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28 Day Repeat Dose in Cystic Fibrosis Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00903201
First Posted: May 18, 2009
Last Update Posted: November 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
Results First Submitted: August 31, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Cystic Fibrosis
Interventions: Drug: SB656933
Drug: Placebo

  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
This study was conducted at 16 centers in the United States of America, 6 centers in Germany, 5 centers in France, 3 centers in Israel and 1 center in Canada from 28 September 2009 to 29 December 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were screened for a period of 28 days and at that time their eligibility for study inclusion was assessed. A total of 146 participants with cystic fibrosis were randomized to receive either 20 mg, 50 mg SB656933 or placebo orally for 28 days.

Reporting Groups
  Description
Placebo Eligible participants received SB656933 matching placebo tablets via oral route, two tablets each morning, for a total of 28 days.
SB656933 20 mg Eligible participants received SB656933 20 milligrams (mg) tablets (two tablets of 10 mg each, every morning) via oral route, for a total of 28 days.
SB656933 50 mg Eligible participants received two tablets (one tablet of SB656933 50 mg and one SB656933 matching placebo tablet) each morning, via oral route, for a total of 28 days.

Participant Flow:   Overall Study
    Placebo   SB656933 20 mg   SB656933 50 mg
STARTED   61   44   41 
COMPLETED   56   38   39 
NOT COMPLETED   5   6   2 
Adverse Event                1                4                0 
Protocol Violation                2                1                0 
Lost to Follow-up                0                1                0 
Physician Decision                1                0                1 
Withdrawal by Subject                1                0                1 



  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 Eligible participants received SB656933 matching placebo tablets via oral route, two tablets each morning, for a total of 28 days.
SB656933 20 mg Eligible participants received SB656933 20 mg tablets (two tablets of 10 mg each, every morning) via oral route, for a total of 28 days.
SB656933 50 mg Eligible participants received two tablets (one tablet of SB656933 50 mg and one SB656933 matching placebo tablet) each morning, via oral route, for a total of 28 days.
Total Total of all reporting groups

Baseline Measures
   Placebo   SB656933 20 mg   SB656933 50 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 61   44   41   146 
Age 
[Units: Years]
Mean (Standard Deviation)
 29.5  (8.41)   32.9  (11.65)   31.3  (12.12)   31.0  (10.59) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      22  36.1%      16  36.4%      17  41.5%      55  37.7% 
Male      39  63.9%      28  63.6%      24  58.5%      91  62.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      2   3.3%      0   0.0%      0   0.0%      2   1.4% 
White      59  96.7%      43  97.7%      41 100.0%      143  97.9% 
More than one race      0   0.0%      1   2.3%      0   0.0%      1   0.7% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)   [ Time Frame: Up to Follow-up (up to 42 days) ]

2.  Primary:   Number of Participants With Vital Signs of Potential Clinical Importance   [ Time Frame: Up to Follow-up (up to 42 days) ]

3.  Primary:   Number of Participants With Hematology Abnormalities of Potential Clinical Importance   [ Time Frame: Up to Follow-up (up to 42 days) ]

4.  Primary:   Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance   [ Time Frame: Up to Follow-up (up to 42 days) ]

5.  Primary:   Number of Participants With Abnormal Electrocardiogram (ECG) Findings   [ Time Frame: Up to Follow-up (up to 42 days) ]

6.  Primary:   Number of Participants With Cystic Fibrosis (CF) Exacerbation   [ Time Frame: Day 1 to Day 42 ]

7.  Secondary:   Number of Participants With Pseudomonas Aeruginosa and Staphylococcus Aureus Count in Sputum   [ Time Frame: Day 1 and Day 28 ]

8.  Secondary:   Induced Sputum Neutrophil Number   [ Time Frame: Day 28 ]

9.  Secondary:   Induced Sputum Neutrophil Percentage   [ Time Frame: Day 28 ]

10.  Secondary:   Induced Sputum Inflammatory Markers-Myeloperoxidase and Neutrophil Elastase   [ Time Frame: Day 28 ]

11.  Secondary:   Serum and Plasma Markers of Inflammation- Clara Cell Secretory Protein (CC-16) and CXCL8 (Interleukin-8 [IL-8])   [ Time Frame: Day 14 and Day 28 ]

12.  Secondary:   Serum and Plasma Markers of Inflammation- C-reactive Protein (CRP)   [ Time Frame: Day 14 and Day 28 ]

13.  Secondary:   Serum and Plasma Markers of Inflammation- Fibrinogen   [ Time Frame: Day 14 and Day 28 ]

14.  Secondary:   Serum and Plasma Markers of Inflammation- Matrix Metalloproteinase-8 (MMP8), Matrix Metalloproteinase-9 (MMP9) and Surfactant Protein D (SP-D)   [ Time Frame: Day 14 and Day 28 ]

15.  Secondary:   Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC)   [ Time Frame: Baseline (Day 1) to Day 14 and Day 28 ]

16.  Secondary:   Area Under the Plasma Drug Concentration (AUC) Versus Time Curve: AUC From Time Zero (Pre-dose) to Four Hours Post Dose (AUC[0-4]) and AUC From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC[0-t])   [ Time Frame: Day 1: pre-dose, 0.5, 1, 2, 4 and 8 hours post-dose and Day 28: pre-dose, 1 and 4 hours ]

17.  Secondary:   Maximum Observed Plasma Drug Concentration (Cmax)   [ Time Frame: Day 1: pre-dose, 0.5, 1, 2, 4 and 8 hours post-dose and Day 28: pre-dose, 1 and 4 hours ]

18.  Secondary:   Time to Maximum Observed Plasma Drug Concentration (Tmax)   [ Time Frame: Day 1: pre-dose, 0.5, 1, 2, 4 and 8 hours post-dose and Day 28: pre-dose, 1 and 4 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  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 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: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00903201     History of Changes
Obsolete Identifiers: NCT01051453
Other Study ID Numbers: 110399
First Submitted: May 14, 2009
First Posted: May 18, 2009
Results First Submitted: August 31, 2017
Results First Posted: November 16, 2017
Last Update Posted: November 16, 2017