Trial Outcomes & Findings for Comparison of Two KADIAN 10 mg Capsules to a KADIAN 20 mg Capsule Under Fasted Conditions (NCT NCT00759902)
NCT ID: NCT00759902
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 A or 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
|
18
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Period 1: Treatment A or 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
Adverse Event
|
0
|
1
|
Baseline Characteristics
Comparison of Two KADIAN 10 mg Capsules to a KADIAN 20 mg Capsule Under Fasted Conditions
Baseline characteristics by cohort
| Measure |
Period 1: Treatment A or 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
|
31.6 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
31.7 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
31.7 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 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 10 mg Capsules
n=35 Participants
2 x 10 mg KADIAN capsules
|
KADIAN 20 mg Capsules
n=35 Participants
1 x 20 mg KADIAN capsules
|
|---|---|---|
|
Maximum Plasma Morphine Concentration
|
5.23 ng/mL
Standard Deviation 2.01
|
4.15 ng/mL
Standard Deviation 1.35
|
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 10 mg Capsules
n=35 Participants
2 x 10 mg KADIAN capsules
|
KADIAN 20 mg Capsules
n=35 Participants
1 x 20 mg KADIAN capsules
|
|---|---|---|
|
Time of Maximum Plasma Morphine Concentration
|
7.50 hr
Full Range 2.15 • Interval 6.0 to 12.0
|
7.50 hr
Full Range 3.82 • Interval 6.0 to 18.0
|
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 10 mg Capsules
n=35 Participants
2 x 10 mg KADIAN capsules
|
KADIAN 20 mg Capsules
n=35 Participants
1 x 20 mg KADIAN capsules
|
|---|---|---|
|
Area Under the Curve to the Last Measurable Time Point for Plasma Morphine
|
84.45 hr*ng/mL
Standard Deviation 22.29
|
82.94 hr*ng/mL
Standard Deviation 21.01
|
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 10 mg Capsules
n=31 Participants
2 x 10 mg KADIAN capsules
|
KADIAN 20 mg Capsules
n=33 Participants
1 x 20 mg KADIAN capsules
|
|---|---|---|
|
Area Under the Curve to Infinity for Plasma Morphine
|
102.1 hr*ng/mL
Standard Deviation 31.63
|
100.0 hr*ng/mL
Standard Deviation 28.52
|
Adverse Events
Arm 1: Treatment A Followed by Treatment B
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Arm 2: Treatment B Followed by Treatment A
Serious events: 0 serious events
Other events: 10 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
Headache
|
16.7%
3/18 • Number of events 3
|
33.3%
6/18 • Number of events 6
|
|
Gastrointestinal disorders
Nausea
|
22.2%
4/18 • Number of events 4
|
16.7%
3/18 • Number of events 3
|
|
Gastrointestinal disorders
Bowel
|
5.6%
1/18 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
|
Cardiac disorders
Chest Pain
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Gastrointestinal disorders
Constipation
|
11.1%
2/18 • Number of events 2
|
0.00%
0/18
|
|
Gastrointestinal disorders
Flatulence
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.6%
1/18 • Number of events 1
|
11.1%
2/18 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
5.6%
1/18 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
Paraesthesia
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Cardiac disorders
Palpitations
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Psychiatric disorders
Abnormal Dreams
|
0.00%
0/18
|
5.6%
1/18 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin Laceration
|
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
|
|
Infections and infestations
Genital Herpes
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin Burning Sensation
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
General disorders
Hunger
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
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