Trial · NCT01208207
A Two-Part 26-Week Study of Etoricoxib as Treatment for Ankylosing Spondylitis (AS) (MK-0663-108)
NCT01208207, Phase 3, Completed, Organon and Co; results first posted 2015-07-02
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Two-Part 26-Week Study of Etoricoxib as Treatment for Ankylosing Spondylitis (AS) (MK-0663-108). Trials, record NCT01208207. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01208207
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Two-Part 26-Week Study of Etoricoxib as Treatment for Ankylosing Spondylitis (AS) (MK-0663-108)
- NCT number
- NCT01208207
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,015 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Spondylitis, Ankylosing
- Interventions
Part I - etoricoxib 60 mg, Part I - etoricoxib 90 mg, Part I- naproxen 1000 mg, Part I - Placebo to naproxen 500 mg, Part II- etoricoxib 60 mg, Part II- etoricoxib 90 mg, Part II- naproxen 1000 mg, Part I - Placebo to etoricoxib 60 mg, Part I - Placebo to etoricoxib 90 mg, Part II- Placebo to etoricoxib 60 mg, Part II - Placebo to etoricoxib 90 mg, Part II- Placebo to naproxen 500 mg
- First posted
- 2010-09-23
- Last updated
- 2024-06-18
- Results first posted
- 2015-07-02
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: Etoricoxib 90 mg vs. Naproxen | Baseline and up to Week 6 | Spinal Pain Intensity is measured using a visual analog scale (VAS) from 0-100 mm with a lower value representing a better response. The time-weighted average change is calculated by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average. |
| Primary | Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: Etoricoxib 60 mg vs. Naproxen | Baseline and up to Week 6 | Spinal Pain Intensity is measured using a visual analog scale (VAS) from 0-100 mm with a lower value representing a better response. The time-weighted average change is calculated by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average. |
| Primary | Number of Participants Discontinuing Study Treatment Due to an Adverse Event | Up to 26 weeks | |
| Secondary | Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: Etoricoxib 90 mg vs. Etoricoxib 60 mg | Baseline and up to Week 6 | Spinal Pain Intensity is measured using a visual analog scale (VAS) from 0-100 mm with a lower value representing a better response. The time-weighted average change is calculated by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average. |
| Secondary | Average Change From Week 6 in the Spinal Pain Intensity Over Weeks 10 and 12 in Study Part 2: Etoricoxib 60/90 mg vs. Etoricoxib 60mg (Non-responders From Part I) | Week 6 to Week 10 and Week 12 | Spinal Pain Intensity is measured using a visual analog scale (VAS) from 0-100 mm with a lower value representing a better response. Average change from Week 6 in Spinal Pain Intensity (VAS) over Weeks 10 and 12 is calculated as the average Spinal pain Intensity (VAS) value over Weeks 10 and 12 minus the Spinal Pain Intensity (VAS) at Week 6. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: Etoricoxib 90 mg vs. Naproxen | Baseline and up to Week 6 | Per-Protocol Population - excluded participants due to important protocol deviations that may have had a substantial effect on the result of the primary efficacy endpoint. | mm VAS | LEAST_SQUARES_MEAN |
| PRIMARY | Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: Etoricoxib 60 mg vs. Naproxen | Baseline and up to Week 6 | Per-Protocol Population - excluded participants due to important protocol deviations that may have had a substantial effect on the result of the primary efficacy endpoint. | mm VAS | LEAST_SQUARES_MEAN |
| SECONDARY | Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: Etoricoxib 90 mg vs. Etoricoxib 60 mg | Baseline and up to Week 6 | Modified Intent-to-Treat (mITT) Population - the mITT population in Part I consisted of all randomized participants who received at least 1 dose of study treatment, had at least 1 measurement of interest post-randomization that was collected within 3 days of the last dose of study medication taken in Part I, and had baseline data. | mm VAS | LEAST_SQUARES_MEAN |
| SECONDARY | Average Change From Week 6 in the Spinal Pain Intensity Over Weeks 10 and 12 in Study Part 2: Etoricoxib 60/90 mg vs. Etoricoxib 60mg (Non-responders From Part I) | Week 6 to Week 10 and Week 12 | Modified Intent-to-Treat (mITT) Population - the mITT population in Part I consisted of all randomized participants who received at least 1 dose of study treatment, had at least 1 measurement of interest post-randomization that was collected within 3 days of the last dose of study medication taken in Part I, and had baseline data. | mm VAS | LEAST_SQUARES_MEAN |
| PRIMARY | Number of Participants Discontinuing Study Treatment Due to an Adverse Event | Up to 26 weeks | All Patients as Treated Population (APaT) - Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to 60 mg in Part II received 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: Etoricoxib 90 mg vs. Naproxen | Etoricoxib 90 mg | -31.23 | 95% Confidence Interval -34.70 to -27.76 | mm VAS | |
| Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: Etoricoxib 90 mg vs. Naproxen | Naproxen 1000 mg | -30.59 | 95% Confidence Interval -34.07 to -27.10 | mm VAS | |
| Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: Etoricoxib 60 mg vs. Naproxen | Etoricoxib 60 mg | -29.00 | 95% Confidence Interval -30.69 to -27.31 | mm VAS | |
| Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: Etoricoxib 60 mg vs. Naproxen | Naproxen 1000 mg | -30.59 | 95% Confidence Interval -34.07 to -27.10 | mm VAS | |
| Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: Etoricoxib 90 mg vs. Etoricoxib 60 mg | Etoricoxib 90 mg | -30.51 | 95% Confidence Interval -33.87 to -27.15 | mm VAS | |
| Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: Etoricoxib 90 mg vs. Etoricoxib 60 mg | Etoricoxib 60 mg | -28.94 | 95% Confidence Interval -30.58 to -27.29 | mm VAS | |
| Average Change From Week 6 in the Spinal Pain Intensity Over Weeks 10 and 12 in Study Part 2: Etoricoxib 60/90 mg vs. Etoricoxib 60mg (Non-responders From Part I) | Etoricoxib 60 mg/ 90 mg | -9.97 | 95% Confidence Interval -12.42 to -7.51 | mm VAS | |
| Average Change From Week 6 in the Spinal Pain Intensity Over Weeks 10 and 12 in Study Part 2: Etoricoxib 60/90 mg vs. Etoricoxib 60mg (Non-responders From Part I) | Etoricoxib 60 mg / 60 mg | -7.26 | 95% Confidence Interval -9.73 to -4.80 | mm VAS | |
| Number of Participants Discontinuing Study Treatment Due to an Adverse Event | Etoricoxib 60 mg (Part I) | 22 | Participants | ||
| Number of Participants Discontinuing Study Treatment Due to an Adverse Event | Etoricoxib 90 mg (Part I) | 2 | Participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow42
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part I | STARTED | Etoricoxib 60 mg (Part I) | 702 | |
| Part I | STARTED | Etoricoxib 90 mg (Part I) | 156 | |
| Part I | STARTED | Naproxen 1000 mg (Part I) | 157 | |
| Part I | STARTED | Etoricoxib 60 mg / 60 mg (Part II) | 0 | |
| Part I | STARTED | Etoricoxib 60 mg / 90 mg (Part II) | 0 | |
| Part I | STARTED | Etoricoxib 90 mg / 90 mg (Part II) | 0 | |
| Part I | STARTED | Naproxen 1000 mg (Part II) | 0 | |
| Part I | COMPLETED | Etoricoxib 60 mg (Part I) | 632 | |
| Part I | COMPLETED | Etoricoxib 90 mg (Part I) | 145 | |
| Part I | COMPLETED | Naproxen 1000 mg (Part I) | 142 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 participant flowAdverse events371
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain upper | Gastrointestinal disorders | Etoricoxib 60 mg / Etoricoxib 60 mg | 15 | 313 | 28 |
| other | Abdominal pain upper | Gastrointestinal disorders | Etoricoxib 60 mg / Etoricoxib 90 mg | 8 | 319 | 12 |
| other | Abdominal pain upper | Gastrointestinal disorders | Etoricoxib 90 mg / Etoricoxib 90 mg | 2 | 145 | 2 |
| other | Abdominal pain upper | Gastrointestinal disorders | Naproxen 1000 mg / Naproxen 1000 mg | 10 | 142 | 10 |
| other | Abdominal pain upper | Gastrointestinal disorders | Etoricoxib 60 mg | 3 | 70 | 6 |
| other | Abdominal pain upper | Gastrointestinal disorders | Etoricoxib 90 mg | 0 | 10 | 0 |
| other | Abdominal pain upper | Gastrointestinal disorders | Naproxen 1000 mg | 0 | 14 | 0 |
| other | Nasopharyngitis | Infections and infestations | Etoricoxib 60 mg / Etoricoxib 60 mg | 17 | 313 | 19 |
| other | Nasopharyngitis | Infections and infestations | Etoricoxib 60 mg / Etoricoxib 90 mg | 21 | 319 | 21 |
| other | Nasopharyngitis | Infections and infestations | Etoricoxib 90 mg / Etoricoxib 90 mg | 7 | 145 | 7 |
1 to 10 of 371Source ClinicalTrials.gov
See all 371 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Etoricoxib 60 mg / Etoricoxib 60 mg | ||
| Total, all-cause mortality | Etoricoxib 60 mg / Etoricoxib 90 mg | ||
| Total, all-cause mortality | Etoricoxib 90 mg / Etoricoxib 90 mg | ||
| Total, all-cause mortality | Naproxen 1000 mg / Naproxen 1000 mg | ||
| Total, all-cause mortality | Etoricoxib 60 mg | ||
| Total, all-cause mortality | Etoricoxib 90 mg | ||
| Total, all-cause mortality | Naproxen 1000 mg | ||
| Total, other adverse events | Etoricoxib 60 mg / Etoricoxib 60 mg | 55 | 313 |
| Total, other adverse events | Etoricoxib 60 mg / Etoricoxib 90 mg | 50 | 319 |
| Total, other adverse events | Etoricoxib 90 mg / Etoricoxib 90 mg | 24 | 145 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27737664 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01208207
GET https://conductscience.org/api/trials/v1/NCT01208207/flow?page=2