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Study of LX1606 in Subjects With Symptomatic Carcinoid Syndrome

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ClinicalTrials.gov Identifier: NCT01104415
Recruitment Status : Completed
First Posted : April 15, 2010
Results First Posted : April 6, 2018
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Lexicon Pharmaceuticals

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Symptoms of Carcinoid Syndrome
Interventions: Drug: Low Dose LX1606 - Day 1 (start)
Drug: Mid-low dose LX1606 - Day 15 (start)
Drug: Mid-high dose LX1606 - Day 29 (start)
Drug: High dose LX1606 - Day 43 (start)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Up to 15 subjects were to be enrolled and treated in the open-label Core Phase in the United Kingdom and Germany. The recruitment period lasted approximately 18 months.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
LX1606 - Core Phase No text entered.

Participant Flow:   Overall Study
    LX1606 - Core Phase
STARTED   15 
COMPLETED   14 
NOT COMPLETED   1 
Withdrawal by Subject                1 



  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.
No text entered.

Reporting Groups
  Description
LX1606 - Core Phase No text entered.

Baseline Measures
   LX1606 - Core Phase 
Overall Participants Analyzed 
[Units: Participants]
 15 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.1  (9.35) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      7  46.7% 
Male      8  53.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      15 100.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United Kingdom   6 
Germany   9 


  Outcome Measures

1.  Primary:   Number of Patients With Any Drug-related Treatment-emergent Adverse Event   [ Time Frame: Baseline, up to 12 weeks ]

2.  Primary:   Number of Patients With Any Drug-related Treatment-emergent Adverse Event   [ Time Frame: 124 weeks ]

3.  Secondary:   Change in Number of Bowel Movements   [ Time Frame: Baseline up to Weeks 9-12 ]

4.  Secondary:   Change in Weekly Stool Form   [ Time Frame: Baseline up to Weeks 9-12 ]

5.  Secondary:   Change in Proportion of Days With Sensation of Urgency to Defecate   [ Time Frame: Baseline up to Weeks 9-12 ]

6.  Secondary:   Change in Sensation/Severity of Nausea   [ Time Frame: Baseline up to Weeks 9-12 ]

7.  Secondary:   Number of Patients With an Improvement in Global Assessment of Symptoms Associated With Carcinoid Syndrome   [ Time Frame: Weeks 9-12 ]

8.  Secondary:   Change in Daily Severity of Abdominal Pain or Discomfort   [ Time Frame: Baseline up to Weeks 9-12 ]

9.  Secondary:   Change in Daily Number of Cutaneous Flushing Episodes   [ Time Frame: Baseline up to Weeks 9-12 ]

10.  Secondary:   Change in Urinary 5-Hydroxyindoleacetic Acid (HIAA)   [ Time Frame: Week 12 ]

11.  Secondary:   Change in Weekly Bowel Movements   [ Time Frame: Baseline up to Week 24 ]

12.  Secondary:   Change in Weekly Stool Form   [ Time Frame: Baseline up to Week 24 ]

13.  Secondary:   Change From Baseline in Weekly Sensation of Urgency to Defecate   [ Time Frame: Baseline to Week 24 ]

14.  Secondary:   Change From Baseline in Weekly Sensation of Nausea   [ Time Frame: Baseline to Week 24 ]

15.  Secondary:   Number of Patients Reporting Adequate Relief   [ Time Frame: Week 24 ]

16.  Secondary:   Change From Baseline in Weekly Level of Abdominal Pain or Discomfort   [ Time Frame: Baseline to Week 24 ]

17.  Secondary:   Change in Number of Cutaneous Flushing Episodes   [ Time Frame: Baseline up to Week 24 ]

18.  Secondary:   Change in Urinary 5-Hydroxyindoleacetic Acid (HIAA)   [ Time Frame: Baseline to Week 20-21 ]


  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: Pablo Lapuerta, MD
Organization: Lexicon Pharmaceuticals, Inc.
e-mail: plapuerta@lexpharma.com


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

Responsible Party: Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01104415     History of Changes
Other Study ID Numbers: Protocol LX1606.1-203-CS
LX1606.203, LX1032 ( Other Identifier: Lexicon Pharmaceuticals, Inc. )
2013-002596-18 ( EudraCT Number )
First Submitted: April 12, 2010
First Posted: April 15, 2010
Results First Submitted: March 27, 2017
Results First Posted: April 6, 2018
Last Update Posted: April 6, 2018