Not provided
Not provided
Not provided
Not provided
Not provided
Slow recruitment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a 6-week randomized, double-blind trial of 4 different non-steroidal anti-inflammatory drugs in patients with axial spondyloarthritis to compare the change of pain score from baseline at 4 weeks to the change of pain score from baseline at 6 weeks.
Patients with ankylosing spondylitis or axial spondyloarthritis who fulfills the inclusion and exclusion criteria will be randomized into one of the four arms after an initial one week washout period, including: 1) indomethacin 75mg every 12 hours (Q12H); 2) diclofenac 75mg Q12H; 3) meloxicam 7.5mg Q12H; 4) celecoxib 200mg Q12H. The treatment length will be 6 weeks. Primary outcome is the change of pain score from baseline to week 4 and to week 6.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indomethacin | Active Comparator | Indomethacin Extended Release Oral Tablet 75mg by mouth, every 12 hours for 6 weeks |
|
| Diclofenac | Active Comparator | Diclofenac Delayed Release Oral Tablet 75mg by mouth, every 12 hours for 6 weeks |
|
| Meloxicam | Active Comparator | Meloxicam tablet 7.5mg by mouth, every 12 hours for 6 weeks |
|
| Celecoxib | Active Comparator | Celecoxib 200mg capsule by mouth, every 12 hours for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indomethacin | Drug | Indomethacin Extended Release Oral Tablet 75mg every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of Pain Score | Change of pain score by numerical rating score from baseline [scale range: 0 (better) -10 (worse)] | Baseline, Week 4, and Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | Change of BASDAI by numerical rating score from baseline [scale range: 0 (better) -10 (worse)] | Baseline, Week 4, and Week 6 |
| Change of Bath Ankylosing Spondylitis Function Index (BASFI) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Use of low-dose of aspirin (<100mg daily) is allowed in the study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Runsheng Wang, MD, MHS | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center | New York | New York | 10032 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change of Pain Score | Change of pain score by numerical rating score from baseline [scale range: 0 (better) -10 (worse)] | 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. | Posted | Median | Full Range | units on a scale | Baseline, Week 4, and Week 6 |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Celecoxib | Celecoxib 200mg capsule by mouth, every 12 hours for 6 weeks | 0 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Runsheng Wang | Columbia University | 212-305-4308 | rw2646@cumc.columbia.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 18, 2018 | Jul 30, 2020 | Prot_SAP_002.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| D000089183 | Axial Spondyloarthritis |
| D025241 | Spondylarthritis |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D004008 | Diclofenac |
| D003606 | Dacarbazine |
| D000077239 | Meloxicam |
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Diclofenac | Drug | Diclofenac Delayed Release Oral Tablet 25mg tablets x 3 tablets every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks |
|
|
| Meloxicam | Drug | meloxicam 7.5mg tablets every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks |
|
|
| Celecoxib | Drug | Celecoxib 200mg capsule every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks |
|
|
Change of BASFI by numerical rating score from baseline [scale range: 0 (better) -10 (worse)] |
| Baseline, Week 4, and Week 6 |
| Change of ASAS Endorsed Disease Activity Score (ASDAS) | Change of ASDAS by numerical rating score from baseline [scale range: 0 (better) -10 (worse)] | Baseline, Week 4, and Week 6 |
| Patient Global Assessment of Response to Therapy (PGART) | Likert Scale on whether effective or not. | Week 6 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Pain | Pain score by numerical rating score from baseline [scale range: 0 (better) -10 (worse)] | Median | Full Range | units on a scale |
|
| Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | BASDAI by numerical rating score from baseline [scale range: 0 (better) -10 (worse)] | Median | Full Range | units on a scale |
|
| Bath Ankylosing Spondylitis Function Index (BASFI) | BASFI by numerical rating score from baseline [scale range: 0 (better) -10 (worse)] | Median | Full Range | units on a scale |
|
| ASAS Endorsed Disease Activity Score (ASDAS) | Median | Full Range | units on a scale |
|
|
|
| Secondary | Change of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | Change of BASDAI by numerical rating score from baseline [scale range: 0 (better) -10 (worse)] | 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. | Posted | Median | Full Range | units on a scale | Baseline, Week 4, and Week 6 |
|
|
|
| Secondary | Change of Bath Ankylosing Spondylitis Function Index (BASFI) | Change of BASFI by numerical rating score from baseline [scale range: 0 (better) -10 (worse)] | 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. | Posted | Median | Full Range | units on a scale | Baseline, Week 4, and Week 6 |
|
|
|
| Secondary | Change of ASAS Endorsed Disease Activity Score (ASDAS) | Change of ASDAS by numerical rating score from baseline [scale range: 0 (better) -10 (worse)] | 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. | Posted | Median | Full Range | units on a scale | Baseline, Week 4, and Week 6 |
|
|
|
| Secondary | Patient Global Assessment of Response to Therapy (PGART) | Likert Scale on whether effective or not. | 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. | Posted | Count of Participants | Participants | Week 6 |
|
|
|
| 3 |
| 0 |
| 3 |
| 1 |
| 3 |
| EG001 | Meloxicam | Meloxicam tablet 7.5mg by mouth, every 12 hours for 6 weeks | 0 | 2 | 0 | 2 | 1 | 2 |
| EG002 | Indomethacin | Indomethacin Extended Release Oral Tablet 75mg by mouth, every 12 hours for 6 weeks | 0 | 2 | 0 | 2 | 2 | 2 |
| EG003 | Diclofenac | Diclofenac Delayed Release Oral Tablet 75mg by mouth, every 12 hours for 6 weeks | 0 | 2 | 0 | 2 | 1 | 2 |
| constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| hematuria | Renal and urinary disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D009140 |
| Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D014226 | Triazenes |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D013844 | Thiazoles |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D011720 | Pyrazoles |
| Somewhat Agree |
|
| Strongly Agree |
|