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Dose Response of 28 Days of Dosing of GSK962040 in Type I and II Diabetic Male and Female Subjects With Gastroparesis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01262898
First Posted: December 17, 2010
Last Update Posted: October 13, 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: September 14, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Gastroparesis
Interventions: Drug: GSK962040 (5 mg tablet)
Drug: GSK962040 (25 mg tablet)
Drug: GSK962040 (125 mg tablet)
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 80 participants were enrolled and randomized from 03 May 2011 to 26 Feb 2013. The study was conducted at 22 centers, 1 center in Australia, 1 center in Sweden, 2 centers in Belgium, 4 centers in Canada, 5 Centers in United Kingdom and 9 centers in United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Out of 80 participants randomized, 1 participant withdrew consent prior to dosing in GSK962040 50 milligram (mg) arm. Remaining 79 participants were included in "All subject population"

Reporting Groups
  Description
Placebo Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
GSK962040 10 mg Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
GSK962040 50 mg Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
GSK962040 125 mg Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.

Participant Flow:   Overall Study
    Placebo   GSK962040 10 mg   GSK962040 50 mg   GSK962040 125 mg
STARTED   21   18   18   22 
COMPLETED   18   16   18   22 
NOT COMPLETED   3   2   0   0 
Protocol Violation                1                1                0                0 
Lost to Follow-up                1                0                0                0 
Withdrawal by Subject                1                1                0                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 Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
GSK962040 10 mg Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
GSK962040 50 mg Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
GSK962040 125 mg Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
Total Total of all reporting groups

Baseline Measures
   Placebo   GSK962040 10 mg   GSK962040 50 mg   GSK962040 125 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 21   18   18   22   79 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.6  (14.23)   54.0  (11.42)   55.2  (12.17)   51.4  (11.34)   53.7  (12.22) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      14  66.7%      14  77.8%      10  55.6%      9  40.9%      47  59.5% 
Male      7  33.3%      4  22.2%      8  44.4%      13  59.1%      32  40.5% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
         
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      1   4.5%      1   1.3% 
Asian      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      1   5.6%      1   5.6%      1   4.5%      3   3.8% 
Black or African American      2   9.5%      2  11.1%      0   0.0%      0   0.0%      4   5.1% 
White      19  90.5%      15  83.3%      17  94.4%      20  90.9%      71  89.9% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Gastric Half Emptying Time (GEt1/2)   [ Time Frame: Screening2/Baseline (Day -30 to -1) , Day 1, and Day 28 ]

2.  Secondary:   Number of Participants With On-treatment Adverse Events (AES) and Serious Adverse Events(SAEs)   [ Time Frame: Up to follow-up (5-10 days post last dose) ]

3.  Secondary:   Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure(DBP) at Specified Time Points in Semi-supine Position   [ Time Frame: Baseline, Day 1, and Day 8 ]

4.  Secondary:   Change From Baseline in Heart Rate at Specified Time Points in Semi-supine Position   [ Time Frame: Baseline, Day 1, and Day 8 ]

5.  Secondary:   Change From Baseline in Electrocardiography Parameters (12-lead ECG)   [ Time Frame: Baseline, Day 1 and Day 28 ]

6.  Secondary:   Number of Participants Outside the Normal Range for SBP and DBP   [ Time Frame: Screening2/Baseline (Day -30 to -1), Day 1 and 28 ]

7.  Secondary:   Number of Participants Outside the Normal Range for Heart Rate   [ Time Frame: Screening2/Baseline (Day -30 to -1), Day 1 and 28 ]

8.  Secondary:   Number of Participants Outside the Normal Range for 12-lead ECG   [ Time Frame: Baseline (Day 1 pre-dose), Day 1, Day 14 and Day 28 ]

9.  Secondary:   Mean Change From Baseline in Clinical Chemistry: Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Gamma Glutamyl Transferase, Creatine Kinase, Lactate Dehydrogenase   [ Time Frame: Baseline (Day 1 pre-dose), Day 5, 10, 14, 21 and 28 ]

10.  Secondary:   Mean Change From Baseline in Clinical Chemistry: Direct Bilirubin, Total Bilirubin, Creatinine, Uric Acid   [ Time Frame: Baseline (Day 1 pre-dose), Day 5, 10, 14, 21 and 28 ]

11.  Secondary:   Mean Change From Baseline in Clinical Chemistry : Albumin, Total Protein   [ Time Frame: Baseline (Day 1 pre-dose) and Day 28 ]

12.  Secondary:   Mean Change From Baseline in Clinical Chemistry : Calcium, Chloride, Glucose, Potassium, Sodium, Urea/BUN, Carbon Dioxide Content/Bicarbonate   [ Time Frame: Baseline (Day 1 pre-dose) and Day 28 ]

13.  Secondary:   Mean Change From Baseline in Hematology Parameters : Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total ANC - Total Absolute Neutrophil Count), Platelet Count, White Blood Cell Count   [ Time Frame: Baseline (Day 1 pre-dose) and Day 28 ]

14.  Secondary:   Mean Change From Baseline in Hematology Parameters : Hematocrit   [ Time Frame: Baseline (Day 1 pre-dose) and Day 28 ]

15.  Secondary:   Mean Change From Baseline in Hematology Parameters : Mean Corpuscle Hemoglobin   [ Time Frame: Baseline (Day 1 pre-dose) and Day 28 ]

16.  Secondary:   Mean Change From Baseline in Hematology Parameters : Hemoglobin, Mean Corpuscle Hemoglobin Concentration   [ Time Frame: Baseline (Day 1 pre-dose) and Day 28 ]

17.  Secondary:   Mean Change From Baseline in Hematology Parameters : Mean Corpuscle Volume   [ Time Frame: Baseline (Day 1 pre-dose) and Day 28 ]

18.  Secondary:   Mean Change From Baseline in Hematology Parameters : Red Blood Cell Count, Reticulocytes   [ Time Frame: Baseline (Day 1 pre-dose) and Day 28 ]

19.  Secondary:   Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration AUC(0-t) at Specified Time Points   [ Time Frame: Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28 ]

20.  Secondary:   Maximum Observed Concentration (Cmax) at Specified Time Points   [ Time Frame: Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28 ]

21.  Secondary:   Time of Occurrence of Cmax (Tmax) at Specified Time Points   [ Time Frame: Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28 ]

22.  Secondary:   Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ct) at Specified Time Points   [ Time Frame: Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28 ]

23.  Secondary:   Apparent Clearance Following Oral Dosing (CL/F) at Specified Time Points   [ Time Frame: Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28 ]

24.  Secondary:   Apparent Volume of Distribution (V/F) at Specified Time Points   [ Time Frame: Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28 ]

25.  Secondary:   Apparent Terminal Elimination Half-life (t1/2) at Specified Time Points   [ Time Frame: Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28 ]

26.  Secondary:   Time to First Bowel Movement After First Dose   [ Time Frame: Up to Day 28 ]

27.  Secondary:   Daily Bowel Movement Frequency   [ Time Frame: Up to Week 4 (Day 28) ]

28.  Secondary:   Daily Average Stool Consistency   [ Time Frame: Up to Week 4 (Day 28) ]

29.  Secondary:   Change From Baseline in Upper Gastrointestinal (GI) Symptoms as Assessed by Total Gastrointestinal Cardinal Symptom Index – Daily Diary (GCSI–DD)   [ Time Frame: Up to 14 days post last dose (Day 28) ]

30.  Secondary:   Change From Baseline in Whole Bowel Transit Time, 100 % Gastric Emptying Time (Truncated at 240 Minutes), Small Bowel Transit Time, Colonic Transit Time as Determined by Wireless Motility Capsule (WMC)   [ Time Frame: Baseline(Screening i.e., Day -30 to -1), Day 1 and 28 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
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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



Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01262898     History of Changes
Other Study ID Numbers: 114479
First Submitted: December 16, 2010
First Posted: December 17, 2010
Results First Submitted: September 14, 2017
Results First Posted: October 13, 2017
Last Update Posted: October 13, 2017