carolina | 29615 | United States |
| Coastal Pediatrics Associates - Mount Pleasant | Mt. Pleasant | South Carolina | 29464 | United States |
| Spartanburg Medical Research | Spartanburg | South Carolina | 29303 | United States |
| The Jackson Clinic, P.C. | Jackson | Tennessee | 38305 | United States |
| 3rd Coast Research Associates | Corpus Christi | Texas | 78413 | United States |
| Childrens Medical Center Dallas | Dallas | Texas | 75390 | United States |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Envision Clinical Research, LLC | Laredo | Texas | 78041 | United States |
| DCOL Center for Clinical Research | Longview | Texas | 75605 | United States |
| Bridgerland Clinical Research | Logan | Utah | 84341 | United States |
| Primary Children's Medical Center | Salt Lake City | Utah | 84132 | United States |
| Wee Care Pediatrics | Syracuse | Utah | 84075 | United States |
| University of Vermont Medical Center | Burlington | Vermont | 05445 | United States |
| Pediatric Research of Charlottesville, LLC | Charlottesville | Virginia | 22902 | United States |
| INOVA Pediatric Digestive Diseases Center | Fairfax | Virginia | 22031 | United States |
| Pediatric Gastroenterology Carilion Medical Center | Roanoke | Virginia | 24014 | United States |
| Northwest Clinicial Research Center | Bellevue | Washington | 98007 | United States |
| Zain Research LLC | Richland | Washington | 99352 | United States |
| MultiCare Health System Institute for Research and Innovation | Tacoma | Washington | 98405 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Universitair Kinderziekenhuis Brussel | Brussels | 01090 | Belgium |
| CHC - Clinique Saint-Joseph | Montegnée | 04420 | Belgium |
| Sainte Justine University Health Center | Montreal | H3T1C5 | Canada |
| CHU-Bordeaux | Bordeaux | 33000 | France |
| Emma Children's Hospital | Amsterdam | 1105 AZ | Netherlands |
| Amphia Ziekenhuis | Breda | 4800 RK | Netherlands |
| Maasstad Hospital Rotterdam | Rotterdam | 3079 DZ | Netherlands |
| Isala Klinieken | Zwolle | 8025 AB | Netherlands |
| Medical University of Bialystok | Bialystok | 15-274 | Poland |
| Szpital Uniwersytecki | Bydgoszcz | 85-168 | Poland |
| Szpital Pediatryczny ICZMP | Lodz | 93-338 | Poland |
| Gabinet Lekarski Bartosc Korczowski | Rzeszów | 35-210 | Poland |
| Przychodnia Specjalistyczna PROSEN | Warsaw | 01-231 | Poland |
| Children's Memorial Health Institute | Warsaw | 04-730 | Poland |
| Darlington Memorial Hospital | Darlington | DL3 6HZ | United Kingdom |
| Royal London Hospital | London | E1 1BB | United Kingdom |
| Chelsea and Westminster Hospital NHS Foundation Trust | London | SW10 9NH | United Kingdom |
| Sheffield Children Hospital | Sheffield | S10 2TH | United Kingdom |
| Safety Analysis Set |
|
| Modified Intent to Treat (mITT) | One participant excluded for serious compliance issues with potential data integrity impact |
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| COMPLETED |
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| NOT COMPLETED |
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mITT population
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Participants receive lubiprostone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Number | 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 | Median Number of Observed Weekly Spontaneous Bowel Movements (SBM) Per Month | Spontaneous bowel movements are defined as bowel movements without the aid of drugs. | mITT with evaluable data at the given time point | Posted | Median | Full Range | Weekly SBMs | within 9 months |
|
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Median Monthly Score on a 5-point Straining Scale Associated With Observed SBMs | Straining during observed SBMs is rated on a 5-point scale where 1=no straining and 5=extreme straining. A higher value is worse. | mITT with evaluable data at the given time point | Posted | Median | Full Range | score on a scale | within 9 months |
|
| ||||||||||||||||||||||||||||
| Other Pre-specified | Median Monthly Score on a Stool Consistency Scale Associated With Observed SBMs | Stool consistency is rated on a 5-Point Stool Consistency Scale, where 1=normal and 5=very hard. Higher scores mean a worse outcome. | mITT with evaluable data at the given time point | Posted | Median | Full Range | score on a scale | within 9 months |
|
| ||||||||||||||||||||||||||||
| Other Pre-specified | Median Monthly Score on a 4-point Pain Scale for Observed Abdominal Pain | Abdominal pain was rated on a scale from 1 (no pain) to 4 (very severe pain). A higher score means a worse outcome. | mITT with evaluable data at the given time point | Posted | Median | Full Range | score on a scale | within 9 months |
|
|
from first open-label dose to last open-label dose plus 7 days (9 months, 7 days)
Only treatment-emergent adverse events (AEs) are reported. Adverse events with onset dates after the administration of the first open-label dose and prior to the last open-label dose plus 7 days are considered treatment-emergent.
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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 | All Participants | Participants receive lubiprostone | 0 | 419 | 13 | 419 | 147 | 419 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tonsillar haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Conversion disorder | Psychiatric disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Depressed level of consciousness | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Faecaloma | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Faecal incontinence | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Gastrointestinal obstruction | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Hepatotoxicity | Hepatobiliary disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Team Leader | Mallinckrodt Pharmaceuticals | 800-556-3314 | clinicaltrials@mnk.com |
| Dec 13, 2019 |
| Prot_SAP_000.pdf |
| 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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