Trial · NCT02944448
A Study Evaluating Pain Relief and Safety of Orally Administered CR845 in Patients With Osteoarthritis of Hip or Knee
NCT02944448, Phase 2, Completed, Cara Therapeutics, Inc.; results first posted 2020-10-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Evaluating Pain Relief and Safety of Orally Administered CR845 in Patients With Osteoarthritis of Hip or Knee. Trials, record NCT02944448. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02944448
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Evaluating Pain Relief and Safety of Orally Administered CR845 in Patients With Osteoarthritis of Hip or Knee
- NCT number
- NCT02944448
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 761 participants, actual
- Lead sponsor
- Cara Therapeutics, Inc.
- Conditions
- Osteoarthritis, Hip, Osteoarthritis, Knee, Arthritis, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases
- Interventions
- CR845 tablet 1 mg, CR845 tablet 2.5 mg, CR845 tablet 5 mg, Placebo tablet
- First posted
- 2016-10-25
- Last updated
- 2020-10-20
- Results first posted
- 2020-10-20
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline at Week 8 With Respect to the Weekly Mean of the Daily 24-hour Pain Intensity for the Index Joint as Measured by the Numeric Rating Scale (NRS). | Baseline, Week 8 | 11-point NRS scale where 0 = no pain, and 10= pain as bad as you can imagine |
| Secondary | Change From Baseline in the Western Ontario & McMaster Osteoarthritis (WOMAC) Index Total Score at Week 8 | Baseline, Week 8 | The WOMAC Index is a self-administered assessment used to measure pain, stiffness, and physical function in patients with osteoarthritis. The WOMAC Index contains 24 questions across 3 different sub-scales (pain, stiffness, and function) all with scoring 0-10 (0 = No Pain/Stiffness/Difficulty, 10 = Extreme Pain/Stiffness/Difficulty). Each WOMAC Index Subscale score (Pain/Stiffness/Function) is calculated as the sum of all scores within that subscale. The pain subscale consists of five scores from 0-10, 0 is no pain 10 is extreme pain possible for a range of 0 - 50 points. The stiffness subscale consists of two scores from 0-10, 0 is no stiffness 10 is extreme stiffness possible for a range of 0 - 20 points. The function subscale consists of 17 scores from 0-10, 0 is no difficulty and 10 is extreme difficulty, for a range of 0 - 170 points. The WOMAC Index Total Score is calculated as the sum of all 24 scores (range of 0-240). |
| Secondary | Change From Baseline in the WOMAC Pain Intensity Sub-scale Score at Week 8 | Baseline, Week 8 | The pain subscale consists of five scores from 0-10, 0 is no pain 10 is extreme pain possible for a range of 0 - 50 points. |
| Secondary | Change From Baseline in the WOMAC Stiffness Sub-scale Score at Week 8 | Baseline, Week 8 | The stiffness subscale consists of two scores from 0-10, 0 is no stiffness 10 is extreme stiffness possible for a range of 0 - 20 points. |
| Secondary | Change From Baseline in the WOMAC Function Sub-scale Score at Week 8 | Baseline, Week 8 | The function subscale consists of 17 scores from 0-10, 0 is no difficulty and 10 is extreme difficulty, for a range of 0 - 170 points. |
| Secondary | Proportion of Patients With at Least 30% Improvement From Baseline in the Weekly Mean Pain Intensity at Week 8 | Week 8 | A patient's pain response to treatment is defined as the percent improvement from baseline with respect to the weekly mean of "average pain in the last 24 hours" pain score during the last week of the Maintenance Treatment Period (Week 8) . If a patient's mean weekly pain score during the last week of the Maintenance Treatment Period is greater than the baseline score (i.e., the patient has an increase in pain compared to baseline), his/her response to treatment will be assigned a value of 0 (i.e. the patient will be considered a non-responder). Patients who discontinue study drug early will be considered non-responders to treatment and will be assigned a pain response of 0. The percentage of subjects achieving levels of treatment response 10% to 100% by 10% increments as defined above will be calculated with 30% of key interest as it has been shown to represent a clinically important improvement in pain. |
| Secondary | Proportion of Patients With at Least 50% Improvement From Baseline in the Weekly Mean Pain Intensity at Week 8 | Week 8 | A patient's pain response to treatment is defined as the percent improvement from baseline with respect to the weekly mean of "average pain in the last 24 hours" pain score during the last week of the Maintenance Treatment Period (Week 8) . If a patient's mean weekly pain score during the last week of the Maintenance Treatment Period is greater than the baseline score (i.e., the patient has an increase in pain compared to baseline), his/her response to treatment will be assigned a value of 0 (i.e. the patient will be considered a non-responder). Patients who discontinue study drug early will be considered non-responders to treatment and will be assigned a pain response of 0. The percentage of subjects achieving levels of treatment response 10% to 100% by 10% increments as defined above will be calculated with 30% of key interest as it has been shown to represent a clinically important improvement in pain. |
| Secondary | Proportion of Patients Whose OA Pain Was "Very Much Improved" or "Much Improved" as Indicated by Patient Global Impression of Change (PGIC) Score at Week 8 | Week 8 | The PGIC is a self-administered instrument that measures the patient's overall impression of his/her OA on a 7-point scale where 1 = "Very much improved" and 7 = "Very much worse". |
| Secondary | Average Daily Number of Acetaminophen Tablets Used During Entire Study | Week 8 | The average daily number of acetaminophen tablets used during the study will be calculated using data recorded in the patient diary as the sum of the total number of tablets used divided by the length of exposure (in days). The supplemental pain medication for OA will be grouped categorically into the following classes: (1) no supplemental acetaminophen tablets, (2) 0 to ≤ 0.5 tablets, (3) \> 0.5 to ≤ 1.0 tablets, (4) \> 1.0 to ≤ 2.0 tablets, and (5) \> 2.0 tablets. |
| Secondary | Proportion of Patients Withdrawing From Treatment Due to Lack of Analgesic Efficacy | Week 8 |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline at Week 8 With Respect to the Weekly Mean of the Daily 24-hour Pain Intensity for the Index Joint as Measured by the Numeric Rating Scale (NRS). | Baseline, Week 8 | score on a scale | MEAN | |
| SECONDARY | Change From Baseline in the Western Ontario & McMaster Osteoarthritis (WOMAC) Index Total Score at Week 8 | Baseline, Week 8 | score on a scale | MEAN | |
| SECONDARY | Change From Baseline in the WOMAC Pain Intensity Sub-scale Score at Week 8 | Baseline, Week 8 | score on a scale | MEAN | |
| SECONDARY | Change From Baseline in the WOMAC Stiffness Sub-scale Score at Week 8 | Baseline, Week 8 | score on a scale | MEAN | |
| SECONDARY | Change From Baseline in the WOMAC Function Sub-scale Score at Week 8 | Baseline, Week 8 | score on a scale | MEAN | |
| SECONDARY | Proportion of Patients With at Least 30% Improvement From Baseline in the Weekly Mean Pain Intensity at Week 8 | Week 8 | percentage of patients | NUMBER | |
| SECONDARY | Proportion of Patients With at Least 50% Improvement From Baseline in the Weekly Mean Pain Intensity at Week 8 | Week 8 | percentage of patients | NUMBER | |
| SECONDARY | Proportion of Patients Whose OA Pain Was Very Much Improved or Much Improved as Indicated by Patient Global Impression of Change (PGIC) Score at Week 8 | Week 8 | percentage of patients | NUMBER | |
| SECONDARY | Average Daily Number of Acetaminophen Tablets Used During Entire Study | Week 8 | Tablets | MEDIAN | |
| SECONDARY | Proportion of Patients Withdrawing From Treatment Due to Lack of Analgesic Efficacy | Week 8 | percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline at Week 8 With Respect to the Weekly Mean of the Daily 24-hour Pain Intensity for the Index Joint as Measured by the Numeric Rating Scale (NRS). | CR845 Tablet | -2.3 | Standard Error 0.14 | score on a scale | |
| Change From Baseline at Week 8 With Respect to the Weekly Mean of the Daily 24-hour Pain Intensity for the Index Joint as Measured by the Numeric Rating Scale (NRS). | Placebo Tablet | -2.4 | Standard Error 0.19 | score on a scale | |
| Change From Baseline in the Western Ontario & McMaster Osteoarthritis (WOMAC) Index Total Score at Week 8 | CR845 Tablet | -62.4 | Standard Error 3.28 | score on a scale | |
| Change From Baseline in the Western Ontario & McMaster Osteoarthritis (WOMAC) Index Total Score at Week 8 | Placebo Tablet | -59.7 | Standard Error 4.34 | score on a scale | |
| Change From Baseline in the WOMAC Pain Intensity Sub-scale Score at Week 8 | CR845 Tablet | -13.5 | Standard Error 0.70 | score on a scale | |
| Change From Baseline in the WOMAC Pain Intensity Sub-scale Score at Week 8 | Placebo Tablet | -12.7 | Standard Error 0.92 | score on a scale | |
| Change From Baseline in the WOMAC Stiffness Sub-scale Score at Week 8 | CR845 Tablet | -5.7 | Standard Error 0.29 | score on a scale | |
| Change From Baseline in the WOMAC Stiffness Sub-scale Score at Week 8 | Placebo Tablet | -5.6 | Standard Error 0.38 | score on a scale | |
| Change From Baseline in the WOMAC Function Sub-scale Score at Week 8 | CR845 Tablet | -43.1 | Standard Error 2.34 | score on a scale | |
| Change From Baseline in the WOMAC Function Sub-scale Score at Week 8 | Placebo Tablet | -41.5 | Standard Error 3.10 | score on a scale |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CR845 Tablet | 316 | |
| Overall Study | STARTED | Placebo Tablet | 160 | |
| Overall Study | COMPLETED | CR845 Tablet | 227 | |
| Overall Study | COMPLETED | Placebo Tablet | 136 | |
| Overall Study | NOT COMPLETED | CR845 Tablet | 89 | |
| Overall Study | NOT COMPLETED | Placebo Tablet | 24 |
Source ClinicalTrials.gov
Adverse events40
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 | Constipation | Gastrointestinal disorders | CR845 Tablet | 42 | 316 | |
| other | Constipation | Gastrointestinal disorders | Placebo Tablet | 3 | 160 | |
| other | Dizziness | Nervous system disorders | CR845 Tablet | 26 | 316 | |
| other | Dizziness | Nervous system disorders | Placebo Tablet | 3 | 160 | |
| other | Headache | Nervous system disorders | CR845 Tablet | 18 | 316 | |
| other | Headache | Nervous system disorders | Placebo Tablet | 9 | 160 | |
| other | Dry mouth | Gastrointestinal disorders | CR845 Tablet | 18 | 316 | |
| other | Dry mouth | Gastrointestinal disorders | Placebo Tablet | 3 | 160 | |
| serious | Gastrooesophageal reflux disease | Gastrointestinal disorders | CR845 Tablet | 1 | 316 | |
| serious | Gastrooesophageal reflux disease | Gastrointestinal disorders | Placebo Tablet | 0 | 160 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CR845 Tablet | 0 | 316 |
| Total, all-cause mortality | Placebo Tablet | 0 | 160 |
| Total, other adverse events | CR845 Tablet | 82 | 316 |
| Total, other adverse events | Placebo Tablet | 17 | 160 |
| Total, serious adverse events | CR845 Tablet | 9 | 316 |
| Total, serious adverse events | Placebo Tablet | 1 | 160 |
Source ClinicalTrials.gov
Papers0
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| CR845 Tablet vs Placebo Tablet: deaths from any cause | Trial comparisons |
| CR845 Tablet vs Placebo Tablet: serious adverse events | Trial comparisons |
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/NCT02944448
GET https://conductscience.org/api/trials/v1/NCT02944448/events?page=2