Trial Outcomes & Findings for A Trial in Painful Diabetic Peripheral Neuropathy With GRT3983Y (NCT NCT01056315)
NCT ID: NCT01056315
Last Updated: 2019-10-28
Results Overview
The primary efficacy endpoint is the change from baseline in the mean of the daily average pain intensity scores (on an 11-point NRS) over the last 7 days of the 12-week maintenance (Week 16).
TERMINATED
PHASE2
553 participants
Baseline; last 7 days of 12-week maintenance
2019-10-28
Participant Flow
503 participants were excluded from the trial before assignment to a treatment group because they did not meet the inclusion and or exclusion criteria.
Participant milestones
| Measure |
GRT3983Y
|
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
23
|
|
Overall Study
COMPLETED
|
13
|
12
|
|
Overall Study
NOT COMPLETED
|
14
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Trial in Painful Diabetic Peripheral Neuropathy With GRT3983Y
Baseline characteristics by cohort
| Measure |
GRT3983Y
n=27 Participants
|
Placebo
n=23 Participants
|
Total
n=50 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
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Continuous
|
59.38 years
STANDARD_DEVIATION 8.942 • n=5 Participants
|
60.27 years
STANDARD_DEVIATION 10.438 • n=7 Participants
|
59.79 years
STANDARD_DEVIATION 9.568 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
23 participants
n=7 Participants
|
50 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline; last 7 days of 12-week maintenancePopulation: Efficacy data were not analyzed because of the limited number of subjects with efficacy data at the time of the early termination of the trial.
The primary efficacy endpoint is the change from baseline in the mean of the daily average pain intensity scores (on an 11-point NRS) over the last 7 days of the 12-week maintenance (Week 16).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Daily scores over entire 12 week maintenancePopulation: Efficacy data were not analyzed because of the limited number of subjects with efficacy data at the time of the early termination of the trial.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Last 7 days of 12-week maintenancePopulation: Efficacy data were not analyzed because of the limited number of subjects with efficacy data at the time of the early termination of the trial.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; daily scores over each week of maintenancePopulation: Efficacy data were not analyzed because of the limited number of subjects with efficacy data at the time of the early termination of the trial.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; weekly meanPopulation: Efficacy data were not analyzed because of the limited number of subjects with efficacy data at the time of the early termination of the trial.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, weekly meanPopulation: Efficacy data were not analyzed because of the limited number of subjects with efficacy data at the time of the early termination of the trial.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, weekly meanPopulation: Efficacy data were not analyzed because of the limited number of subjects with efficacy data at the time of the early termination of the trial.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, weekly meanPopulation: Efficacy data were not analyzed because of the limited number of subjects with efficacy data at the time of the early termination of the trial.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 29, Day 71 and Day 113.Population: Efficacy data were not analyzed because of the limited number of subjects with efficacy data at the time of the early termination of the trial.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Day 29, Day 71 and Day 113.Population: Efficacy data were not analyzed because of the limited number of subjects with efficacy data at the time of the early termination of the trial.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Day 29, Day 71 and Day 113.Population: Efficacy data were not analyzed because of the limited number of subjects with efficacy data at the time of the early termination of the trial.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Day 29, Day 71 and Day 113.Population: Efficacy data were not analyzed because of the limited number of subjects with efficacy data at the time of the early termination of the trial.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Day 29, Day 71 and Day 113.Population: Efficacy data were not analyzed because of the limited number of subjects with efficacy data at the time of the early termination of the trial.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to time to treatment discontinuationPopulation: Efficacy data were not analyzed because of the limited number of subjects with efficacy data at the time of the early termination of the trial.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4-week titration phasePopulation: Efficacy data were not analyzed because of the limited number of subjects with efficacy data at the time of the early termination of the trial.
Outcome measures
Outcome data not reported
Adverse Events
GRT3983Y
Placebo
Serious adverse events
| Measure |
GRT3983Y
n=27 participants at risk
|
Placebo
n=23 participants at risk
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/27
|
4.3%
1/23 • Number of events 1
|
|
Cardiac disorders
Coronary artery disease
|
3.7%
1/27 • Number of events 1
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
3.7%
1/27 • Number of events 1
|
0.00%
0/23
|
Other adverse events
| Measure |
GRT3983Y
n=27 participants at risk
|
Placebo
n=23 participants at risk
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
37.0%
10/27 • Number of events 13
|
13.0%
3/23 • Number of events 3
|
|
Gastrointestinal disorders
Constipation
|
14.8%
4/27 • Number of events 5
|
8.7%
2/23 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
7.4%
2/27 • Number of events 2
|
0.00%
0/23
|
|
Gastrointestinal disorders
Abdominal pain
|
3.7%
1/27 • Number of events 1
|
13.0%
3/23 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/27
|
13.0%
3/23 • Number of events 3
|
|
Nervous system disorders
Dizziness
|
14.8%
4/27 • Number of events 4
|
4.3%
1/23 • Number of events 1
|
|
Nervous system disorders
Somnolence
|
14.8%
4/27 • Number of events 5
|
4.3%
1/23 • Number of events 2
|
|
Nervous system disorders
Headache
|
11.1%
3/27 • Number of events 4
|
8.7%
2/23 • Number of events 2
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/27
|
8.7%
2/23 • Number of events 2
|
|
Infections and infestations
Upper respiratory tract infection
|
3.7%
1/27 • Number of events 1
|
13.0%
3/23 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.4%
2/27 • Number of events 2
|
4.3%
1/23 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.4%
2/27 • Number of events 2
|
0.00%
0/23
|
|
Psychiatric disorders
Insomnia
|
7.4%
2/27 • Number of events 2
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/27
|
13.0%
3/23 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/27
|
8.7%
2/23 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee It is the Institution and Principal Investigator's obligation not to publish any information declaration, invention or whatsoever which is in connection with this Agreement without the prior written consent of the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER