Trial Outcomes & Findings for A Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects With Moderately-to-Severely Active Crohn's Disease (NCT NCT01277666)
NCT ID: NCT01277666
Last Updated: 2017-09-19
Results Overview
CDAI is a number which consists of information collected from a 7-day diary from the participants regarding symptoms. Remission is considered a score of 150 or less. Active disease is considered 200 or greater. A response to therapy is considered a decline in CDAI score of 70-points from baseline. The score was algorithmically derived from the sum of participant reported Crohn's disease symptoms recorded over 7 days and investigator recorded assessments of the participant's condition, laboratory parameters and use of anti-diarrhoeal medication. CDAI score was calculated based on the data collected in the diary card. The total CDAI score ranged from 0 to approximately 600, where higher scores indicate more severe disease. Both participants and investigators made their entries via IVRS each evening before going to bed. Percentage of participants with CDAI response at Week 12 was presented.
COMPLETED
PHASE3
608 participants
Week 12
2017-09-19
Participant Flow
A total of 608 participants with moderately-to-severely active Crohn's disease were enrolled in this study. The study was conducted at 162 centres in 23 countries, with sites in North America, Europe, Israel, South Africa, Japan, Australia, Korea and New Zealand. Study duration was from 20 December 2010 to 11 July 2013.
Of the total 1205 participants screened, 597 were screen failures and 608 participants were randomized in the study.
Participant milestones
| Measure |
Placebo
Eligible participants were randomized at baseline (Week 0) to receive matching placebo orally for 12 weeks treatment period
|
GSK1605786A 500 mg Once Daily
Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 milligram (mg) once daily hard gelatin capsules orally for 12 weeks treatment period
|
GSK1605786A 500 mg Twice Daily
Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg twice daily hard gelatin capsules orally for 12 weeks treatment period
|
|---|---|---|---|
|
Overall Study
STARTED
|
203
|
203
|
202
|
|
Overall Study
COMPLETED
|
158
|
144
|
153
|
|
Overall Study
NOT COMPLETED
|
45
|
59
|
49
|
Reasons for withdrawal
| Measure |
Placebo
Eligible participants were randomized at baseline (Week 0) to receive matching placebo orally for 12 weeks treatment period
|
GSK1605786A 500 mg Once Daily
Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 milligram (mg) once daily hard gelatin capsules orally for 12 weeks treatment period
|
GSK1605786A 500 mg Twice Daily
Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg twice daily hard gelatin capsules orally for 12 weeks treatment period
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
26
|
25
|
20
|
|
Overall Study
Lack of Efficacy
|
8
|
20
|
12
|
|
Overall Study
Protocol Violation
|
2
|
3
|
2
|
|
Overall Study
Protocol Defined Stopping criteria
|
1
|
2
|
6
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
7
|
8
|
6
|
|
Overall Study
Death
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects With Moderately-to-Severely Active Crohn's Disease
Baseline characteristics by cohort
| Measure |
Placebo
n=203 Participants
Eligible participants were randomized at baseline (Week 0) to receive matching placebo orally for 12 weeks treatment period.
|
GSK1605786A 500 mg Once Daily
n=203 Participants
Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg once daily hard gelatin capsules orally for 12 weeks treatment period.
|
GSK1605786A 500 mg Twice Daily
n=202 Participants
Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg twice daily hard gelatin capsules orally for 12 weeks treatment period.
|
Total
n=608 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
36.1 Years
STANDARD_DEVIATION 12.62 • n=5 Participants
|
37.0 Years
STANDARD_DEVIATION 12.60 • n=7 Participants
|
35.9 Years
STANDARD_DEVIATION 12.51 • n=5 Participants
|
36.3 Years
STANDARD_DEVIATION 12.56 • n=4 Participants
|
|
Sex: Female, Male
Female
|
103 Participants
n=5 Participants
|
130 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
339 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
100 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
269 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
18 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
177 Participants
n=5 Participants
|
177 Participants
n=7 Participants
|
179 Participants
n=5 Participants
|
533 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: The intent to treat population comprised of all participants randomized to double-blind treatment for 12 weeks.
CDAI is a number which consists of information collected from a 7-day diary from the participants regarding symptoms. Remission is considered a score of 150 or less. Active disease is considered 200 or greater. A response to therapy is considered a decline in CDAI score of 70-points from baseline. The score was algorithmically derived from the sum of participant reported Crohn's disease symptoms recorded over 7 days and investigator recorded assessments of the participant's condition, laboratory parameters and use of anti-diarrhoeal medication. CDAI score was calculated based on the data collected in the diary card. The total CDAI score ranged from 0 to approximately 600, where higher scores indicate more severe disease. Both participants and investigators made their entries via IVRS each evening before going to bed. Percentage of participants with CDAI response at Week 12 was presented.
Outcome measures
| Measure |
Placebo
n=203 Participants
Eligible participants were randomized at baseline (Week 0) to receive matching placebo orally for 12 weeks treatment period.
|
GSK1605786A 500 mg Once Daily
n=203 Participants
Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg once daily hard gelatin capsules orally for 12 weeks treatment period.
|
GSK1605786A 500 mg Twice Daily
n=202 Participants
Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg twice daily hard gelatin capsules orally for 12 weeks treatment period.
|
|---|---|---|---|
|
Percentage of Participants With Crohn's Disease Activity Index (CDAI) Response at Week 12
|
25.1 Percentage of participants
Interval 19.2 to 31.1
|
27.6 Percentage of participants
Interval 21.4 to 33.7
|
27.2 Percentage of participants
Interval 21.1 to 33.4
|
SECONDARY outcome
Timeframe: Week 12Population: Intent to treat population.
CDAI is a recognized scoring system to categorize disease severity with scores of \>= 220 to \<= 450 describing the moderately-to-severely active population. Clinical remission is defined as a CDAI score \< 150 points if baseline CDAI is \>= 150. If baseline CDAI is \<150, the participant was not considered in remission. Participants with missing CDAI scores were considered not in remission according to the missing=no effect imputation. Percentage of participants in clinical remission at Week 12 was presented.
Outcome measures
| Measure |
Placebo
n=203 Participants
Eligible participants were randomized at baseline (Week 0) to receive matching placebo orally for 12 weeks treatment period.
|
GSK1605786A 500 mg Once Daily
n=203 Participants
Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg once daily hard gelatin capsules orally for 12 weeks treatment period.
|
GSK1605786A 500 mg Twice Daily
n=202 Participants
Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg twice daily hard gelatin capsules orally for 12 weeks treatment period.
|
|---|---|---|---|
|
Percentage of Participants With CDAI Remission at Week 12
|
15.3 Percentage of participants
Interval 10.3 to 20.2
|
13.3 Percentage of participants
Interval 8.6 to 18.0
|
12.9 Percentage of participants
Interval 8.3 to 17.5
|
SECONDARY outcome
Timeframe: At Week 8 and 12Population: Intent to treat population
Responders were defined as participants with CDAI decrease from baseline of \>= 100 points. CDAI is a recognized scoring system to categorize disease severity with scores of \>= 220 to \<= 450 describing the moderately-to-severely active population. The score was algorithmically derived from the sum of participant reported Crohn's disease symptoms recorded over 7 days and investigator recorded assessments of the participant's condition, laboratory parameters and use of anti-diarrhoeal medication. Both participants and investigators made their entries via IVRS each evening before going to bed. Percentage of participants with CDAI decrease from baseline of \>=100 points was presented.
Outcome measures
| Measure |
Placebo
n=203 Participants
Eligible participants were randomized at baseline (Week 0) to receive matching placebo orally for 12 weeks treatment period.
|
GSK1605786A 500 mg Once Daily
n=203 Participants
Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg once daily hard gelatin capsules orally for 12 weeks treatment period.
|
GSK1605786A 500 mg Twice Daily
n=202 Participants
Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg twice daily hard gelatin capsules orally for 12 weeks treatment period.
|
|---|---|---|---|
|
Percentage of Participants With a Clinical Response (CDAI Decrease From Baseline of >= 100 Points) at Both Week 8 and Week 12
|
15.8 Percentage of participants
Interval 10.8 to 20.8
|
18.7 Percentage of participants
Interval 13.4 to 24.1
|
19.3 Percentage of participants
Interval 13.9 to 24.8
|
SECONDARY outcome
Timeframe: Week 8 and 12Population: Intent to treat population.
Clinical remission is defined as a CDAI score \< 150 points if baseline CDAI is \>= 150. If baseline CDAI is \<150, the participant was not considered in remission. participants with missing CDAI scores were considered not in remission according to the missing=no effect imputation. Percentage of participants in clinical remission defined as a CDAI score of less than 150 points at other time points was presented.
Outcome measures
| Measure |
Placebo
n=203 Participants
Eligible participants were randomized at baseline (Week 0) to receive matching placebo orally for 12 weeks treatment period.
|
GSK1605786A 500 mg Once Daily
n=203 Participants
Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg once daily hard gelatin capsules orally for 12 weeks treatment period.
|
GSK1605786A 500 mg Twice Daily
n=202 Participants
Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg twice daily hard gelatin capsules orally for 12 weeks treatment period.
|
|---|---|---|---|
|
Percentage of Participants Achieving Clinical Remission (CDAI <150 Points) at Both Week 8 and Week 12
|
7.9 Percentage of participants
Interval 4.2 to 11.6
|
7.9 Percentage of participants
Interval 4.2 to 11.6
|
6.9 Percentage of participants
Interval 3.4 to 10.4
|
SECONDARY outcome
Timeframe: Week 8Population: Intent to treat population.
CDAI is a recognized scoring system to categorize disease severity with scores of \>= 220 to \<= 450 describing the moderately-to-severely active population. The score was algorithmically derived from the sum of participant reported Crohn's disease symptoms recorded over 7 days and investigator recorded assessments of the participant's condition, laboratory parameters and use of anti-diarrhoeal medication. Both participants and investigators made their entries via IVRS each evening before going to bed. Percentage of Participants with a clinical response CDAI decrease from baseline of \>=100 points at Week 8 was presented.
Outcome measures
| Measure |
Placebo
n=203 Participants
Eligible participants were randomized at baseline (Week 0) to receive matching placebo orally for 12 weeks treatment period.
|
GSK1605786A 500 mg Once Daily
n=203 Participants
Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg once daily hard gelatin capsules orally for 12 weeks treatment period.
|
GSK1605786A 500 mg Twice Daily
n=202 Participants
Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg twice daily hard gelatin capsules orally for 12 weeks treatment period.
|
|---|---|---|---|
|
Percentage of Participants With a Clinical Response (CDAI Decrease From Baseline of >=100 Points) at Week 8
|
24.1 Percentage of Participants
Interval 18.3 to 30.0
|
26.1 Percentage of Participants
Interval 20.1 to 32.2
|
24.8 Percentage of Participants
Interval 18.8 to 30.7
|
SECONDARY outcome
Timeframe: Week 8Population: Intent to treat population.
Clinical remission is defined as a CDAI score \< 150 points if baseline CDAI is \>= 150. If baseline CDAI is \<150, the participant was not considered in remission. participants with missing CDAI scores were considered not in remission according to the missing=no effect imputation. Percentage of participants achieving clinical remission with CDAI \<150 points at Week 8 was presented.
Outcome measures
| Measure |
Placebo
n=203 Participants
Eligible participants were randomized at baseline (Week 0) to receive matching placebo orally for 12 weeks treatment period.
|
GSK1605786A 500 mg Once Daily
n=203 Participants
Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg once daily hard gelatin capsules orally for 12 weeks treatment period.
|
GSK1605786A 500 mg Twice Daily
n=202 Participants
Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg twice daily hard gelatin capsules orally for 12 weeks treatment period.
|
|---|---|---|---|
|
Percentage of Participant Achieving Clinical Remission (CDAI <150 Points) at Week 8
|
12.3 Percentage of participants
Interval 7.8 to 16.8
|
10.3 Percentage of participants
Interval 6.2 to 14.5
|
9.9 Percentage of participants
Interval 5.8 to 14.0
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 8 and Week 12Population: Intent to treat population. Only those participants available at specified time points were analyzed.
The IBDQ is a 32-item IBD-specific health related quality of life instrument evaluating general activities of daily living, intestinal function, social performance, personal interactions, and emotional status. Each item response was graded from 1 to 7 for each area evaluated. A higher score indicated better function in that area. Total IBDQ score was obtained by summing up scores for all 32 questions. Total IBDQ score ranged from 32 to 224. A higher score indicated better quality of life and lower score indicated worse quality of life. Day 1 assessment was considered as Baseline. Change from Baseline was calculated by subtracting value at Baseline from value at Weeks 8 and 12.
Outcome measures
| Measure |
Placebo
n=203 Participants
Eligible participants were randomized at baseline (Week 0) to receive matching placebo orally for 12 weeks treatment period.
|
GSK1605786A 500 mg Once Daily
n=203 Participants
Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg once daily hard gelatin capsules orally for 12 weeks treatment period.
|
GSK1605786A 500 mg Twice Daily
n=202 Participants
Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg twice daily hard gelatin capsules orally for 12 weeks treatment period.
|
|---|---|---|---|
|
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Both Weeks 8 and 12
Week 8
|
13.18 Score on scale
Standard Error 1.728
|
12.06 Score on scale
Standard Error 1.704
|
16.55 Score on scale
Standard Error 1.757
|
|
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Both Weeks 8 and 12
Week 12
|
13.00 Score on scale
Standard Error 1.889
|
12.66 Score on scale
Standard Error 1.863
|
14.86 Score on scale
Standard Error 1.921
|
SECONDARY outcome
Timeframe: Up to Week 12Population: The Safety population comprised of all participants in the intent to treat population except those who did not take at least one dose of investigational product.
Data for number of participants who presented one or more adverse events (serious or non serious) was reported. An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.
Outcome measures
| Measure |
Placebo
n=202 Participants
Eligible participants were randomized at baseline (Week 0) to receive matching placebo orally for 12 weeks treatment period.
|
GSK1605786A 500 mg Once Daily
n=202 Participants
Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg once daily hard gelatin capsules orally for 12 weeks treatment period.
|
GSK1605786A 500 mg Twice Daily
n=201 Participants
Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg twice daily hard gelatin capsules orally for 12 weeks treatment period.
|
|---|---|---|---|
|
Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)
AE
|
141 Participants
|
148 Participants
|
157 Participants
|
|
Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)
SAE
|
18 Participants
|
12 Participants
|
12 Participants
|
Adverse Events
Placebo
GSK1605786A 500 mg Once Daily
GSK1605786A 500 mg Twice Daily
Serious adverse events
| Measure |
Placebo
n=202 participants at risk
Eligible participants were randomized at baseline (Week 0) to receive matching placebo orally for 12 weeks treatment period.
|
GSK1605786A 500 mg Once Daily
n=202 participants at risk
Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg once daily hard gelatin capsules orally for 12 weeks treatment period.
|
GSK1605786A 500 mg Twice Daily
n=201 participants at risk
Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg twice daily hard gelatin capsules orally for 12 weeks treatment period.
|
|---|---|---|---|
|
Gastrointestinal disorders
Crohn's disease
|
2.5%
5/202 • Up to Week 12
Safety population was used to collects AEs
|
2.0%
4/202 • Up to Week 12
Safety population was used to collects AEs
|
0.50%
1/201 • Up to Week 12
Safety population was used to collects AEs
|
|
Gastrointestinal disorders
Abdominal pain
|
0.50%
1/202 • Up to Week 12
Safety population was used to collects AEs
|
0.50%
1/202 • Up to Week 12
Safety population was used to collects AEs
|
0.50%
1/201 • Up to Week 12
Safety population was used to collects AEs
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.50%
1/202 • Up to Week 12
Safety population was used to collects AEs
|
0.50%
1/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/201 • Up to Week 12
Safety population was used to collects AEs
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/202 • Up to Week 12
Safety population was used to collects AEs
|
1.00%
2/201 • Up to Week 12
Safety population was used to collects AEs
|
|
Gastrointestinal disorders
Anal fissure
|
0.50%
1/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/201 • Up to Week 12
Safety population was used to collects AEs
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/202 • Up to Week 12
Safety population was used to collects AEs
|
0.50%
1/201 • Up to Week 12
Safety population was used to collects AEs
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.50%
1/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/201 • Up to Week 12
Safety population was used to collects AEs
|
|
Gastrointestinal disorders
Haematochezia
|
0.50%
1/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/201 • Up to Week 12
Safety population was used to collects AEs
|
|
Gastrointestinal disorders
Ileus
|
0.50%
1/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/201 • Up to Week 12
Safety population was used to collects AEs
|
|
Gastrointestinal disorders
Intestinal fistula
|
0.50%
1/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/201 • Up to Week 12
Safety population was used to collects AEs
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/202 • Up to Week 12
Safety population was used to collects AEs
|
0.50%
1/201 • Up to Week 12
Safety population was used to collects AEs
|
|
Gastrointestinal disorders
Subileus
|
0.50%
1/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/201 • Up to Week 12
Safety population was used to collects AEs
|
|
Infections and infestations
Anal abscess
|
0.00%
0/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/202 • Up to Week 12
Safety population was used to collects AEs
|
1.00%
2/201 • Up to Week 12
Safety population was used to collects AEs
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/202 • Up to Week 12
Safety population was used to collects AEs
|
0.50%
1/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/201 • Up to Week 12
Safety population was used to collects AEs
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/202 • Up to Week 12
Safety population was used to collects AEs
|
0.50%
1/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/201 • Up to Week 12
Safety population was used to collects AEs
|
|
Infections and infestations
Clostridium difficile infection
|
0.50%
1/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/201 • Up to Week 12
Safety population was used to collects AEs
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/202 • Up to Week 12
Safety population was used to collects AEs
|
0.50%
1/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/201 • Up to Week 12
Safety population was used to collects AEs
|
|
Infections and infestations
Salmonellosis
|
0.00%
0/202 • Up to Week 12
Safety population was used to collects AEs
|
0.50%
1/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/201 • Up to Week 12
Safety population was used to collects AEs
|
|
Infections and infestations
Sepsis
|
0.50%
1/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/201 • Up to Week 12
Safety population was used to collects AEs
|
|
Infections and infestations
Subcutaneous abscess
|
0.50%
1/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/201 • Up to Week 12
Safety population was used to collects AEs
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/202 • Up to Week 12
Safety population was used to collects AEs
|
0.50%
1/201 • Up to Week 12
Safety population was used to collects AEs
|
|
Infections and infestations
Varicella
|
0.50%
1/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/201 • Up to Week 12
Safety population was used to collects AEs
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
0.50%
1/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/201 • Up to Week 12
Safety population was used to collects AEs
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/202 • Up to Week 12
Safety population was used to collects AEs
|
0.50%
1/201 • Up to Week 12
Safety population was used to collects AEs
|
|
Injury, poisoning and procedural complications
Postoperative adhesion
|
0.50%
1/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/201 • Up to Week 12
Safety population was used to collects AEs
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/202 • Up to Week 12
Safety population was used to collects AEs
|
0.50%
1/201 • Up to Week 12
Safety population was used to collects AEs
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/202 • Up to Week 12
Safety population was used to collects AEs
|
0.50%
1/201 • Up to Week 12
Safety population was used to collects AEs
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/202 • Up to Week 12
Safety population was used to collects AEs
|
0.50%
1/201 • Up to Week 12
Safety population was used to collects AEs
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/202 • Up to Week 12
Safety population was used to collects AEs
|
0.50%
1/201 • Up to Week 12
Safety population was used to collects AEs
|
|
General disorders
Pyrexia
|
0.00%
0/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/202 • Up to Week 12
Safety population was used to collects AEs
|
1.00%
2/201 • Up to Week 12
Safety population was used to collects AEs
|
|
Investigations
Body temperature increased
|
0.00%
0/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/202 • Up to Week 12
Safety population was used to collects AEs
|
0.50%
1/201 • Up to Week 12
Safety population was used to collects AEs
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/202 • Up to Week 12
Safety population was used to collects AEs
|
0.50%
1/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/201 • Up to Week 12
Safety population was used to collects AEs
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/202 • Up to Week 12
Safety population was used to collects AEs
|
0.50%
1/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/201 • Up to Week 12
Safety population was used to collects AEs
|
|
Eye disorders
Retinal detachment
|
0.50%
1/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/201 • Up to Week 12
Safety population was used to collects AEs
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.50%
1/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/201 • Up to Week 12
Safety population was used to collects AEs
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.50%
1/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/201 • Up to Week 12
Safety population was used to collects AEs
|
|
Psychiatric disorders
Depression
|
0.00%
0/202 • Up to Week 12
Safety population was used to collects AEs
|
0.50%
1/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/201 • Up to Week 12
Safety population was used to collects AEs
|
|
Reproductive system and breast disorders
Prostatism
|
0.00%
0/202 • Up to Week 12
Safety population was used to collects AEs
|
0.50%
1/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/201 • Up to Week 12
Safety population was used to collects AEs
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.50%
1/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/201 • Up to Week 12
Safety population was used to collects AEs
|
|
Vascular disorders
Intermittent claudication
|
0.00%
0/202 • Up to Week 12
Safety population was used to collects AEs
|
0.50%
1/202 • Up to Week 12
Safety population was used to collects AEs
|
0.00%
0/201 • Up to Week 12
Safety population was used to collects AEs
|
Other adverse events
| Measure |
Placebo
n=202 participants at risk
Eligible participants were randomized at baseline (Week 0) to receive matching placebo orally for 12 weeks treatment period.
|
GSK1605786A 500 mg Once Daily
n=202 participants at risk
Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg once daily hard gelatin capsules orally for 12 weeks treatment period.
|
GSK1605786A 500 mg Twice Daily
n=201 participants at risk
Eligible participants were randomized at baseline (Week 0) to receive GSK1605786A 500 mg twice daily hard gelatin capsules orally for 12 weeks treatment period.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
15.3%
31/202 • Number of events 53 • Up to Week 12
Safety population was used to collects AEs
|
15.8%
32/202 • Number of events 53 • Up to Week 12
Safety population was used to collects AEs
|
13.9%
28/201 • Number of events 42 • Up to Week 12
Safety population was used to collects AEs
|
|
Gastrointestinal disorders
Crohn's disease
|
9.9%
20/202 • Number of events 21 • Up to Week 12
Safety population was used to collects AEs
|
11.4%
23/202 • Number of events 27 • Up to Week 12
Safety population was used to collects AEs
|
9.0%
18/201 • Number of events 22 • Up to Week 12
Safety population was used to collects AEs
|
|
Infections and infestations
Nasopharyngitis
|
8.9%
18/202 • Number of events 20 • Up to Week 12
Safety population was used to collects AEs
|
7.9%
16/202 • Number of events 18 • Up to Week 12
Safety population was used to collects AEs
|
10.0%
20/201 • Number of events 23 • Up to Week 12
Safety population was used to collects AEs
|
|
Gastrointestinal disorders
Abdominal pain
|
6.4%
13/202 • Number of events 21 • Up to Week 12
Safety population was used to collects AEs
|
8.4%
17/202 • Number of events 19 • Up to Week 12
Safety population was used to collects AEs
|
11.4%
23/201 • Number of events 25 • Up to Week 12
Safety population was used to collects AEs
|
|
Gastrointestinal disorders
Nausea
|
7.4%
15/202 • Number of events 15 • Up to Week 12
Safety population was used to collects AEs
|
9.4%
19/202 • Number of events 22 • Up to Week 12
Safety population was used to collects AEs
|
9.0%
18/201 • Number of events 18 • Up to Week 12
Safety population was used to collects AEs
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.4%
13/202 • Number of events 14 • Up to Week 12
Safety population was used to collects AEs
|
6.9%
14/202 • Number of events 17 • Up to Week 12
Safety population was used to collects AEs
|
5.0%
10/201 • Number of events 12 • Up to Week 12
Safety population was used to collects AEs
|
|
Gastrointestinal disorders
Dyspepsia
|
2.5%
5/202 • Number of events 5 • Up to Week 12
Safety population was used to collects AEs
|
3.5%
7/202 • Number of events 10 • Up to Week 12
Safety population was used to collects AEs
|
11.4%
23/201 • Number of events 27 • Up to Week 12
Safety population was used to collects AEs
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
4/202 • Number of events 4 • Up to Week 12
Safety population was used to collects AEs
|
5.9%
12/202 • Number of events 14 • Up to Week 12
Safety population was used to collects AEs
|
7.5%
15/201 • Number of events 16 • Up to Week 12
Safety population was used to collects AEs
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER