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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-006193-15 | EudraCT Number |
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| Name | Class |
|---|---|
| Nycomed | INDUSTRY |
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Teduglutide is an investigative medicine being evaluated as a possible treatment for people with parenteral nutrition (PN) dependent Short Bowel Syndrome (SBS). Teduglutide is similar to a protein the body makes. When people have SBS, their bodies do not make enough of the protein and they have trouble getting nutrients and fluids from the food they eat and drink. This study was designed to provide evidence of efficacy, safety, and tolerability of teduglutide 0.05 mg/kg daily in SBS subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teduglutide | Experimental | 0.05 mg/kg/day sc dose of teduglutide |
|
| Placebo | Placebo Comparator | Matching subcutaneous dose of placebo to teduglutide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| teduglutide | Drug | 0.05 mg/kg/day sc injection for 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Responder | Comparison of subjects treated with teduglutide to placebo who achieve a 20 to 100% reduction from baseline in weekly parenteral nutrition/intravenous fluid (PN/I.V.) volume at weeks 20 and 24. | Weeks 20 and 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change in PN/I.V. Volume From Baseline to Last Time Point | Absolute change in the volume of PN/I.V. from baseline (Week 0) to the visit when the last data point was collected (week 4 through week 24, or earlier if the subject discontinued early). | Week 0 to last visit when data was collected. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Clinic & Research Foundation | La Jolla | California | 92037 | United States | ||
| Washington Hospital Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16099790 | Result | Jeppesen PB, Sanguinetti EL, Buchman A, Howard L, Scolapio JS, Ziegler TR, Gregory J, Tappenden KA, Holst J, Mortensen PB. Teduglutide (ALX-0600), a dipeptidyl peptidase IV resistant glucagon-like peptide 2 analogue, improves intestinal function in short bowel syndrome patients. Gut. 2005 Sep;54(9):1224-31. doi: 10.1136/gut.2004.061440. | |
| 31784300 |
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Stage 1 was screening, optimization, and stabilization periods. At screening, if the PN/I.V. volume is not stable per protocol, s/he entered an optimization period (up to 8 weeks) to find the minimally tolerated stable volume of PN/I.V.. Prior to randomization, all entered 4-8 weeks of stabilization period on that volume of PN/I.V.
First Patient Screened - November 25, 2008; Last Patient Screened - July 13, 2010; First Patient Randomized - March 3, 2009; Last Patient Randomized - July 22, 2010; Locations - hospitals and transplant centers; Subjects must be on parenteral nutrition (PN) and/or intravenous (I.V.) fluids.
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| ID | Title | Description |
|---|---|---|
| FG000 | Teduglutide | 0.05 mg/kg/day subcutaneous (sc) dose of teduglutide |
| FG001 | Placebo | Matching sc dose of placebo to teduglutide |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| placebo | Drug | Matching daily subcutaneous dose of placebo to teduglutide for 24 weeks |
|
| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32224 | United States |
| Emory University School of Medicine | Atlanta | Georgia | 30322 | United States |
| Kansas University Medical Center | Kansas City | Kansas | 66160 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| University of Pennslyvania | Philadelphia | Pennsylvania | 19104 | United States |
| University Of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Critical Care Research, Royal Alexandra Hospital | Edmonton | Alberta | T5H 3V9 | Canada |
| Hamilton Health Sciences Centre | Hamilton | Ontario | L8N 3Z5 | Canada |
| Polyclinic Family and Specialty Medicine Facility | North York | Ontario | M3H 5S4 | Canada |
| University Health Network - Toronto General Hospital | Toronto | Ontario | M5G 2N2 | Canada |
| Rigshospitalet - Abdominalcentret, Hepatologisk Kilinik A | Copenhagen | 2100 | Denmark |
| Hôpital Beaujon | Clichy | 92110 | France |
| Hôpital Croix Rousse Unité de Nutrition Clinique Intensive | Lyon | France |
| Hôpital de l'Archet Pôle Digestif | Nice | 06100 | France |
| Universitaetsklinikum Tuebingen | Tübingen | Baden-Wurttemberg | 72076 | Germany |
| Israelitisches Krankenhaus | Hamburg | Free and Hanseatic City of Hamburg | 22297 | Germany |
| Med. Klinik m.S. Hepatologie und Gastroenterologie | Berlin | State of Berlin | 13353 | Germany |
| Azienda Ospedaliera Universitaria S. Giovanni Battista - Le Molinette | Torino | TO | 10126 | Italy |
| Policlinico Sant'Orsola - Malpighi centro insufficienza intestinale | Bologna | 40138 | Italy |
| Azienda Universitaria Policlinico Federico II | Naples | 80131 | Italy |
| Universitair Medisch Centrum St. Radboud | Nijmegen | 6525 GA | Netherlands |
| Wojewodzki Szpital Specjalistyczny im. M. Pirogowa, Pracownia Leczenia Zywieniowego | Lodz | 90-531 | Poland |
| Samodzielny Publiczny Szpital Kliniczny nr 4, Klinika Chirurgii Ogolnej i Transplantacyjnej | Lublin | 20-954 | Poland |
| Wojewodzki Szpital Specjalistyczny, | Olsztyn | 10-561 | Poland |
| Samodzielny Publiczny Szpital Kliniczny im. prof W. Orlowskiego CMKP, Oddzial Kliniczny Zywienia i Chirurgii | Warsaw | 00-416 | Poland |
| Hospital Universitario de Bellvitge | Barcelona | 08907 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| St. Mark's Hospital Northwick Park | Harrow | GT LON | HA1 3UJ | United Kingdom |
| University College Hospital | London | GT LON | NW1 2BU | United Kingdom |
| Green Area, Main Hospital Salford Royal Hospitals NHS Foundation Trust | Manchester | GT MAN | M6 8HD | United Kingdom |
| Jeppesen PB, Gabe SM, Seidner DL, Lee HM, Olivier C. Citrulline correlations in short bowel syndrome-intestinal failure by patient stratification: Analysis of 24 weeks of teduglutide treatment from a randomized controlled study. Clin Nutr. 2020 Aug;39(8):2479-2486. doi: 10.1016/j.clnu.2019.11.001. Epub 2019 Nov 9. |
| 29174926 | Derived | Jeppesen PB, Gabe SM, Seidner DL, Lee HM, Olivier C. Factors Associated With Response to Teduglutide in Patients With Short-Bowel Syndrome and Intestinal Failure. Gastroenterology. 2018 Mar;154(4):874-885. doi: 10.1053/j.gastro.2017.11.023. Epub 2017 Nov 22. |
| 27507402 | Derived | Fujioka K, Jeejeebhoy K, Pape UF, Li B, Youssef NN, Schneider SM. Patients With Short Bowel on Narcotics During 2 Randomized Trials Have Abdominal Complaints Independent of Teduglutide. JPEN J Parenter Enteral Nutr. 2017 Nov;41(8):1419-1422. doi: 10.1177/0148607116663481. Epub 2016 Aug 9. |
| 24134154 | Derived | Vipperla K, O'Keefe SJ. Study of teduglutide effectiveness in parenteral nutrition-dependent short-bowel syndrome subjects. Expert Rev Gastroenterol Hepatol. 2013 Nov;7(8):683-7. doi: 10.1586/17474124.2013.842894. Epub 2013 Oct 17. |
| 23587733 | Derived | Jeppesen PB, Pertkiewicz M, Forbes A, Pironi L, Gabe SM, Joly F, Messing B, Loth S, Youssef NN, Heinze H, Berghofer P. Quality of life in patients with short bowel syndrome treated with the new glucagon-like peptide-2 analogue teduglutide--analyses from a randomised, placebo-controlled study. Clin Nutr. 2013 Oct;32(5):713-21. doi: 10.1016/j.clnu.2013.03.016. Epub 2013 Mar 28. |
| 23274148 | Derived | Berghofer P, Fragkos KC, Baxter JP, Forbes A, Joly F, Heinze H, Loth S, Pertkiewicz M, Messing B, Jeppesen PB. Development and validation of the disease-specific Short Bowel Syndrome-Quality of Life (SBS-QoL) scale. Clin Nutr. 2013 Oct;32(5):789-96. doi: 10.1016/j.clnu.2012.12.001. Epub 2012 Dec 12. |
| 22982184 | Derived | Jeppesen PB, Pertkiewicz M, Messing B, Iyer K, Seidner DL, O'keefe SJ, Forbes A, Heinze H, Joelsson B. Teduglutide reduces need for parenteral support among patients with short bowel syndrome with intestinal failure. Gastroenterology. 2012 Dec;143(6):1473-1481.e3. doi: 10.1053/j.gastro.2012.09.007. Epub 2012 Sep 11. |
| Discontinued During Dosing Period |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Teduglutide | 0.05 mg/kg/day subcutaneous (sc) dose of teduglutide |
| BG001 | Placebo | Matching sc dose of placebo to teduglutide |
| BG002 | Total | Total of all reporting groups |
| 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 |
| |||||||||||||||
| Sex: Female, Male | 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 | Responder | Comparison of subjects treated with teduglutide to placebo who achieve a 20 to 100% reduction from baseline in weekly parenteral nutrition/intravenous fluid (PN/I.V.) volume at weeks 20 and 24. | Percentages were based on the number of subjects in the Intent to Treat (ITT) population. | Posted | Number | subjects | Weeks 20 and 24 |
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| Secondary | Absolute Change in PN/I.V. Volume From Baseline to Last Time Point | Absolute change in the volume of PN/I.V. from baseline (Week 0) to the visit when the last data point was collected (week 4 through week 24, or earlier if the subject discontinued early). | Intent-to-Treat (ITT) was defined for efficacy analyses which included all randomized patients. | Posted | Mean | Standard Deviation | Liters/Week | Week 0 to last visit when data was collected. |
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Adverse event data were collected for each subject from the time informed consent was signed to end of study. For this reporting of adverse event, the most commonly reported treatment emergent adverse events (>=3 subjects at SOC level) are listed.
All adverse experience reporting used the Safety population which consisted of 85 subjects who received at least one dose of study drug. There were 42 subjects treated with teduglutide, whereas 43 subjects received placebo. Adverse experience monitoring was performed through investigator assessment and safety laboratory testing at every visit.
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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 | Teduglutide | 0.05 mg/kg/day subcutaneous (sc) dose of teduglutide | 15 | 42 | 35 | 42 | ||
| EG001 | Placebo | Matching sc dose of placebo to teduglutide | 12 | 43 | 34 | 43 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adenovirus infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Bacteremia | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Catheter sepsis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Catheter-related complication | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Catheter-related infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Central line infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Device breakage | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Device dislocation | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Device failure | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Device malfunction | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Hepatitis cholestatic | Hepatobiliary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Implant site extravasation | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Infective thrombosis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Pneumonia influenzal | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Rectal abscess | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Small intestinal stenosis | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Subclavian vein thrombosis | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
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| Suicide attempt | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Central line systemic infections | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Edema peripheral | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Gastrointestinal stoma complication | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Weight increased | Investigations | MedDRA (12.0) | Systematic Assessment |
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The terms and conditions of NPS Pharmaceuticals agreements with its investigators may vary. However, NPS does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
| ID | Term |
|---|---|
| D012778 | Short Bowel Syndrome |
| D006963 | Hyperphagia |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C494910 | teduglutide |
| C438272 | ALX-0600 |
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| Male |
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