Trial Outcomes & Findings for Comparison of Two KADIAN 10 mg Capsules to a KADIAN 20 mg Capsule Under Fed Conditions (NCT NCT00759915)
NCT ID: NCT00759915
Last Updated: 2010-08-17
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
36 participants
Primary outcome timeframe
0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs
Results posted on
2010-08-17
Participant Flow
Participant milestones
| Measure |
Period 1: Treatment Aor B
Treatment A (test product) followed by Treatment B (reference product)
|
Period 2: Treatment A or B
Treatment B (reference product) followed by Treatment A (test product)
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
|
Overall Study
COMPLETED
|
17
|
17
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Period 1: Treatment Aor B
Treatment A (test product) followed by Treatment B (reference product)
|
Period 2: Treatment A or B
Treatment B (reference product) followed by Treatment A (test product)
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Comparison of Two KADIAN 10 mg Capsules to a KADIAN 20 mg Capsule Under Fed Conditions
Baseline characteristics by cohort
| Measure |
Period 1: Treatment Aor B
n=18 Participants
Treatment A (test product) followed by Treatment B (reference product)
|
Period 2: Treatment A or B
n=18 Participants
Treatment B (reference product) followed by Treatment A (test product)
|
Total
n=36 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
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
36 years
STANDARD_DEVIATION 12 • n=5 Participants
|
29 years
STANDARD_DEVIATION 10 • n=7 Participants
|
33 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
18 participants
n=7 Participants
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrsOutcome measures
| Measure |
KADIAN (2 x 10mg) Capsules
n=35 Participants
|
KADIAN 20mg Capsules
n=35 Participants
|
|---|---|---|
|
Maximum Plasma Morphine Concentration
|
4.60 ng/mL
Standard Deviation 1.82
|
4.29 ng/mL
Standard Deviation 2.13
|
SECONDARY outcome
Timeframe: 0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrsOutcome measures
| Measure |
KADIAN (2 x 10mg) Capsules
n=35 Participants
|
KADIAN 20mg Capsules
n=35 Participants
|
|---|---|---|
|
Time of Maximum Plasma Morphine Concentration
|
12.00 Hr
Full Range 3.83 • Interval 6.0 to 24.0
|
12.00 Hr
Full Range 5.17 • Interval 6.5 to 30.0
|
SECONDARY outcome
Timeframe: 0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrsOutcome measures
| Measure |
KADIAN (2 x 10mg) Capsules
n=35 Participants
|
KADIAN 20mg Capsules
n=35 Participants
|
|---|---|---|
|
Area Under the Curve to the Last Measurable Time Point for Plasma Morphine
|
76.44 hr*ng/mL
Standard Deviation 16.12
|
76.33 hr*ng/mL
Standard Deviation 19.24
|
SECONDARY outcome
Timeframe: 0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,36,48 hrsOutcome measures
| Measure |
KADIAN (2 x 10mg) Capsules
n=32 Participants
|
KADIAN 20mg Capsules
n=32 Participants
|
|---|---|---|
|
Area Under the Curve to Infinity for Plasma Morphine
|
90.09 hr*ng/mL
Standard Deviation 16.18
|
92.43 hr*ng/mL
Standard Deviation 23.46
|
Adverse Events
Arm 1: Treatment A Followed by Treatment B
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Arm 2: Treatment B Followed by Treatment A
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm 1: Treatment A Followed by Treatment B
|
Arm 2: Treatment B Followed by Treatment A
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
11.1%
2/18 • Number of events 3
|
0.00%
0/18
|
|
Nervous system disorders
Headache
|
5.6%
1/18 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
|
Investigations
Alanine Aminotransferase Increased
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Gastrointestinal disorders
Dry Mouth
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Musculoskeletal and connective tissue disorders
Pain in Arm
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Infections and infestations
Perirectal Abscess
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
General disorders
Pain
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Blood and lymphatic system disorders
Paratracheal Lymphadenopathy
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Infections and infestations
Tooth Abscess
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place