Trial Outcomes & Findings for An Open-Label Long-term Safety Study of Tramadol HCl OAD (Once A Day) 300 mg in the Treatment of Pain Due to Osteoarthritis of the Knee (NCT NCT00833911)
NCT ID: NCT00833911
Last Updated: 2012-04-30
Results Overview
Spontaneous reports of adverse events were recorded for the entire study population, the 6-months safety population and the 12-months safety population
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
392 participants
Primary outcome timeframe
6 months and 12 months
Results posted on
2012-04-30
Participant Flow
Participant milestones
| Measure |
300 mg Tramadol HCl OAD
|
|---|---|
|
Titration
STARTED
|
392
|
|
Titration
COMPLETED
|
371
|
|
Titration
NOT COMPLETED
|
21
|
|
Maintenance Phase I
STARTED
|
371
|
|
Maintenance Phase I
COMPLETED
|
273
|
|
Maintenance Phase I
NOT COMPLETED
|
98
|
|
Maintenance Phase II
STARTED
|
176
|
|
Maintenance Phase II
COMPLETED
|
166
|
|
Maintenance Phase II
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
300 mg Tramadol HCl OAD
|
|---|---|
|
Titration
Adverse Event
|
18
|
|
Titration
Withdrawal by Subject
|
3
|
|
Maintenance Phase I
Adverse Event
|
73
|
|
Maintenance Phase I
Withdrawal by Subject
|
11
|
|
Maintenance Phase I
Physician Decision
|
10
|
|
Maintenance Phase I
Lack of Efficacy
|
4
|
|
Maintenance Phase II
Adverse Event
|
6
|
|
Maintenance Phase II
Physician Decision
|
2
|
|
Maintenance Phase II
Withdrawal by Subject
|
1
|
|
Maintenance Phase II
Lack of Efficacy
|
1
|
Baseline Characteristics
An Open-Label Long-term Safety Study of Tramadol HCl OAD (Once A Day) 300 mg in the Treatment of Pain Due to Osteoarthritis of the Knee
Baseline characteristics by cohort
| Measure |
300 mg Tramadol HCl OAD
n=392 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
229 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
163 Participants
n=93 Participants
|
|
Age Continuous
|
61.4 years
STANDARD_DEVIATION 8.5 • n=93 Participants
|
|
Sex: Female, Male
Female
|
333 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 6 months and 12 monthsPopulation: All patients having taken 1 dose of 300 mg Tramadol HCl OAD at a minimum are being assessed for adverse event occurence for up to 12 months. 6-months safety: patients who completed at least 175 days on treatment. 12-months safety: patients who completed at least 350 days on treatment.
Spontaneous reports of adverse events were recorded for the entire study population, the 6-months safety population and the 12-months safety population
Outcome measures
| Measure |
All Patients With 1 Dose of 300 mg Tramadol HCl OAD Minimum
n=392 Participants
All patients in the study who took at least one dose of 300 mg Tramadol HCl OAD. Overall time frame for this population is 0-12 months.
|
6-months Safety
n=275 Participants
|
12-months Safety
n=168 Participants
|
|---|---|---|---|
|
Number of Patients Having Experienced an Adverse Event During the 6-12 Month Open-Label Safety Participation
|
346 participants
|
188 participants
|
121 participants
|
Adverse Events
All Patients With 1 Dose of 300 mg Tramadol HCl OAD Minimum
Serious events: 9 serious events
Other events: 321 other events
Deaths: 0 deaths
6-months Safety
Serious events: 1 serious events
Other events: 169 other events
Deaths: 0 deaths
12-months Safety
Serious events: 0 serious events
Other events: 101 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Patients With 1 Dose of 300 mg Tramadol HCl OAD Minimum
n=392 participants at risk
All patients in the study who took at least one dose of 300 mg Tramadol HCl OAD. Overall time frame for this population is 0-12 months.
|
6-months Safety
n=275 participants at risk
|
12-months Safety
n=168 participants at risk
|
|---|---|---|---|
|
Cardiac disorders
Acute pulmonary oedema
|
0.26%
1/392 • Number of events 1
|
0.00%
0/275
|
0.00%
0/168
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.26%
1/392 • Number of events 1
|
0.36%
1/275 • Number of events 1
|
0.00%
0/168
|
|
Vascular disorders
Cerebrovascular accident
|
0.26%
1/392 • Number of events 1
|
0.00%
0/275
|
0.00%
0/168
|
|
Surgical and medical procedures
Cholecystectomy
|
0.26%
1/392 • Number of events 1
|
0.00%
0/275
|
0.00%
0/168
|
|
Hepatobiliary disorders
Cholecystitis, Not Otherwise Specified (NOS)
|
0.26%
1/392 • Number of events 1
|
0.00%
0/275
|
0.00%
0/168
|
|
Gastrointestinal disorders
Constipation
|
0.26%
1/392 • Number of events 1
|
0.00%
0/275
|
0.00%
0/168
|
|
Metabolism and nutrition disorders
Diabetes mellitus, Not Otherwise Specified (NOS)
|
0.26%
1/392 • Number of events 1
|
0.00%
0/275
|
0.00%
0/168
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.26%
1/392 • Number of events 1
|
0.00%
0/275
|
0.00%
0/168
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis aggravated
|
0.26%
1/392 • Number of events 1
|
0.00%
0/275
|
0.00%
0/168
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.26%
1/392 • Number of events 1
|
0.00%
0/275
|
0.00%
0/168
|
|
Nervous system disorders
Paresis
|
0.26%
1/392 • Number of events 1
|
0.00%
0/275
|
0.00%
0/168
|
Other adverse events
| Measure |
All Patients With 1 Dose of 300 mg Tramadol HCl OAD Minimum
n=392 participants at risk
All patients in the study who took at least one dose of 300 mg Tramadol HCl OAD. Overall time frame for this population is 0-12 months.
|
6-months Safety
n=275 participants at risk
|
12-months Safety
n=168 participants at risk
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Anorexia
|
5.4%
21/392 • Number of events 22
|
5.5%
15/275 • Number of events 16
|
4.8%
8/168 • Number of events 8
|
|
Gastrointestinal disorders
Constipation
|
30.9%
121/392 • Number of events 155
|
26.9%
74/275 • Number of events 86
|
23.8%
40/168 • Number of events 51
|
|
Nervous system disorders
Dizziness
|
27.0%
106/392 • Number of events 134
|
10.9%
30/275 • Number of events 42
|
13.1%
22/168 • Number of events 36
|
|
General disorders
Fatigue
|
4.8%
19/392 • Number of events 27
|
5.5%
15/275 • Number of events 20
|
2.4%
4/168 • Number of events 4
|
|
Nervous system disorders
Headache
|
15.8%
62/392 • Number of events 80
|
9.1%
25/275 • Number of events 31
|
16.7%
28/168 • Number of events 42
|
|
Vascular disorders
Hypertension
|
3.8%
15/392 • Number of events 15
|
1.8%
5/275 • Number of events 5
|
6.0%
10/168 • Number of events 10
|
|
Infections and infestations
Influenza
|
4.8%
19/392 • Number of events 22
|
6.5%
18/275 • Number of events 20
|
4.2%
7/168 • Number of events 8
|
|
Infections and infestations
Nasopharyngitis
|
5.6%
22/392 • Number of events 25
|
5.8%
16/275 • Number of events 17
|
7.7%
13/168 • Number of events 15
|
|
Gastrointestinal disorders
Nausea
|
40.6%
159/392 • Number of events 233
|
22.5%
62/275 • Number of events 92
|
25.0%
42/168 • Number of events 67
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.4%
21/392 • Number of events 23
|
1.5%
4/275 • Number of events 4
|
0.60%
1/168 • Number of events 1
|
|
Nervous system disorders
Somnolence
|
25.3%
99/392 • Number of events 116
|
10.5%
29/275 • Number of events 36
|
7.7%
13/168 • Number of events 13
|
|
Skin and subcutaneous tissue disorders
Sweating increased
|
5.9%
23/392 • Number of events 25
|
6.5%
18/275 • Number of events 20
|
1.2%
2/168 • Number of events 3
|
|
Infections and infestations
Urinary tract infection
|
5.1%
20/392 • Number of events 20
|
2.5%
7/275 • Number of events 7
|
6.0%
10/168 • Number of events 10
|
|
Ear and labyrinth disorders
Vertigo
|
7.9%
31/392 • Number of events 38
|
2.9%
8/275 • Number of events 9
|
4.8%
8/168 • Number of events 11
|
|
Gastrointestinal disorders
Vomiting
|
14.0%
55/392 • Number of events 67
|
6.2%
17/275 • Number of events 24
|
7.7%
13/168 • Number of events 17
|
|
Investigations
Weight decreased
|
7.4%
29/392 • Number of events 29
|
5.8%
16/275 • Number of events 16
|
6.5%
11/168 • Number of events 11
|
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