Trial Outcomes & Findings for A Study of the Efficacy and Safety of Amitriptyline/Ketamine Topical Cream in Patients With Diabetic Peripheral Neuropathy (NCT NCT00476151)
NCT ID: NCT00476151
Last Updated: 2011-05-17
Results Overview
diabetic peripheral neuropathy (DPN) pain is recorded on a numerical rating scale of 0 (no pain) to 10 (worst possible pain) at baseline and the endpoint of 4 weeks.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
226 participants
Primary outcome timeframe
baseline and 4 weeks treatment
Results posted on
2011-05-17
Participant Flow
Participant milestones
| Measure |
Placebo Cream
vehicle cream applied twice daily for 4 weeks
|
Amitriptyline 4% Ketamine 2% Cream
active topical cream applied twice daily for 4 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
112
|
114
|
|
Overall Study
COMPLETED
|
109
|
107
|
|
Overall Study
NOT COMPLETED
|
3
|
7
|
Reasons for withdrawal
| Measure |
Placebo Cream
vehicle cream applied twice daily for 4 weeks
|
Amitriptyline 4% Ketamine 2% Cream
active topical cream applied twice daily for 4 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Protocol Violation
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Physician Decision
|
0
|
2
|
Baseline Characteristics
A Study of the Efficacy and Safety of Amitriptyline/Ketamine Topical Cream in Patients With Diabetic Peripheral Neuropathy
Baseline characteristics by cohort
| Measure |
Placebo Cream
n=112 Participants
vehicle cream applied twice daily for 4 weeks
|
Amitriptyline 4% Ketamine 2% Cream
n=114 Participants
active topical cream applied twice daily for 4 weeks
|
Total
n=226 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
|
86 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
180 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
26 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Age Continuous
|
55.05 years
STANDARD_DEVIATION 11.044 • n=5 Participants
|
56.06 years
STANDARD_DEVIATION 9.350 • n=7 Participants
|
55.56 years
STANDARD_DEVIATION 10.214 • n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Region of Enrollment
India
|
112 participants
n=5 Participants
|
114 participants
n=7 Participants
|
226 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 4 weeks treatmentPopulation: ITT (Intention To Treat) completer population, LOCF (Last Observation Carried Forward) imputation
diabetic peripheral neuropathy (DPN) pain is recorded on a numerical rating scale of 0 (no pain) to 10 (worst possible pain) at baseline and the endpoint of 4 weeks.
Outcome measures
| Measure |
Placebo Cream
n=108 Participants
vehicle cream applied twice daily for 4 weeks
|
Amitriptyline 4% Ketamine 2% Cream
n=106 Participants
active topical cream applied twice daily for 4 weeks
|
|---|---|---|
|
Placebo vs. Active Comparison of the Change From Average Pain at Baseline to Average Pain at 4 Weeks.
|
1.64 units on a scale
Interval 1.21 to 2.06
|
2.12 units on a scale
Interval 1.72 to 2.53
|
Adverse Events
Placebo Cream
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Amitriptyline 4% Ketamine 2% Cream
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo Cream
n=112 participants at risk
vehicle cream applied twice daily for 4 weeks
|
Amitriptyline 4% Ketamine 2% Cream
n=114 participants at risk
active topical cream applied twice daily for 4 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Eosiniphilia
|
1.8%
2/112 • Number of events 2
|
0.00%
0/114
|
|
Blood and lymphatic system disorders
Anemia
|
0.89%
1/112 • Number of events 1
|
0.00%
0/114
|
|
Eye disorders
Conjunctivitis
|
0.89%
1/112 • Number of events 1
|
0.00%
0/114
|
|
General disorders
Pain
|
0.89%
1/112 • Number of events 1
|
0.88%
1/114 • Number of events 1
|
|
General disorders
Pyrexia
|
0.89%
1/112 • Number of events 1
|
0.88%
1/114 • Number of events 1
|
|
General disorders
Edema
|
0.89%
1/112 • Number of events 1
|
0.00%
0/114
|
|
Infections and infestations
Rhinitis
|
0.00%
0/112
|
0.88%
1/114 • Number of events 1
|
|
Infections and infestations
Upper Respiratory Infection
|
0.00%
0/112
|
0.88%
1/114 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/112
|
3.5%
4/114 • Number of events 4
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.89%
1/112 • Number of events 1
|
2.6%
3/114 • Number of events 3
|
|
Investigations
Blood urea increased
|
2.7%
3/112 • Number of events 3
|
0.88%
1/114 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
0.89%
1/112 • Number of events 1
|
1.8%
2/114 • Number of events 2
|
|
Investigations
Body temperature fluctuation
|
0.89%
1/112 • Number of events 1
|
0.00%
0/114
|
|
Investigations
Electrocardiogram QT prolonged
|
0.89%
1/112 • Number of events 1
|
0.00%
0/114
|
|
Investigations
Urine analysis abnormal
|
0.89%
1/112 • Number of events 1
|
0.00%
0/114
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.89%
1/112 • Number of events 1
|
0.88%
1/114 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.89%
1/112 • Number of events 1
|
0.00%
0/114
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.89%
1/112 • Number of events 1
|
0.00%
0/114
|
|
Nervous system disorders
Headache
|
0.00%
0/112
|
0.88%
1/114 • Number of events 1
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/112
|
0.88%
1/114 • Number of events 1
|
|
Nervous system disorders
Somnolence
|
0.00%
0/112
|
0.88%
1/114 • Number of events 1
|
|
Nervous system disorders
Dysesthesia
|
2.7%
3/112 • Number of events 3
|
7.0%
8/114 • Number of events 8
|
|
Renal and urinary disorders
Pyuria
|
1.8%
2/112 • Number of events 2
|
0.00%
0/114
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.8%
2/112 • Number of events 2
|
0.00%
0/114
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.8%
2/112 • Number of events 2
|
0.00%
0/114
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/112
|
0.88%
1/114 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/112
|
0.88%
1/114 • Number of events 1
|
|
Vascular disorders
Flushing
|
1.8%
2/112 • Number of events 2
|
0.88%
1/114 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place