Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NPS Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00172185
First received: September 13, 2005
Last updated: June 26, 2013
Last verified: June 2013
Results First Received: March 12, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Short Bowel Syndrome
Interventions: Drug: teduglutide 0.05 mg/kg/d
Drug: teduglutide 0.10 mg/kg/d

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
10Jan2005 - First Subject Enrolled 24Jan2008 - Last Subject Completed

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This was a 28-week study of the safety and efficacy of teduglutide in subjects with parenteral nutrition-dependent short bowel syndrome who completed protocol CL0600-004

Reporting Groups
  Description
Placebo/0.05 Received placebo in Study 004/ Received Teduglutide 0.05 mg/kg/d in Study 005
Placebo/0.10 Received placebo in Study 004/ Received Teduglutide 0.10 mg/kg/d in Study 005
0.05/0.05 Received Teduglutide 0.05 mg/kg/d in Study 004/ Received Teduglutide 0.05 mg/kg/d in Study 005
0.10/0.10 Received Teduglutide 0.10 mg/kg/d in Study 004/ Received Teduglutide 0.10 mg/kg/d in Study 005

Participant Flow:   Overall Study
    Placebo/0.05     Placebo/0.10     0.05/0.05     0.10/0.10  
STARTED     6     7     25     27  
COMPLETED     6     5     20     23  
NOT COMPLETED     0     2     5     4  
Adverse Event                 0                 1                 3                 4  
Physician Decision                 0                 0                 1                 0  
SPONSOR Decision                 0                 1                 0                 0  
Withdrawal by Subject                 0                 0                 1                 0  



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
Placebo/0.05 Received placebo in Study 004/ Received Teduglutide 0.05 mg/kg/d in Study 005
Placebo/0.10 Received placebo in Study 004/ Received Teduglutide 0.10 mg/kg/d in Study 005
0.05/0.05 Received Teduglutide 0.05 mg/kg/d in Study 004/ Received Teduglutide 0.05 mg/kg/d in Study 005
0.10/0.10 Received Teduglutide 0.10 mg/kg/d in Study 004/ Received Teduglutide 0.10 mg/kg/d in Study 005
Total Total of all reporting groups

Baseline Measures
    Placebo/0.05     Placebo/0.10     0.05/0.05     0.10/0.10     Total  
Number of Participants  
[units: participants]
  6     7     25     27     65  
Age  
[units: years]
Mean ± Standard Deviation
  42.2  ± 14.06     56.6  ± 9.74     46.7  ± 13.48     49.4  ± 14.04     48.5  ± 13.61  
Gender  
[units: participants]
         
Female     4     4     10     14     32  
Male     2     3     15     13     33  
Race (NIH/OMB)  
[units: Participants]
         
American Indian or Alaska Native     0     0     0     0     0  
Asian     0     0     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0     0     0  
Black or African American     1     0     3     2     6  
White     5     7     22     25     59  
More than one race     0     0     0     0     0  
Unknown or Not Reported     0     0     0     0     0  



  Outcome Measures
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1.  Primary:   Number of Subjects Achieving a 20% Reduction at Week 28   [ Time Frame: 28 weeks ]

2.  Secondary:   Number of Subjects Who Achieved at Least a One-Day Reduction in Parenteral Nutrition (PN) Use   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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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.


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.  


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


Publications of Results:
Publications automatically indexed to this study:

Responsible Party: NPS Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00172185     History of Changes
Other Study ID Numbers: CL0600-005
Study First Received: September 13, 2005
Results First Received: March 12, 2013
Last Updated: June 26, 2013
Health Authority: United States: Food and Drug Administration