Moderate to Severe Chronic Pain Due to Osteoarthritis of the KneePhase 2NCT01709214
Safety and Efficacy Study of GRT6005 in Patients With Osteoarthritis (OA) Knee Pain
A Phase 2 study testing Cebranopadol (GRT6005) Low-Dose Range, Cebranopadol (GRT6005) High-Dose Range and Oxycodone CR in people with Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee, run by Tris Pharma, Inc. at 83 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of GRT6005 compared to placebo in patients with moderate to severe chronic pain due to osteoarthritis (OA) of the knee. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee
- What is being tested?
- Cebranopadol (GRT6005) Low-Dose Range, Cebranopadol (GRT6005) High-Dose Range and Oxycodone CR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 619 participants
- Where
- 83 sitesUnited States
- Study dates
- 4 Dec 2012to 4 Apr 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of osteoarthritis (OA) of the knee
- OA knee pain present for at least 3 months
- OA knee pain is the predominant (ie, most painful) pain condition
- Patients require medication on at least 4 of 7 days per week to treat OA knee pain for at least 1 month.
- Dissatisfaction with current OA knee pain treatment and willingness to stop taking all pain medications except for the study drug and allowed rescue medication
- Average daily pain rating of at least 5 on a 0 to 10 point numerical rating scale during the 1 week prior to randomization
- Female patients either postmenopausal, surgically sterile or practicing a medically acceptable method of contraception
- Male patients either status post-bilateral vasectomy or using barrier contraception
Who cannot join
- Knee pain due to a disorder other than OA
- Other pain that can confound the assessment of, or contribute to, pain at the reference knee
- Surgery at the reference knee within 6 months of Screening or a history of joint replacement surgery at the reference knee
- Trauma to the reference knee within 6 months of Screening with active symptoms
- Steroid injections in the reference knee within 3 months of Screening
- Hyaluronic acid injections in the reference knee within 6 months of Screening
- Body Mass Index > 40 kg/m2
- Patient with any protocol-excluded or clinically significant medical, surgical, or medication history that would limit the patient's ability to complete or participate in this clinical trial or could confound the study assessments
Trial locations and contacts
83 sites in 1 country.
83 sites in 1 country
United States83 sites
Site 068
Albany, New York, 12208
Site 009
Albuquerque, New Mexico, 87102
Site 045
Altoona, Pennsylvania, 16602
Site 034
Anderson, South Carolina, 29621
Site 055
Austin, Texas, 78731
Site 066
Bellevue, Washington, 98007
Site 029
Bend, Oregon, 97701
Site 016
Bingham Farms, Michigan, 48025
Site 051
Birmingham, Alabama, 35209
Site 022
Birmingham, Alabama, 35216
Site 011
Bradenton, Florida, 34209
Site 093
Bristol, Tennessee, 37620
Site 049
Bryan, Texas, 77802
Site 076
Charleston, South Carolina, 29407
Site 086
Chicago, Illinois, 60612
Site 081
Chino, California, 91710
Site 079
Cincinnati, Ohio, 45219
Site 008
Cincinnati, Ohio, 45242
Site 071
Clearwater, Florida, 33761
Site 069
Cleveland, Ohio, 44122
Site 001
Columbus, Ohio, 43213
Site 038
Dallas, Texas, 75203
Site 019
Draper, Utah, 84020
Site 002
Duncansville, Pennsylvania, 16635
Site 090
Edgewater, Florida, 32132
Site 030
El Cajon, California, 92020
Site 039
Fair Oaks, California, 95628
Site 061
Fresno, California, 93726
Site 087
Grand Island, Nebraska, 68803
Site 056
Greensboro, North Carolina, 27410
Site 017
Hartsdale, New York, 10530
Site 006
High Point, North Carolina, 27262
Site 031
Huntsville, Alabama, 35801
Site 041
Indianapolis, Indiana, 46260
Site 060
Jacksonville, Florida, 32256
Site 015
Jupiter, Florida, 33458
Site 024
Las Vegas, Nevada, 89130
Site 072
Las Vegas, Nevada, 89144
Site 052
Marietta, Georgia, 30066
Site 067
Medford, Oregon, 97504
Site 013
Miami, Florida, 33144
Site 083
New Bedford, Massachusetts, 02740
Site 003
New Port Richey, Florida, 34652
Site 092
Norfolk, Virginia, 23507
Site 021
North Dartmouth, Massachusetts, 02747
Site 084
North Hollywood, California, 91606
Site 012
Ocala, Florida, 34474
Site 064
Ogden, Utah, 84405
Site 075
Oklahoma City, Oklahoma, 73103
Site 074
Omaha, Nebraska, 68144
Site 032
Orlando, Florida, 32806
Site 025
Ormond Beach, Florida, 32174
Site 058
Pembroke Pines, Florida, 33028
Site 033
Perry, Georgia, 31069
Site 005
Phoenix, Arizona, 85018
Site 018
Phoenix, Arizona, 85023
Site 070
Phoenix, Arizona, 85027
Site 091
Pinellas Park, Florida, 33781
Site 035
Portland, Oregon, 97239
Site 057
Renton, Washington, 98057
Site 080
Roseville, California, 95661
Site 004
Sacramento, California, 95821
Site 059
Salt Lake City, Utah, 84106
Site 089
San Antonio, Texas, 78209
Site 040
San Antonio, Texas, 78229
Site 044
San Diego, California, 92117
Site 007
Sarasota, Florida, 34238
Site 065
Seattle, Washington, 98122
Site 023
St Louis, Missouri, 63141
Site 073
Stockbridge, Georgia, 30281
Site 048
Toledo, Ohio, 43623
Site 088
Towson, Maryland, 21204
Site 042
Traverse City, Michigan, 49684
Site 028
Tucson, Arizona, 85712
Site 043
Tustin, California, 92780
Site 085
Valparaiso, Indiana, 46383
Site 026
Virginia Beach, Virginia, 23454
Site 010
Walnut Creek, California, 94598
Site 027
Westlake Village, California, 91361
Site 077
Wheaton, Maryland, 20902
Site 082
Wichita Falls, Texas, 76309
Site 078
Wilmington, North Carolina, 28401
Site 020
Worcester, Massachusetts, 01605
About this study
Official title: A Randomized, Double-Blind, Placebo- and Active Controlled Study to Evaluate the Safety and Efficacy of GRT6005 in Patients With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee
The purpose of this study is to evaluate the safety and efficacy of GRT6005 compared to placebo in patients with moderate to severe chronic pain due to osteoarthritis (OA) of the knee. This study includes a maximum 21 day Screening Period followed by a 15-week Double-blind Treatment Period and a 4-7 day Safety Follow-up period. Patients who are eligible for the Double-blind Treatment Period will be randomized to one of following treatment groups: GRT6005 high-dose range (400, 600 or 800 mcg), GRT6005 low-dose range (200, 300 or 400 mcg), oxycodone controlled release (CR) dose range (10, 20, 30, 40 or 50 mg) or placebo.
- Being tested
- Cebranopadol (GRT6005) Low-Dose Range, Cebranopadol (GRT6005) High-Dose Range, Placebo, Oxycodone CR
- Keywords
- Osteoarthritis, Knee, Pain, Chronic, OA, Arthritis
- Medical subject headings
- Osteoarthritis, Pain, Bronchiolitis Obliterans Syndrome, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cebranopadol (GRT6005) Low-Dose RangeDrug
Capsules
Cebranopadol (GRT6005) High-Dose RangeDrug
Capsules
PlaceboDrug
Capsules that did not contain active substance but appeared identical to the cebranopadol and oxycodone CR capsules
Oxycodone CRDrug
Capsules containing oxycodone CR 10 or 20 milligrams
| Study group | Role | What they receive |
|---|---|---|
| Cebranopadol (GRT6005) Low-Dose Range | Experimental | Once daily GRT6005, flexible dosing 200, 300 or 400 micrograms, and once daily Placebo; oral administration for 15 weeks Receives: Drug: Cebranopadol (GRT6005) Low-Dose Range; Drug: Placebo |
| Cebranopadol (GRT6005) High-Dose Range | Experimental | Once daily GRT6005, flexible dosing 400, 600 or 800 micrograms, and once daily Placebo; oral administration for 15 weeks Receives: Drug: Cebranopadol (GRT6005) High-Dose Range; Drug: Placebo |
| Placebo | Placebo comparator | Twice daily Placebo, oral administration for 15 weeks Receives: Drug: Placebo |
| Oxycodone CR | Active comparator | Twice daily Oxycodone CR, flexible dosing 10, 20, 30, 40 or 50 milligrams; oral administration for 15 weeks Receives: Drug: Oxycodone CR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the weekly average of the daily average pain rating
Measured: Baseline to end of treatment (Week 15)
Secondary outcomes (1)
Change from baseline in the physical function subscale of the Western Ontario and McMaster University Index of Osteoarthritis Questionnaire (WOMAC)
Measured: Baseline to end of treatment (Week 15)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2012 (estimated)
- Study start4 Dec 2012
- Primary completionApr 2014
- Study completion4 Apr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Chronic Pain Due to Osteoarthritis of the KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 619 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tris Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Forest Laboratories
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Grünenthal GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01709214
- Sponsor's protocol ID
- GRT-MD-101
- Status last verified
- Jul 2021
- First submitted
- 16 Oct 2012
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo- and Active Controlled Study to Evaluate the Safety and Efficacy of GRT6005 in Patients With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT01709214
- Acronym / sponsor ID
- GRT-MD-101
- Keywords
- Osteoarthritis, Knee, Pain, Chronic, OA, Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 619 participants (actual)
- Lead sponsor
- Tris Pharma, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Forest Laboratories
- Study start
- 4 Dec 2012 (actual)
- Primary completion
- Apr 2014 (actual)
- Study completion
- 4 Apr 2014 (actual)
- First posted
- 18 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and efficacy of GRT6005 compared to placebo in patients with moderate to severe chronic pain due to osteoarthritis (OA) of the knee. This study includes a maximum 21 day Screening Period followed by a 15-week Double-blind Treatment Period and a 4-7 day Safety Follow-up period. Patients who are eligible for the Double-blind Treatment Period will be randomized to one of following treatment groups: GRT6005 high-dose range (400, 600 or 800 mcg), GRT6005 low-dose range (200, 300 or 400 mcg), oxycodone controlled release (CR) dose range (10, 20, 30, 40 or 50 mg) or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cebranopadol (GRT6005) Low-Dose Range | Experimental | Drug: Cebranopadol (GRT6005) Low-Dose Range, Drug: PlaceboOnce daily GRT6005, flexible dosing 200, 300 or 400 micrograms, and once daily Placebo; oral administration for 15 weeks |
| Cebranopadol (GRT6005) High-Dose Range | Experimental | Drug: Cebranopadol (GRT6005) High-Dose Range, Drug: PlaceboOnce daily GRT6005, flexible dosing 400, 600 or 800 micrograms, and once daily Placebo; oral administration for 15 weeks |
| Placebo | Placebo comparator | Drug: PlaceboTwice daily Placebo, oral administration for 15 weeks |
| Oxycodone CR | Active comparator | Drug: Oxycodone CRTwice daily Oxycodone CR, flexible dosing 10, 20, 30, 40 or 50 milligrams; oral administration for 15 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of osteoarthritis (OA) of the knee
- OA knee pain present for at least 3 months
- OA knee pain is the predominant (ie, most painful) pain condition
- Patients require medication on at least 4 of 7 days per week to treat OA knee pain for at least 1 month.
- Dissatisfaction with current OA knee pain treatment and willingness to stop taking all pain medications except for the study drug and allowed rescue medication
Key exclusion criteria (8 listed)
- Knee pain due to a disorder other than OA
- Other pain that can confound the assessment of, or contribute to, pain at the reference knee
- Surgery at the reference knee within 6 months of Screening or a history of joint replacement surgery at the reference knee
- Trauma to the reference knee within 6 months of Screening with active symptoms
- Steroid injections in the reference knee within 3 months of Screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cebranopadol (GRT6005) Low-Dose RangeCapsules | Drug | Cebranopadol (GRT6005) Low-Dose Range |
| Cebranopadol (GRT6005) High-Dose RangeCapsules | Drug | Cebranopadol (GRT6005) High-Dose Range |
| PlaceboCapsules that did not contain active substance but appeared identical to the cebranopadol and oxycodone CR capsules | Drug | Cebranopadol (GRT6005) High-Dose Range, Cebranopadol (GRT6005) Low-Dose Range, Placebo |
| Oxycodone CRCapsules containing oxycodone CR 10 or 20 milligrams | Drug | Oxycodone CR |
Primary outcome
Change from baseline in the weekly average of the daily average pain rating
Time frame: Baseline to end of treatment (Week 15)
1 secondary outcome
Change from baseline in the physical function subscale of the Western Ontario and McMaster University Index of Osteoarthritis Questionnaire (WOMAC)
Time frame: Baseline to end of treatment (Week 15)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Grünenthal GmbH
83 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cebranopadol (GRT6005) Low-Dose Range, Cebranopadol (GRT6005) High-Dose Range and Oxycodone CR in people with Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee, run by Tris Pharma, Inc. at 83 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 83 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the weekly average of the daily average pain rating (time frame: Baseline to end of treatment (Week 15)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2021.