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Trial record 1 of 2 for:    9352883 [PUBMED-IDS]
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Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome

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ClinicalTrials.gov Identifier: NCT00081458
Recruitment Status : Completed
First Posted : April 14, 2004
Results First Posted : July 15, 2013
Last Update Posted : December 8, 2015
Sponsor:
Information provided by (Responsible Party):
Shire

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Short Bowel Syndrome
Interventions: Drug: Placebo
Drug: Teduglutide 0.05 mg/kg/d
Drug: Teduglutide 0.1 mg/kg/d

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First subject was screened 25May2004 and last subject evaluations were completed on 06Jul2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients underwent stabilization period for parenteral nutrition prior to randomization

Reporting Groups
  Description
Placebo Placebo injected subcutaneously daily
Teduglutide 0.05 mg/kg/d teduglutide 0.05 mg/kg/d injected subcutaneously
Teduglutide 0.1 mg/kg/d teduglutide 0.1 mg/kg/d injected subcutaneously

Participant Flow:   Overall Study
    Placebo   Teduglutide 0.05 mg/kg/d   Teduglutide 0.1 mg/kg/d
STARTED   16   35   33 
Received Treatment   16   35   32 [1] 
COMPLETED   15   27   29 
NOT COMPLETED   1   8   4 
Adverse Event                1                5                2 
Withdrawal by Subject                0                3                1 
Randomized but not dosed                0                0                1 
[1] 1 subject was randomized but did not receive the study drug



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
84 subjects were initially randomized; however, one subject never received study therapy. As a result, the total participant who started flow period is 83.

Reporting Groups
  Description
Placebo Placebo injected subcutaneously daily
Teduglutide 0.05 mg/kg/d teduglutide 0.05 mg/kg/d injected subcutaneously
Teduglutide 0.1 mg/kg/d teduglutide 0.1 mg/kg/d injected subcutaneously
Total Total of all reporting groups

Baseline Measures
   Placebo   Teduglutide 0.05 mg/kg/d   Teduglutide 0.1 mg/kg/d   Total 
Overall Participants Analyzed 
[Units: Participants]
 16   35   32   83 
Age 
[Units: Years]
Mean (Standard Deviation)
 49.4  (15.1)   47.1  (14.2)   50.3  (14.0)   48.8  (14.2) 
Age, Customized 
[Units: Participants]
       
< 35 years   3   7   5   15 
35-44 years   2   5   4   11 
45 - 54 years   3   12   10   25 
> 55 years   8   11   13   32 
Gender 
[Units: Participants]
       
Female   9   18   19   46 
Male   7   17   13   37 
Region of Enrollment 
[Units: Participants]
       
Belgium   1   1   0   2 
Canada   1   2   5   8 
Denmark   2   3   3   8 
France   2   5   2   9 
Germany   0   0   2   2 
Netherlands   0   4   1   5 
Poland   3   6   8   17 
United Kingdom   0   3   1   4 
United States   7   11   10   28 


  Outcome Measures

1.  Primary:   A Graded Response Score in Parenteral Nutrition (PN) Reduction   [ Time Frame: 6 months ]

2.  Secondary:   Number of Subjects Achieving Binary Response at Week 20, Maintained at Week 24   [ Time Frame: 6 months of treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Head of Clinical Research
Organization: NPS Pharmaceuticals
phone: 908-450-5300
e-mail: info@npsp.com


Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00081458     History of Changes
Other Study ID Numbers: CL0600-004
First Submitted: April 13, 2004
First Posted: April 14, 2004
Results First Submitted: September 24, 2010
Results First Posted: July 15, 2013
Last Update Posted: December 8, 2015