Trial Outcomes & Findings for Non-Steroidal Anti-inflammatory Drugs in Axial Spondyloarthritis (NCT NCT03473665)
NCT ID: NCT03473665
Last Updated: 2020-09-22
Results Overview
Change of pain score by numerical rating score from baseline \[scale range: 0 (better) -10 (worse)\]
TERMINATED
PHASE4
9 participants
Baseline, Week 4, and Week 6
2020-09-22
Participant Flow
This is a self-controlled study, the objective of the study is to compare the change at week 4 vs. week 6. The participants were randomized into 4 groups getting different drugs, but this is considered as one variable. The study does not intend to compare drug efficacy between arms.
Participant milestones
| Measure |
NSAIDs
Diclofenac Delayed Release Oral Tablet 75mg by mouth, every 12 hours for 6 weeks; OR Indomethacin Extended Release Oral Tablet 75mg by mouth, every 12 hours for 6 weeks; OR Meloxicam tablet 7.5mg by mouth, every 12 hours for 6 weeks; OR Celecoxib 200mg capsule by mouth, every 12 hours for 6 weeks
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
NSAIDs
n=9 Participants
Diclofenac Delayed Release Oral Tablet 75mg by mouth, every 12 hours for 6 weeks; OR Indomethacin Extended Release Oral Tablet 75mg by mouth, every 12 hours for 6 weeks; OR Meloxicam tablet 7.5mg by mouth, every 12 hours for 6 weeks; OR Celecoxib 200mg capsule by mouth, every 12 hours for 6 weeks
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=9 Participants
|
|
Pain
|
6 units on a scale
n=9 Participants
|
|
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
|
4.9 units on a scale
n=9 Participants
|
|
Bath Ankylosing Spondylitis Function Index (BASFI)
|
3.7 units on a scale
n=9 Participants
|
|
ASAS Endorsed Disease Activity Score (ASDAS)
|
3.34 units on a scale
n=9 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 4, and Week 6Population: This is a self-controlled study, the objective of the study is to compare the change at week 4 vs. week 6. The participants were randomized into 4 groups getting different drugs, but this is considered as one variable. The study does not intend to compare drug efficacy between arms.
Change of pain score by numerical rating score from baseline \[scale range: 0 (better) -10 (worse)\]
Outcome measures
| Measure |
NSAIDs x 4 Weeks
n=9 Participants
NSAIDs x 4 weeks
|
NSAIDs x 6 Weeks
n=9 Participants
NSAIDs x 6 weeks
|
|---|---|---|
|
Change of Pain Score
|
-2 units on a scale
Interval -6.0 to 2.0
|
-2 units on a scale
Interval -5.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline, Week 4, and Week 6Population: This is a self-controlled study, the objective of the study is to compare the change at week 4 vs. week 6. The participants were randomized into 4 groups getting different drugs, but this is considered as one variable. The study does not intend to compare drug efficacy between arms.
Change of BASDAI by numerical rating score from baseline \[scale range: 0 (better) -10 (worse)\]
Outcome measures
| Measure |
NSAIDs x 4 Weeks
n=9 Participants
NSAIDs x 4 weeks
|
NSAIDs x 6 Weeks
n=9 Participants
NSAIDs x 6 weeks
|
|---|---|---|
|
Change of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
|
-1.7 units on a scale
Interval -6.08 to 0.48
|
-2.09 units on a scale
Interval -5.05 to 0.48
|
SECONDARY outcome
Timeframe: Baseline, Week 4, and Week 6Population: This is a self-controlled study, the objective of the study is to compare the change at week 4 vs. week 6. The participants were randomized into 4 groups getting different drugs, but this is considered as one variable. The study does not intend to compare drug efficacy between arms.
Change of BASFI by numerical rating score from baseline \[scale range: 0 (better) -10 (worse)\]
Outcome measures
| Measure |
NSAIDs x 4 Weeks
n=9 Participants
NSAIDs x 4 weeks
|
NSAIDs x 6 Weeks
n=9 Participants
NSAIDs x 6 weeks
|
|---|---|---|
|
Change of Bath Ankylosing Spondylitis Function Index (BASFI)
|
-0.8 units on a scale
Interval -5.8 to 1.7
|
-1.2 units on a scale
Interval -4.2 to 0.4
|
SECONDARY outcome
Timeframe: Baseline, Week 4, and Week 6Population: This is a self-controlled study, the objective of the study is to compare the change at week 4 vs. week 6. The participants were randomized into 4 groups getting different drugs, but this is considered as one variable. The study does not intend to compare drug efficacy between arms.
Change of ASDAS by numerical rating score from baseline \[scale range: 0 (better) -10 (worse)\]
Outcome measures
| Measure |
NSAIDs x 4 Weeks
n=9 Participants
NSAIDs x 4 weeks
|
NSAIDs x 6 Weeks
n=9 Participants
NSAIDs x 6 weeks
|
|---|---|---|
|
Change of ASAS Endorsed Disease Activity Score (ASDAS)
|
-0.37 units on a scale
Interval -1.44 to 0.29
|
-0.84 units on a scale
Interval -1.58 to -0.01
|
SECONDARY outcome
Timeframe: Week 6Population: The participants were randomized into 4 groups getting different drugs, but this is considered as one variable. The study does not intend to compare drug efficacy between arms.
Likert Scale on whether effective or not.
Outcome measures
| Measure |
NSAIDs x 4 Weeks
n=9 Participants
NSAIDs x 4 weeks
|
NSAIDs x 6 Weeks
NSAIDs x 6 weeks
|
|---|---|---|
|
Patient Global Assessment of Response to Therapy (PGART)
Somewhat Agree
|
3 Participants
|
—
|
|
Patient Global Assessment of Response to Therapy (PGART)
Strongly Agree
|
4 Participants
|
—
|
|
Patient Global Assessment of Response to Therapy (PGART)
Strongly Disagree
|
0 Participants
|
—
|
|
Patient Global Assessment of Response to Therapy (PGART)
Somewhat Disagree
|
0 Participants
|
—
|
|
Patient Global Assessment of Response to Therapy (PGART)
Neutral
|
2 Participants
|
—
|
Adverse Events
Celecoxib
Meloxicam
Indomethacin
Diclofenac
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Celecoxib
n=3 participants at risk
Celecoxib 200mg capsule by mouth, every 12 hours for 6 weeks
|
Meloxicam
n=2 participants at risk
Meloxicam tablet 7.5mg by mouth, every 12 hours for 6 weeks
|
Indomethacin
n=2 participants at risk
Indomethacin Extended Release Oral Tablet 75mg by mouth, every 12 hours for 6 weeks
|
Diclofenac
n=2 participants at risk
Diclofenac Delayed Release Oral Tablet 75mg by mouth, every 12 hours for 6 weeks
|
|---|---|---|---|---|
|
Gastrointestinal disorders
diarrhea
|
33.3%
1/3 • Number of events 1 • 6 weeks
The participants were randomized into 4 groups getting different drugs, but this is considered as one variable. The study does not intend to compare drug efficacy between arms.
|
50.0%
1/2 • Number of events 1 • 6 weeks
The participants were randomized into 4 groups getting different drugs, but this is considered as one variable. The study does not intend to compare drug efficacy between arms.
|
50.0%
1/2 • Number of events 1 • 6 weeks
The participants were randomized into 4 groups getting different drugs, but this is considered as one variable. The study does not intend to compare drug efficacy between arms.
|
0.00%
0/2 • 6 weeks
The participants were randomized into 4 groups getting different drugs, but this is considered as one variable. The study does not intend to compare drug efficacy between arms.
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/3 • 6 weeks
The participants were randomized into 4 groups getting different drugs, but this is considered as one variable. The study does not intend to compare drug efficacy between arms.
|
0.00%
0/2 • 6 weeks
The participants were randomized into 4 groups getting different drugs, but this is considered as one variable. The study does not intend to compare drug efficacy between arms.
|
50.0%
1/2 • Number of events 1 • 6 weeks
The participants were randomized into 4 groups getting different drugs, but this is considered as one variable. The study does not intend to compare drug efficacy between arms.
|
0.00%
0/2 • 6 weeks
The participants were randomized into 4 groups getting different drugs, but this is considered as one variable. The study does not intend to compare drug efficacy between arms.
|
|
Nervous system disorders
dizziness
|
33.3%
1/3 • Number of events 1 • 6 weeks
The participants were randomized into 4 groups getting different drugs, but this is considered as one variable. The study does not intend to compare drug efficacy between arms.
|
0.00%
0/2 • 6 weeks
The participants were randomized into 4 groups getting different drugs, but this is considered as one variable. The study does not intend to compare drug efficacy between arms.
|
50.0%
1/2 • Number of events 1 • 6 weeks
The participants were randomized into 4 groups getting different drugs, but this is considered as one variable. The study does not intend to compare drug efficacy between arms.
|
0.00%
0/2 • 6 weeks
The participants were randomized into 4 groups getting different drugs, but this is considered as one variable. The study does not intend to compare drug efficacy between arms.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • 6 weeks
The participants were randomized into 4 groups getting different drugs, but this is considered as one variable. The study does not intend to compare drug efficacy between arms.
|
50.0%
1/2 • Number of events 1 • 6 weeks
The participants were randomized into 4 groups getting different drugs, but this is considered as one variable. The study does not intend to compare drug efficacy between arms.
|
0.00%
0/2 • 6 weeks
The participants were randomized into 4 groups getting different drugs, but this is considered as one variable. The study does not intend to compare drug efficacy between arms.
|
0.00%
0/2 • 6 weeks
The participants were randomized into 4 groups getting different drugs, but this is considered as one variable. The study does not intend to compare drug efficacy between arms.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
0.00%
0/3 • 6 weeks
The participants were randomized into 4 groups getting different drugs, but this is considered as one variable. The study does not intend to compare drug efficacy between arms.
|
0.00%
0/2 • 6 weeks
The participants were randomized into 4 groups getting different drugs, but this is considered as one variable. The study does not intend to compare drug efficacy between arms.
|
0.00%
0/2 • 6 weeks
The participants were randomized into 4 groups getting different drugs, but this is considered as one variable. The study does not intend to compare drug efficacy between arms.
|
50.0%
1/2 • Number of events 1 • 6 weeks
The participants were randomized into 4 groups getting different drugs, but this is considered as one variable. The study does not intend to compare drug efficacy between arms.
|
|
Renal and urinary disorders
hematuria
|
0.00%
0/3 • 6 weeks
The participants were randomized into 4 groups getting different drugs, but this is considered as one variable. The study does not intend to compare drug efficacy between arms.
|
0.00%
0/2 • 6 weeks
The participants were randomized into 4 groups getting different drugs, but this is considered as one variable. The study does not intend to compare drug efficacy between arms.
|
50.0%
1/2 • Number of events 1 • 6 weeks
The participants were randomized into 4 groups getting different drugs, but this is considered as one variable. The study does not intend to compare drug efficacy between arms.
|
0.00%
0/2 • 6 weeks
The participants were randomized into 4 groups getting different drugs, but this is considered as one variable. The study does not intend to compare drug efficacy between arms.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place