Trial Outcomes & Findings for A Comparison of the Analgesic Efficacy and Safety of Once Daily Tramadol OAD Tablets to Twice Daily Tramadol BID for the Treatment of Osteoarthritis of the Knee (Extension Protocol) and Open Label Safety Follow-Up (NCT NCT00912015)
NCT ID: NCT00912015
Last Updated: 2012-04-30
Results Overview
Spontaneous adverse events were recorded for patients who received the same dose for at least 350 days. A treatment emergent adverse event (TEAE) was associated to the dose level on which a patient was 2 days prior to the TEAE. Only TEAEs which could be associated with the dose level on which the patient was for the longest time were considered.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
238 participants
Primary outcome timeframe
12 months
Results posted on
2012-04-30
Participant Flow
Participant milestones
| Measure |
Tramadol OAD 200mg
All Patients who Received 1x200 mg Tramadol OAD Tablet daily for at Least 350 days.
OAD = Once-A-Day.
|
Tramadol OAD 300mg
All Patients who Received 1x300 mg Tramadol OAD Tablet daily for at Least 350 days.
OAD = Once-A-Day.
|
Tramadol OAD 400mg
All Patients who Received 1x400 mg Tramadol OAD Tablet daily for at Least 350 days.
OAD = Once-A-Day.
|
Tramadol OAD 100mg
All Patients who Received 1x100 mg Tramadol OAD Tablet daily for at Least 350 days.
OAD = Once-A-Day.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
141
|
70
|
25
|
2
|
|
Overall Study
COMPLETED
|
125
|
62
|
22
|
0
|
|
Overall Study
NOT COMPLETED
|
16
|
8
|
3
|
2
|
Reasons for withdrawal
| Measure |
Tramadol OAD 200mg
All Patients who Received 1x200 mg Tramadol OAD Tablet daily for at Least 350 days.
OAD = Once-A-Day.
|
Tramadol OAD 300mg
All Patients who Received 1x300 mg Tramadol OAD Tablet daily for at Least 350 days.
OAD = Once-A-Day.
|
Tramadol OAD 400mg
All Patients who Received 1x400 mg Tramadol OAD Tablet daily for at Least 350 days.
OAD = Once-A-Day.
|
Tramadol OAD 100mg
All Patients who Received 1x100 mg Tramadol OAD Tablet daily for at Least 350 days.
OAD = Once-A-Day.
|
|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
8
|
8
|
3
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
6
|
0
|
0
|
1
|
Baseline Characteristics
A Comparison of the Analgesic Efficacy and Safety of Once Daily Tramadol OAD Tablets to Twice Daily Tramadol BID for the Treatment of Osteoarthritis of the Knee (Extension Protocol) and Open Label Safety Follow-Up
Baseline characteristics by cohort
| Measure |
Tramadol OAD 200mg
n=141 Participants
All Patients who Received 1x200 mg Tramadol OAD Tablet daily for at Least 350 days.
OAD = Once-A-Day.
|
Tramadol OAD 300mg
n=70 Participants
All Patients who Received 1x300 mg Tramadol OAD Tablet daily for at Least 350 days.
OAD = Once-A-Day.
|
Tramadol OAD 400mg
n=25 Participants
All Patients who Received 1x400 mg Tramadol OAD Tablet daily for at Least 350 days.
OAD = Once-A-Day.
|
Tramadol OAD 100mg
n=2 Participants
All Patients who Received 1x100 mg Tramadol OAD Tablet daily for at Least 350 days.
OAD = Once-A-Day.
|
Total
n=238 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
|
|
Age, Categorical
Between 18 and 65 years
|
87 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
147 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
54 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
91 Participants
n=21 Participants
|
|
Age Continuous
|
60.1 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
60.5 years
STANDARD_DEVIATION 8.8 • n=7 Participants
|
58.5 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
56.0 years
STANDARD_DEVIATION 5.7 • n=4 Participants
|
60.0 years
STANDARD_DEVIATION 9.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
123 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
203 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Patients who received the same dose for at least 350 days (12 months)
Spontaneous adverse events were recorded for patients who received the same dose for at least 350 days. A treatment emergent adverse event (TEAE) was associated to the dose level on which a patient was 2 days prior to the TEAE. Only TEAEs which could be associated with the dose level on which the patient was for the longest time were considered.
Outcome measures
| Measure |
Tramadol OAD 200mg
n=43 Participants
All Patients who Received 1x200 mg Tramadol OAD Tablet daily for at Least 350 days.
OAD = Once-A-Day.
|
Tramadol OAD 300mg
n=24 Participants
All Patients who Received 1x300 mg Tramadol OAD Tablet daily for at Least 350 days.
OAD = Once-A-Day.
|
Tramadol OAD 400mg
n=8 Participants
All Patients who Received 1x400 mg Tramadol OAD Tablet daily for at Least 350 days.
OAD = Once-A-Day.
|
Tramadol OAD 100mg
All Patients who Received 1x100 mg Tramadol OAD Tablet daily for at Least 350 days.
OAD = Once-A-Day.
|
|---|---|---|---|---|
|
Adverse Events: 12-months Safety Population
Somnolence
|
6 participants
|
2 participants
|
0 participants
|
—
|
|
Adverse Events: 12-months Safety Population
Constipation
|
14 participants
|
9 participants
|
1 participants
|
—
|
|
Adverse Events: 12-months Safety Population
Dizziness
|
9 participants
|
0 participants
|
0 participants
|
—
|
|
Adverse Events: 12-months Safety Population
Nausea
|
10 participants
|
4 participants
|
1 participants
|
—
|
|
Adverse Events: 12-months Safety Population
Headache
|
7 participants
|
5 participants
|
2 participants
|
—
|
Adverse Events
Tramadol OAD 200mg
Serious events: 4 serious events
Other events: 74 other events
Deaths: 0 deaths
Tramadol OAD 300mg
Serious events: 1 serious events
Other events: 34 other events
Deaths: 0 deaths
Tramadol OAD 400mg
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Tramadol OAD 100mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tramadol OAD 200mg
n=141 participants at risk
All Patients who Received 1x200 mg Tramadol OAD Tablet daily for at Least 350 days.
OAD = Once-A-Day.
|
Tramadol OAD 300mg
n=70 participants at risk
All Patients who Received 1x300 mg Tramadol OAD Tablet daily for at Least 350 days.
OAD = Once-A-Day.
|
Tramadol OAD 400mg
n=25 participants at risk
All Patients who Received 1x400 mg Tramadol OAD Tablet daily for at Least 350 days.
OAD = Once-A-Day.
|
Tramadol OAD 100mg
n=2 participants at risk
All Patients who Received 1x100 mg Tramadol OAD Tablet daily for at Least 350 days.
OAD = Once-A-Day.
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
0.71%
1/141 • Number of events 1
|
0.00%
0/70
|
0.00%
0/25
|
0.00%
0/2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid Tumour NOS
|
0.71%
1/141 • Number of events 1
|
0.00%
0/70
|
0.00%
0/25
|
0.00%
0/2
|
|
Nervous system disorders
Cerebrovascular Disorder NOS
|
0.00%
0/141
|
1.4%
1/70 • Number of events 1
|
0.00%
0/25
|
0.00%
0/2
|
|
Vascular disorders
Essential Hypertension
|
1.4%
2/141 • Number of events 2
|
0.00%
0/70
|
4.0%
1/25 • Number of events 1
|
0.00%
0/2
|
Other adverse events
| Measure |
Tramadol OAD 200mg
n=141 participants at risk
All Patients who Received 1x200 mg Tramadol OAD Tablet daily for at Least 350 days.
OAD = Once-A-Day.
|
Tramadol OAD 300mg
n=70 participants at risk
All Patients who Received 1x300 mg Tramadol OAD Tablet daily for at Least 350 days.
OAD = Once-A-Day.
|
Tramadol OAD 400mg
n=25 participants at risk
All Patients who Received 1x400 mg Tramadol OAD Tablet daily for at Least 350 days.
OAD = Once-A-Day.
|
Tramadol OAD 100mg
n=2 participants at risk
All Patients who Received 1x100 mg Tramadol OAD Tablet daily for at Least 350 days.
OAD = Once-A-Day.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.5%
5/141 • Number of events 6
|
5.7%
4/70 • Number of events 4
|
4.0%
1/25 • Number of events 1
|
0.00%
0/2
|
|
Gastrointestinal disorders
Constipation
|
18.4%
26/141 • Number of events 62
|
22.9%
16/70 • Number of events 33
|
8.0%
2/25 • Number of events 3
|
50.0%
1/2 • Number of events 8
|
|
Gastrointestinal disorders
Diarrhoea
|
2.1%
3/141 • Number of events 3
|
2.9%
2/70 • Number of events 2
|
8.0%
2/25 • Number of events 2
|
0.00%
0/2
|
|
Nervous system disorders
Dizziness
|
18.4%
26/141 • Number of events 45
|
11.4%
8/70 • Number of events 11
|
4.0%
1/25 • Number of events 1
|
0.00%
0/2
|
|
Gastrointestinal disorders
Dry mouth
|
7.8%
11/141 • Number of events 14
|
5.7%
4/70 • Number of events 4
|
8.0%
2/25 • Number of events 2
|
0.00%
0/2
|
|
Nervous system disorders
Dysgeusia
|
0.71%
1/141 • Number of events 1
|
1.4%
1/70 • Number of events 1
|
0.00%
0/25
|
50.0%
1/2 • Number of events 1
|
|
General disorders
Fatigue
|
2.8%
4/141 • Number of events 5
|
0.00%
0/70
|
8.0%
2/25 • Number of events 2
|
0.00%
0/2
|
|
Nervous system disorders
Headache
|
9.9%
14/141 • Number of events 20
|
11.4%
8/70 • Number of events 13
|
12.0%
3/25 • Number of events 3
|
0.00%
0/2
|
|
Gastrointestinal disorders
Nausea
|
24.1%
34/141 • Number of events 61
|
14.3%
10/70 • Number of events 20
|
4.0%
1/25 • Number of events 1
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.8%
4/141 • Number of events 6
|
1.4%
1/70 • Number of events 2
|
0.00%
0/25
|
50.0%
1/2 • Number of events 2
|
|
Nervous system disorders
Somnolence
|
18.4%
26/141 • Number of events 51
|
11.4%
8/70 • Number of events 15
|
4.0%
1/25 • Number of events 1
|
50.0%
1/2 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Sweating increased
|
3.5%
5/141 • Number of events 6
|
2.9%
2/70 • Number of events 2
|
8.0%
2/25 • Number of events 2
|
0.00%
0/2
|
|
General disorders
Weakness
|
7.1%
10/141 • Number of events 16
|
8.6%
6/70 • Number of events 8
|
0.00%
0/25
|
0.00%
0/2
|
Additional Information
Director of Regulatory Affairs
Labopharm Inc.
Phone: 1 450 686 1017
Results disclosure agreements
- Principal investigator is a sponsor employee Prior to submitting results communications, the investigator shall allow Labopharm at least 30 days to review the proposed communication. If the proposed publication/disclosure risks Labopharm's ability to patent any invention related to the study, the publication or disclosure will be modified or delayed to allow Labopharm to seek patent protection. This statement does not give Labopharm any editorial rights other than to restrict the disclosure of Labopharm's confidential information.
- Publication restrictions are in place
Restriction type: OTHER