Trial Outcomes & Findings for Trial Evaluating Devil's Claw for the Treatment of Hip and Knee Osteoarthritis (NCT NCT00295490)
NCT ID: NCT00295490
Last Updated: 2011-09-12
Results Overview
WOMAC is a disease specific outcome measure for osteoarthritis. It has three subscales assessing pain (5 questions), stiffness (2 questions) and function (15 questions). together the subscales give an overall total score ranging from 0 (worst) to 100 (best; an increase in total score indicates an improvement in health. THe outcome was measured at baseline, week 8 and week 16. In this study the primary outcome was the reduction in WOMAC total score from baseline to the end of treatment at week 16.
TERMINATED
PHASE2
67 participants
Baseline, week 8 and week 16
2011-09-12
Participant Flow
Recruited during 2004 to 2007 Recruitment location: From GP clinics and from adverts in the media
Patients attended screening clinic to confirm diagnosis of osteoarthritis of the knee (grade 2-4) by clinical examination and X ray and ensure other entry criteria met i.e.baseline pain (at least 20mm on 100mm scale over 6 of 7 days between screening and baseline)and exclude any other condition causing knee pain.
Participant milestones
| Measure |
240mg Devil Claw
Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
|
960mg/d Devil Claw
total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
|
1,920mg/d Devil Claw
total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
|
Placebo
total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
19
|
16
|
17
|
|
Overall Study
COMPLETED
|
14
|
15
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
4
|
5
|
Reasons for withdrawal
| Measure |
240mg Devil Claw
Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
|
960mg/d Devil Claw
total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
|
1,920mg/d Devil Claw
total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
|
Placebo
total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
|
|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
0
|
3
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
|
Overall Study
Other
|
0
|
2
|
0
|
1
|
Baseline Characteristics
Trial Evaluating Devil's Claw for the Treatment of Hip and Knee Osteoarthritis
Baseline characteristics by cohort
| Measure |
240mg Devil Claw
n=15 Participants
Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
|
960mg/d Devil Claw
n=19 Participants
total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
|
1,920mg/d Devil Claw
n=16 Participants
total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
|
Placebo
n=17 Participants
total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
|
Total
n=67 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
|
6 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Age Continuous
|
65.2 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
59.6 years
STANDARD_DEVIATION 6.9 • n=7 Participants
|
59.8 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
63.2 years
STANDARD_DEVIATION 8.6 • n=4 Participants
|
61.8 years
STANDARD_DEVIATION 9.1 • n=21 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Region of Enrollment
United Kingdom
|
15 participants
n=5 Participants
|
19 participants
n=7 Participants
|
16 participants
n=5 Participants
|
17 participants
n=4 Participants
|
67 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, week 8 and week 16Population: Zero participants were analysed as the study was terminated prematurely.
WOMAC is a disease specific outcome measure for osteoarthritis. It has three subscales assessing pain (5 questions), stiffness (2 questions) and function (15 questions). together the subscales give an overall total score ranging from 0 (worst) to 100 (best; an increase in total score indicates an improvement in health. THe outcome was measured at baseline, week 8 and week 16. In this study the primary outcome was the reduction in WOMAC total score from baseline to the end of treatment at week 16.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, week 8 and week 16Population: Zero participants were analysed as the study was terminated prematurely.
Subscale assessed by 100mm VAS based on five questions addressing pain in osteoarthritis using the terminators no pain (0mm) to extreme pain (100mm). a higher score therefore indicates more severe pain. This outcome was recorded at baseline, week 8 and week 16 (end of treatment). The outcome for this study was reported as the change in WOMAC pain score from baseline to end of treatment at week 16.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, 8 and 16 weeksPopulation: Zero participants were analysed as the study was terminated prematurely
Subscale assessed by 100mm VAS based on twelve questions addressing disability in osteoarthritis with a higher score indicating worse symptoms. The VAS used terminators of no disability (0mm) to extreme disability (100mm). The measure was recorded at baseline, week 8 and week 16. We reported the outcome as the change from baseline to end of treatment at week 16.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, week 8 and week 16Population: Zero participants were analysed as the study was terminated prematurely.
Subscale assessed by 100mm VAS based on two questions addressing stiffness in osteoarthritis;a higher score indicating worse symptoms. The VAS used terminators of no stiffness (0mm) to extreme stiffness (100mm). The measure was recorded at baseline, week 8 and week 16. We reported the outcome as the change from baseline to end of treatment at week 16.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, week 8 and week 16Population: Zero participants were analysed as the study was terminated prematurely.
Quality of Life assessment containing 8 scales clustered into 2 summary scales: physical health and mental health. Each question is scored out from 0 (indicating worst health) to 100 (indicating best health). Mean scores for the 8 scales (total scores/no questions completed) are calculated to give a total score for each of the two summary scales between 0 (worst health) and 100 (best health). SF36 was recorded at baseline, week 8 and at the end of treatment at week 16. we reported the change from baseline to end of treatment as the outcome.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, week 8 and week 16Population: Zero participants were analysed as the study was terminated prematurely
To assess changes in the subject's well-being based on 7 point likert scale ranging from very poor (0 point) to very good (7 point). Outcome was recorded at baseline, week 8 and end of treatment at week 16. We reported outcome as the change in patient global assessment from baseline to end of treatment at week 16.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: four monthlyPopulation: Zero participants were analysed as the study was terminated prematurely
Questionnaire to assess changes in attitudes and health beliefs to CAM.the questionnaire as 17 questions, each scored on a 7 point likert scale from strongly disagree to strongly agree; a higher score indicates stronger belief in the measure. Minimum score 17, maximum score 119
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and weeks 2,4,6,8,12 and 16Population: Zero participants were analysed as the study was terminated prematurely
To identify Group differences between the number of adverse event recorded by patient for both serious and non serious adverse events, as well as events considered being attributable to the study medication.
Outcome measures
Outcome data not reported
Adverse Events
240mg Devil Claw
960mg/d Devil Claw
1,920mg/d Devil Claw
Placebo
Serious adverse events
| Measure |
240mg Devil Claw
n=15 participants at risk
Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
|
960mg/d Devil Claw
n=19 participants at risk
total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
|
1,920mg/d Devil Claw
n=16 participants at risk
total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
|
Placebo
n=17 participants at risk
total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
|
|---|---|---|---|---|
|
Eye disorders
Transient blindness
|
0.00%
0/15 • Twenty week period
|
5.3%
1/19 • Number of events 1 • Twenty week period
|
0.00%
0/16 • Twenty week period
|
0.00%
0/17 • Twenty week period
|
Other adverse events
| Measure |
240mg Devil Claw
n=15 participants at risk
Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
|
960mg/d Devil Claw
n=19 participants at risk
total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
|
1,920mg/d Devil Claw
n=16 participants at risk
total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
|
Placebo
n=17 participants at risk
total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
80.0%
12/15 • Number of events 12 • Twenty week period
|
57.9%
11/19 • Number of events 11 • Twenty week period
|
56.2%
9/16 • Number of events 9 • Twenty week period
|
64.7%
11/17 • Number of events 11 • Twenty week period
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
40.0%
6/15 • Number of events 6 • Twenty week period
|
36.8%
7/19 • Number of events 7 • Twenty week period
|
12.5%
2/16 • Number of events 2 • Twenty week period
|
11.8%
2/17 • Number of events 2 • Twenty week period
|
|
General disorders
Headache
|
33.3%
5/15 • Number of events 5 • Twenty week period
|
26.3%
5/19 • Number of events 5 • Twenty week period
|
18.8%
3/16 • Number of events 3 • Twenty week period
|
11.8%
2/17 • Number of events 2 • Twenty week period
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.3%
2/15 • Number of events 2 • Twenty week period
|
10.5%
2/19 • Number of events 2 • Twenty week period
|
18.8%
3/16 • Number of events 3 • Twenty week period
|
17.6%
3/17 • Number of events 3 • Twenty week period
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
3/15 • Number of events 3 • Twenty week period
|
21.1%
4/19 • Number of events 4 • Twenty week period
|
6.2%
1/16 • Number of events 1 • Twenty week period
|
5.9%
1/17 • Number of events 1 • Twenty week period
|
|
General disorders
Fatigue
|
6.7%
1/15 • Number of events 1 • Twenty week period
|
21.1%
4/19 • Number of events 4 • Twenty week period
|
6.2%
1/16 • Number of events 1 • Twenty week period
|
11.8%
2/17 • Number of events 2 • Twenty week period
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/15 • Twenty week period
|
21.1%
4/19 • Number of events 4 • Twenty week period
|
12.5%
2/16 • Number of events 2 • Twenty week period
|
5.9%
1/17 • Number of events 1 • Twenty week period
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place