Trial · NCT00521989
CRx-102 Osteoarthritis Multicenter Evaluation Trial
NCT00521989, Phase 2, Terminated, Zalicus; results first posted 2014-04-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. CRx-102 Osteoarthritis Multicenter Evaluation Trial. Trials, record NCT00521989. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00521989
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- CRx-102 Osteoarthritis Multicenter Evaluation Trial
- NCT number
- NCT00521989
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 279 participants, actual
- Lead sponsor
- Zalicus
- Conditions
- Knee Osteoarthritis
- Interventions
- CRx-102 (2.7/90), Prednisolone, Placebo, CRx-102 (2.7/180), CRx-102 (2.7/360)
- First posted
- 2007-08-29
- Last updated
- 2014-04-29
- Results first posted
- 2014-04-29
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Day 98 Using the WOMAC Pain Question #1 | Baseline to Day 98 | The WOMAC Index is a validated, 24-question self-administered assessment of three dimensions of pain, stiffness, and physical function for subjects with knee or hip OA. The WOMAC pain question #1 asks subjects to "think about the pain you felt in your (study joint) caused by your arthritis during the last 48 hours when walking on a flat surface." This is a visual analog scale (VAS) where the subject indicates pain severity by making a mark through a 100 mm horizontal line with "No Pain" on the left (0 mm) and "Extreme Pain" on the right (100 mm). The distance between the left end of the scale and the subject's mark is measured in millimeters. Lower values represent a better outcome. |
| Secondary | To Assess the Efficacy of the CRx-102 Compared to Placebo on the Change From Baseline to Day 98 Using the Full WOMAC Pain, Stiffness, Physical Function Parameters, and Patient Global Assessment VAS. | Day 98 |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Day 98 Using the WOMAC Pain Question #1 | Baseline to Day 98 | ITT population | millimeters | MEAN |
| SECONDARY | To Assess the Efficacy of the CRx-102 Compared to Placebo on the Change From Baseline to Day 98 Using the Full WOMAC Pain, Stiffness, Physical Function Parameters, and Patient Global Assessment VAS. | Day 98 |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Day 98 Using the WOMAC Pain Question #1 | CRx-102 (2.7/90 mg) | -32.4 | Standard Deviation 27.07 | millimeters | |
| Change From Baseline to Day 98 Using the WOMAC Pain Question #1 | CRx-102 (2.7/180 mg) | -33.2 | Standard Deviation 32.02 | millimeters | |
| Change From Baseline to Day 98 Using the WOMAC Pain Question #1 | CRx-102 (2.7/360 mg) | -37.3 | Standard Deviation 33.07 | millimeters | |
| Change From Baseline to Day 98 Using the WOMAC Pain Question #1 | Prednisolone | -40.4 | Standard Deviation 30.04 | millimeters | |
| Change From Baseline to Day 98 Using the WOMAC Pain Question #1 | Placebo | -34.6 | Standard Deviation 27.11 | millimeters |
Source ClinicalTrials.gov
Participant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CRx-102 (2.7/90 mg) | 56 | |
| Overall Study | STARTED | CRx-102 (2.7/180 mg) | 54 | |
| Overall Study | STARTED | CRx-102 (2.7/360 mg) | 57 | |
| Overall Study | STARTED | Prednisolone | 54 | |
| Overall Study | STARTED | Placebo | 58 | |
| Overall Study | COMPLETED | CRx-102 (2.7/90 mg) | 36 | |
| Overall Study | COMPLETED | CRx-102 (2.7/180 mg) | 37 | |
| Overall Study | COMPLETED | CRx-102 (2.7/360 mg) | 41 | |
| Overall Study | COMPLETED | Prednisolone | 42 | |
| Overall Study | COMPLETED | Placebo | 35 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events60
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 | Headache | Nervous system disorders | Placebo | 10 | 58 | |
| other | Headache | Nervous system disorders | Prednisolone | 14 | 54 | |
| other | Headache | Nervous system disorders | CRx-102 (2.7/90 mg) | 16 | 56 | |
| other | Headache | Nervous system disorders | CRx-102 (2.7/180 mg) | 17 | 54 | |
| other | Headache | Nervous system disorders | CRx-102 (2.7/360 mg) | 28 | 57 | |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 3 | 58 | |
| other | Diarrhea | Gastrointestinal disorders | Prednisolone | 4 | 54 | |
| other | Diarrhea | Gastrointestinal disorders | CRx-102 (2.7/90 mg) | 2 | 56 | |
| other | Diarrhea | Gastrointestinal disorders | CRx-102 (2.7/180 mg) | 4 | 54 | |
| other | Diarrhea | Gastrointestinal disorders | CRx-102 (2.7/360 mg) | 3 | 57 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Prednisolone | ||
| Total, all-cause mortality | CRx-102 (2.7/90 mg) | ||
| Total, all-cause mortality | CRx-102 (2.7/180 mg) | ||
| Total, all-cause mortality | CRx-102 (2.7/360 mg) | ||
| Total, other adverse events | Placebo | 19 | 58 |
| Total, other adverse events | Prednisolone | 26 | 54 |
| Total, other adverse events | CRx-102 (2.7/90 mg) | 29 | 56 |
| Total, other adverse events | CRx-102 (2.7/180 mg) | 29 | 54 |
| Total, other adverse events | CRx-102 (2.7/360 mg) | 40 | 57 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT00521989
GET https://conductscience.org/api/trials/v1/NCT00521989/events?page=2