Trial Outcomes & Findings for Safety and Efficacy of Once-Daily KRP-104 in Type 2 Diabetics With Inadequate Glycemic Control on Metformin Alone (NCT NCT00995345)
NCT ID: NCT00995345
Last Updated: 2014-06-26
Results Overview
Mean Change in HbA1c (%) from Baseline to Week 24 with LOCF, ITT population LS mean (SE)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
403 participants
Primary outcome timeframe
Week 24
Results posted on
2014-06-26
Participant Flow
Conducted in 55 medical clinics in 6 countries: US, Guatemala, South Africa, Russia, Czech Republic, Poland. First site opened 19 October 2009.
Variable screening duration to allow for wash-out of one oral therapy, optimization and stabilization of dose on metformin monotherapy (\>= 10 weeks);followed by 2 week placebo run-in. Fasting CBG \<240 mg/dL at start of run in and prior to randomization required.
Participant milestones
| Measure |
Placebo
Tablet
|
Dose 1: KRP-104
40 mg QD
|
Dose 2: KRP-104
80 mg QD
|
Dose 3: KRP-104
100 mg QD
|
Dose 4: KRP-104
20 mg /120 mg QD (dose switch at week12)
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
81
|
81
|
80
|
81
|
80
|
|
Overall Study
COMPLETED
|
70
|
74
|
73
|
76
|
75
|
|
Overall Study
NOT COMPLETED
|
11
|
7
|
7
|
5
|
5
|
Reasons for withdrawal
| Measure |
Placebo
Tablet
|
Dose 1: KRP-104
40 mg QD
|
Dose 2: KRP-104
80 mg QD
|
Dose 3: KRP-104
100 mg QD
|
Dose 4: KRP-104
20 mg /120 mg QD (dose switch at week12)
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
1
|
3
|
1
|
|
Overall Study
Adverse Event
|
3
|
1
|
2
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
2
|
1
|
0
|
|
Overall Study
all other reasons combined
|
2
|
2
|
2
|
1
|
3
|
Baseline Characteristics
Safety and Efficacy of Once-Daily KRP-104 in Type 2 Diabetics With Inadequate Glycemic Control on Metformin Alone
Baseline characteristics by cohort
| Measure |
Placebo
n=81 Participants
Tablet
|
Dose 1: KRP-104
n=81 Participants
40 mg QD
|
Dose 2: KRP-104
n=80 Participants
80 mg QD
|
Dose 3: KRP-104
n=81 Participants
100 mg QD
|
Dose 4: KRP-104
n=80 Participants
20 mg QD (weeks 1-12)/120 mg QD (weeks 12-24)
|
Total
n=403 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
60 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
73 Participants
n=21 Participants
|
332 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
21 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
71 Participants
n=10 Participants
|
|
Age, Continuous
|
57.3 years
STANDARD_DEVIATION 9.43 • n=5 Participants
|
54.2 years
STANDARD_DEVIATION 10.59 • n=7 Participants
|
55.7 years
STANDARD_DEVIATION 9.10 • n=5 Participants
|
56.3 years
STANDARD_DEVIATION 9.40 • n=4 Participants
|
55.5 years
STANDARD_DEVIATION 8.27 • n=21 Participants
|
55.8 years
STANDARD_DEVIATION 9.40 • n=10 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
259 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
144 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
20 participants
n=7 Participants
|
21 participants
n=5 Participants
|
21 participants
n=4 Participants
|
20 participants
n=21 Participants
|
103 participants
n=10 Participants
|
|
Region of Enrollment
Czech Republic
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
5 participants
n=5 Participants
|
6 participants
n=4 Participants
|
5 participants
n=21 Participants
|
28 participants
n=10 Participants
|
|
Region of Enrollment
Poland
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
4 participants
n=4 Participants
|
3 participants
n=21 Participants
|
16 participants
n=10 Participants
|
|
Region of Enrollment
Guatemala
|
16 participants
n=5 Participants
|
15 participants
n=7 Participants
|
15 participants
n=5 Participants
|
14 participants
n=4 Participants
|
16 participants
n=21 Participants
|
76 participants
n=10 Participants
|
|
Region of Enrollment
South Africa
|
21 participants
n=5 Participants
|
23 participants
n=7 Participants
|
23 participants
n=5 Participants
|
22 participants
n=4 Participants
|
22 participants
n=21 Participants
|
111 participants
n=10 Participants
|
|
Region of Enrollment
Russian Federation
|
13 participants
n=5 Participants
|
14 participants
n=7 Participants
|
14 participants
n=5 Participants
|
14 participants
n=4 Participants
|
14 participants
n=21 Participants
|
69 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: Conducted analyses of ITT population of change in HbA1c from baseline (Week 0) to Week 24. If the Wk 24 measurement was missing, the last valid post-baseline observation (LOCF) algorithm was used to impute Week 24 value (1 on-treatment value required). Efficacy data collected after the initiation of rescue therapy was excluded from the analyses.
Mean Change in HbA1c (%) from Baseline to Week 24 with LOCF, ITT population LS mean (SE)
Outcome measures
| Measure |
Placebo
n=78 Participants
Tablet
|
Dose 1: KRP-104
n=79 Participants
40 mg QD
|
Dose 2: KRP-104
n=79 Participants
80 mg QD
|
Dose 3: KRP-104
n=80 Participants
100 mg QD
|
Dose 4: KRP-104
n=79 Participants
20 mg QD (weeks 1-12)/120 mg QD (weeks 12-24)
|
|---|---|---|---|---|---|
|
Change in HbA1c From Baseline (Week 0) to Week 24
|
-0.09 % HbA1c
95% Confidence Interval 0.097 • Interval -0.28 to 0.1
|
-0.41 % HbA1c
95% Confidence Interval 0 • Interval -0.6 to -0.22
|
-0.70 % HbA1c
Interval -0.89 to -0.51
|
-0.71 % HbA1c
Interval -0.89 to -0.52
|
-0.73 % HbA1c
Interval -0.92 to -0.54
|
SECONDARY outcome
Timeframe: 24 weeksMean Change in Body Weight (kg) from Baseline to Week 24 with LOCF- ITT
Outcome measures
| Measure |
Placebo
n=78 Participants
Tablet
|
Dose 1: KRP-104
n=79 Participants
40 mg QD
|
Dose 2: KRP-104
n=79 Participants
80 mg QD
|
Dose 3: KRP-104
n=80 Participants
100 mg QD
|
Dose 4: KRP-104
n=79 Participants
20 mg QD (weeks 1-12)/120 mg QD (weeks 12-24)
|
|---|---|---|---|---|---|
|
Change in Body Weight
|
-0.73 kg body weight on scale
Standard Error 0.303
|
-1.13 kg body weight on scale
Standard Error 0.303
|
-1.31 kg body weight on scale
Standard Error 0.302
|
-0.70 kg body weight on scale
Standard Error 0.300
|
-0.18 kg body weight on scale
Standard Error 0.302
|
SECONDARY outcome
Timeframe: 24 weeksSubjects Achieving Target of Hemoglobin A1c \<7.0% at Week 24 with LOCF - Intent-to-Treat Population
Outcome measures
| Measure |
Placebo
n=78 Participants
Tablet
|
Dose 1: KRP-104
n=79 Participants
40 mg QD
|
Dose 2: KRP-104
n=79 Participants
80 mg QD
|
Dose 3: KRP-104
n=80 Participants
100 mg QD
|
Dose 4: KRP-104
n=79 Participants
20 mg QD (weeks 1-12)/120 mg QD (weeks 12-24)
|
|---|---|---|---|---|---|
|
Percentage of Patients Achieving HbA1c Less Than 7%
|
23.08 % of subjects in group
|
31.65 % of subjects in group
|
49.37 % of subjects in group
|
43.75 % of subjects in group
|
41.77 % of subjects in group
|
SECONDARY outcome
Timeframe: 24 weeks of treatment.Percentage of Subjects Requiring Rescue Therapy - Intent-to-Treat Population
Outcome measures
| Measure |
Placebo
n=79 Participants
Tablet
|
Dose 1: KRP-104
n=79 Participants
40 mg QD
|
Dose 2: KRP-104
n=79 Participants
80 mg QD
|
Dose 3: KRP-104
n=80 Participants
100 mg QD
|
Dose 4: KRP-104
n=79 Participants
20 mg QD (weeks 1-12)/120 mg QD (weeks 12-24)
|
|---|---|---|---|---|---|
|
Percentage of Patients Requiring Rescue Therapy for Elevated Glucose
|
6.33 % of subjects in group
|
10.1 % of subjects in group
|
5.06 % of subjects in group
|
3.75 % of subjects in group
|
3.8 % of subjects in group
|
Adverse Events
Placebo
Serious events: 3 serious events
Other events: 24 other events
Deaths: 0 deaths
Dose 1: KRP-104
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Dose 2: KRP-104
Serious events: 4 serious events
Other events: 16 other events
Deaths: 0 deaths
Dose 3: KRP-104
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Dose 4: KRP-104
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=81 participants at risk
Tablet
|
Dose 1: KRP-104
n=81 participants at risk
40 mg QD
|
Dose 2: KRP-104
n=80 participants at risk
80 mg QD
|
Dose 3: KRP-104
n=81 participants at risk
100 mg QD
|
Dose 4: KRP-104
n=80 participants at risk
20 mg QD (weeks 1-12)/120 mg QD (weeks 12-24)
|
|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer (left breast)
|
1.2%
1/81 • Number of events 1 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
0.00%
0/81 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
0.00%
0/80 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
0.00%
0/81 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
0.00%
0/80 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
|
Infections and infestations
tuberculosis meningitis
|
1.2%
1/81 • Number of events 1 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
0.00%
0/81 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
0.00%
0/80 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
0.00%
0/81 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
0.00%
0/80 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
1.2%
1/81 • Number of events 1 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
0.00%
0/81 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
0.00%
0/80 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
0.00%
0/81 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
0.00%
0/80 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
|
Injury, poisoning and procedural complications
Fracture Of The Left Anterior Lamina Papyracea (Ethmoid Bone)
|
0.00%
0/81 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
1.2%
1/81 • Number of events 1 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
0.00%
0/80 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
0.00%
0/81 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
0.00%
0/80 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
|
Infections and infestations
Lyme Disease
|
0.00%
0/81 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
1.2%
1/81 • Number of events 1 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
0.00%
0/80 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
0.00%
0/81 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
0.00%
0/80 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/81 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
0.00%
0/81 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
1.2%
1/80 • Number of events 1 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
0.00%
0/81 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
0.00%
0/80 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/81 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
0.00%
0/81 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
1.2%
1/80 • Number of events 1 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
0.00%
0/81 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
0.00%
0/80 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
lung cancer
|
0.00%
0/81 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
0.00%
0/81 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
1.2%
1/80 • Number of events 1 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
0.00%
0/81 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
0.00%
0/80 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
|
Hepatobiliary disorders
Cholecystolithiasis
|
0.00%
0/81 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
0.00%
0/81 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
1.2%
1/80 • Number of events 1 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
0.00%
0/81 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
0.00%
0/80 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
|
Musculoskeletal and connective tissue disorders
Intractable Low Back Pain
|
0.00%
0/81 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
0.00%
0/81 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
0.00%
0/80 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
1.2%
1/81 • Number of events 1 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
0.00%
0/80 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/81 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
0.00%
0/81 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
0.00%
0/80 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
0.00%
0/81 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
1.2%
1/80 • Number of events 1 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
Other adverse events
| Measure |
Placebo
n=81 participants at risk
Tablet
|
Dose 1: KRP-104
n=81 participants at risk
40 mg QD
|
Dose 2: KRP-104
n=80 participants at risk
80 mg QD
|
Dose 3: KRP-104
n=81 participants at risk
100 mg QD
|
Dose 4: KRP-104
n=80 participants at risk
20 mg QD (weeks 1-12)/120 mg QD (weeks 12-24)
|
|---|---|---|---|---|---|
|
Infections and infestations
Urinary tract infection
|
6.2%
5/81 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
7.4%
6/81 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
11.2%
9/80 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
6.2%
5/81 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
7.5%
6/80 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
|
Infections and infestations
Influenza
|
6.2%
5/81 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
4.9%
4/81 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
2.5%
2/80 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
4.9%
4/81 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
6.2%
5/80 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.9%
4/81 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
3.7%
3/81 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
1.2%
1/80 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
2.5%
2/81 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
5.0%
4/80 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
|
Gastrointestinal disorders
Diarrhea
|
4.9%
4/81 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
1.2%
1/81 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
2.5%
2/80 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
6.2%
5/81 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
2.5%
2/80 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
|
Vascular disorders
Hypertension
|
7.4%
6/81 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
2.5%
2/81 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
2.5%
2/80 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
1.2%
1/81 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
2.5%
2/80 • From first site open on 19 October 2009 through 30 days after last subject out on 20 January 2011, approximately 1 year 5 months.
Only treatment related adverse events were reported in the clinical study report. There were no occurrences of serious adverse events that were considered related to drug, thus none met criterion of reportable event.
|
Additional Information
Dr. Diane Plotkin, Sr. Director Clinical Development
ActivX Biosciences
Phone: 858-558-5558
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee No explicit limitations on discussion by PI. PI may not publish results before a coordinated multicenter publication has been submitted for publication, marketing approval obtained, or until 7 years after the study has ended, whichever occurs first. Thereafter, the study site will have the opportunity to publish the results of the study, provided that the Sponsor has had the opportunity to review and comment on the study site's proposed publication prior to it being submitted for publication.
- Publication restrictions are in place
Restriction type: OTHER