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Safety and Efficacy Study of Teduglutide in Subjects with Short Bowel Syndrome Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Safety and Efficacy Study of Teduglutide in Subjects with Short Bowel Syndrome conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Safety and Efficacy Study of Teduglutide in Subjects with Short Bowel Syndrome Clinical research trials and Safety and Efficacy Study of Teduglutide in Subjects with Short Bowel Syndrome healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Safety and Efficacy Study of Teduglutide in Subjects with Short Bowel Syndrome. Safety and Efficacy Study of Teduglutide in Subjects with Short Bowel Syndrome Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Safety and Efficacy Study of Teduglutide in Subjects with Short Bowel Syndrome clinical trial. Participants typically obtain the most effective healthcare available for their Safety and Efficacy Study of Teduglutide in Subjects with Short Bowel Syndrome condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Safety and Efficacy Study of Teduglutide in Subjects with Short Bowel Syndrome  Safety and Efficacy Study of Teduglutide in Subjects with Short Bowel Syndrome
Safety and Efficacy Study of Teduglutide in Subjects with Short Bowel Syndrome
For Condition: Parenteral Nutrition,Short Bowel Syndrome
Status: Recruiting
Sponsor(s): NPS Allelix Corp. ,
Synopsis: The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of teduglutide compared with placebo in subjects with parenteral nutrition (PN)-dependent short bowel syndrome (SBS).
Details: Teduglutide is an analog of glucagon-like peptide 2 (GLP-2), a naturally occurring hormone that regulates the growth, proliferation, and maintenance of cells lining the gastrointestinal tract. Teduglutide has been shown in animal studies and previous human clinical trials to increase the size and number of these cells, thereby increasing the absorptive surface area of the intestines. The multicenter, double-blind, international Phase III trial will randomly assign approximately 80 patients to receive daily subcutaneous injections of 0.05 milligrams or 0.10 milligrams of teduglutide per kilogram of body weight, or a placebo. Dosing will continue for a period of six months. The primary endpoint in the study is a reduction in the use of intravenous feeding, which is often required to sustain life in patients with SBS.
Eligibility:
Study Type: Interventional,燭reatment,燫andomized,燚ouble-Blind,燩lacebo Control,燩arallel Assignment,燬afety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Men and women, aged 18 years of age or older at the time of signing the informed consent form (ICF) - SBS as a result of major intestinal resection resulting in at least 12 months intravenous feeding - Body weight must be less than 90 kg - At baseline, subjects must require PN treatment to meet their caloric or electrolyte needs due to ongoing malabsorption at least 3 times weekly and to be on a stable PN regimen for 4 weeks before dosing - Body mass index (BMI) 18 to 27 kg/m2 - Adequate hepatic and renal function Exclusion Criteria: - History of cancer or clinically significant lymphoproliferative disease with fewer than 5 years documented disease-free state - History of alcohol or drug abuse (within previous year) - Participation in a clinical study within 30 days prior to signing the ICF, or concurrent participation in any clinical study - Clinically significant laboratory abnormalities at the time of randomization - Previous use of teduglutide (ALX-0600) - Prior use of native GLP-2 within 3 months of screening visit - Hospital admission within 1 month prior to screening visit - Pregnant or lactating women - Any condition or circumstance, which in the investigator鈥檚 opinion would put the subject at any undue risk, prevent completion of the study, or interfere with analysis of the study results. - Presence of excluded disease: Radiation enteritis, Scleroderma, Celiac disease, Refractory/Tropical sprue, Pseudo-obstruction, Active inflammatory bowel disease (IBD), Pre-malignant/malignant change in colonoscopy biopsy or polypectomy, Surgery scheduled within the time frame of the study, Human immunodeficiency virus (HIV) positive test, Immunological disorders, Possible allergies to teduglutide or its constituents, Significant, active, uncontrolled, untreated systemic diseases
Total Enrollment: 125
Location and Contact Information:
University of Nebraska Medical Center *Recruiting*
Omaha, Nebraska, 68198
United States
Recruiting Irene Akromis 402-559-8528
Charit茅 University Hospital *Not yet recruiting*
Berlin, , 10117
Germany
Not yet recruiting Wulf Breuel 49.30.450.522.033
H么pital Claude-Huriez *Not yet recruiting*
Lille, , 59037
France
Not yet recruiting David Seguy 33.3.20.44.53.43
University of Pennsylvania - Penn Nursing *Not yet recruiting*
Philadelphia, Pennsylvania, 19104
United States
Not yet recruiting Charlene Compher 215-898-3619
Vanderbilt Center for Human Nutrition *Recruiting*
Nashville, Tennessee, 37212
United States
Recruiting Alice Buchanan 615-936-1288
H么pital de la Croix-Rousse *Not yet recruiting*
Lyon, , 69317
France
Not yet recruiting Mich猫le G茅rard-Boncompain 33.4.72.07.17.62
St. Mark's Hospital *Recruiting*
Harrow, , HA13UJ
United Kingdom
Recruiting Katharina Wallis 44.208.235.4016
St. Michael's Hospital *Not yet recruiting*
Toronto, Ontario, M5B1W8
Canada
Not yet recruiting Tracey Pignatiello 416-864-5388
H么pital Lariboisi猫re *Not yet recruiting*
Paris, , 75475
France
Not yet recruiting Bernard Messing 33.1.49.95.25.78
Samodzielny Publiczny Szpital Kliniczny-Im.prof W.Or艂owskiego CMKP *Not yet recruiting*
Warsaw, , 00-416
Poland
Not yet recruiting Krystyna Majewska 48.22.622.76.18
Northwestern Center for Clinical Research *Not yet recruiting*
Chicago, Illinois, 60611
United States
Not yet recruiting Anita Wallin 312-695-4015
Albany Medical Center *Recruiting*
Albany, New York, 12208
United States
Recruiting Sandra Preston 518-262-6330
Emory University Hospital *Not yet recruiting*
Atlanta, Georgia, 30322
United States
Not yet recruiting Sharon Behan 404-727-3534
University of Kansas Medical Center *Recruiting*
Kansas City, Kansas, 66160
United States
Recruiting Marilyn Weckbaugh 913-588-1315
Academic Medical Center *Not yet recruiting*
Amsterdam, , 1100 DD
Netherlands
Not yet recruiting Mireille Serlie 31.20.566.6071
l'H么pital Erasme *Not yet recruiting*
Brussels, , 1070
Belgium
Not yet recruiting Nathalie Severs 32.2.555.44.55
St. Paul's Hospital *Not yet recruiting*
Vancouver, British Columbia, V6Z1Y6
Canada
Not yet recruiting Sarah Patterson 604-682-2344
Georgetown University *Not yet recruiting*
Washington D.C., District of Columbia, 20007
United States
Not yet recruiting Leslie Broseker 202-444-7397
The Cleveland Clinic Foundation *Not yet recruiting*
Cleveland, Ohio, 44195
United States
Not yet recruiting Amy Knesebeck 216-444-8539
Rigshospitalet, University of Copenhagen *Not yet recruiting*
Copenhagen, , 2100
Denmark
Not yet recruiting Palle Jeppensen 45.35.45.21.52
H么pital Edouard Herriot *Not yet recruiting*
Lyon, , 69437
France
Not yet recruiting C茅cile Chambrier 33.(0)4.72.11.76.13
Hope Hospital *Recruiting*
Salford, Greater Manchester, M68HD
United Kingdom
Recruiting Kay Davis 44.161.206.5148
University of Pittsburgh Medical Center *Not yet recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Not yet recruiting Brenda Owens 412-648-9449
Rhode Island Hospital *Not yet recruiting*
Providence, Rhode Island, 02903
United States
Not yet recruiting Marion Winkler 401-444-4296
Royal Alexandra Hospital *Not yet recruiting*
Edmonton, Alberta, T5H4B9
Canada
Not yet recruiting Daphne Meyer 780-429-3050
Toronto General Hospital *Not yet recruiting*
Toronto, Ontario, M5G2C4
Canada
Not yet recruiting Olivia Saqui 416-340-4018
University of Rochester Medical Center *Recruiting*
Rochester, New York, 14642
United States
Recruiting Christine Colombo 585-275-0803
Additional Information:
Study ID Numbers: CL0600-004;
Study Start Date: April 2004
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00081458
Other Short Bowel Syndrome Studies:
1. Safety and Efficacy Study of Teduglutide in Subjects with Short Bowel Syndrome
Related Studies:
Other Short Bowel Syndrome Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
Safety and Efficacy Study of Teduglutide in Subjects with Short Bowel Syndrome
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