Study of Teduglutide Effectiveness in Parenteral Nutrition (PN)-Dependent Short Bowel Syndrome (SBS) Subjects - Full Text View

Sponsors and Collaborators:	NPS Pharmaceuticals Nycomed
Information provided by:	NPS Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00798967

Purpose

Some people with SBS need to infuse parenteral nutrition (PN) in order to live. Although PN can save lives, it can lead to some serious side effects such as infection or liver damage. The risk for those effects increases the longer people are on PN.

Teduglutide is an investigative medicine being evaluated as a possible treatment for people with PN-dependent 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. We want to see if teduglutide can help decrease the amount of PN needed because the body is doing a better job of taking up what it eats and drinks. We also want to find out how safe teduglutide is and record any side effects.

Condition	Intervention	Phase
Short Bowel Syndrome Parenteral Nutrition	Drug: teduglutide Drug: placebo	Phase III

Drug Information available for: Teduglutide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A 24-Week Study of the Efficacy and Safety of Teduglutide in Subjects With Parenteral Nutrition-Dependent Short Bowel Syndrome

Further study details as provided by NPS Pharmaceuticals:

Primary Outcome Measures:

Percentage who demonstrate a response at Week 20 and maintain that response through Week 24. A response is at least a 20% reduction from baseline in weekly PN volume. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The secondary efficacy variables are based on reductions in PN/IV volume or the direct effects of improved intestinal absorption of fluid. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	86
Study Start Date:	November 2008
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 0.05 mg/kg/day teduglutide	Drug: teduglutide 0.05 mg/kg/day sc injection for 24 weeks
2: Placebo Comparator	Drug: placebo daily sc injection for 24 weeks

Detailed Description:

The study objective is to evaluate the efficacy, safety, and tolerability of teduglutide, an analog of native peptide GLP-2, as compared with placebo in subjects with parenteral nutrition (PN)-dependent short bowel syndrome (SBS). SBS results from inadequate length of residual intestine following surgical resection. As a consequence of the resection, there is a significant reduction in the bowel's absorptive capacity. A large proportion of SBS patients require the use of PN to supplement and stabilize their nutritional needs. Although PN is vital for those patients, its use is associated with high cost and potential life threatening complications, including sepsis and liver damage, whose risks increase the longer on PN. Consequently, increasing the absorptive capacity of the remaining intestine in order to decrease or remove SBS patients' dependence on PN is a rational therapeutic goal.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Short Bowel Syndrome
At least 12 months of continuous PN dependency
12 weeks of clinical remission of Crohn's disease (CD) prior to dosing
PN required at least 3 times weekly
A stable PN volume for four weeks prior to dosing

Exclusion Criteria:

History of cancer or clinically significant lymphoproliferative disease with fewer than 5 years documented disease-free state
Participation in clinical study within 30 days for drug or 90 days for antibody
Use of native GLP-2 or human growth hormone (HGH) within 6 months of screening
Use of iv glutamine within 6 months of screening
Use of teduglutide
CD patients who have been treated with biological therapy within 6 months of screening
IBD patients who require chronic systemic immunosuppressant therapy
More than 4 SBS- or PN-related hospitalizations within 12 months of screening
Unplanned hospitalization within one month of screening
Pregnant or lactating women
Body weight > 88kg
Body mass index (BMI) < 15 kg/m2
Severe hepatic impairment or disturbed renal function
Significant active, uncontrolled, untreated systemic diseases

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00798967

Contacts

Contact: Nancy McGraw

908-450-5300

nmcgraw@npsp.com

Locations

United States, Pennsylvania
University of Pennslyvania	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Charlene Compher, PhD, RD

Sponsors and Collaborators

NPS Pharmaceuticals

Nycomed

Investigators

Study Director:

Bo Joelsson, MD, PhD

NPS Pharmaceuticals

More Information

HPN support This link exits the ClinicalTrials.gov site

Responsible Party:	NPS Pharmaceuticals ( Bo Joelsson, MD, PhD / Head, Clinical Research )
Study ID Numbers:	CL0600-020
Study First Received:	November 25, 2008
Last Updated:	November 26, 2008
ClinicalTrials.gov Identifier:	NCT00798967
Health Authority:	United States: Food and Drug Administration

Keywords provided by NPS Pharmaceuticals:

SBS
short bowel syndrome
TPN
parenteral nutrition
PN

Study placed in the following topic categories:

Digestive System Diseases
Postoperative Complications
Gastrointestinal Diseases

Malabsorption Syndromes
Short Bowel Syndrome
Intestinal Diseases

Additional relevant MeSH terms:

Disease
Pathologic Processes
Syndrome

ClinicalTrials.gov processed this record on January 16, 2009