Assessment of GRT6005 in Painful Osteoarthritis of the Knee
This study has been completed.
Sponsor:
Grünenthal GmbH
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Grünenthal GmbH
ClinicalTrials.gov Identifier:
NCT01357837
First received: May 19, 2011
Last updated: January 22, 2013
Last verified: January 2013
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Purpose
The purpose of the trial is to determine whether GRT6005 is effective in patients with pain due to osteoarthritis of the knee.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis of the Knee |
Drug: Matching Placebo Drug: GRT6005 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized 4 Week Phase IIa Trial Evaluating the Efficacy, Safety, and Tolerability of GRT6005, a New Centrally Acting Analgesic, in Subjects With Moderate to Severe Pain Due to Osteoarthritis (OA) of the Knee |
Resource links provided by NLM:
Further study details as provided by Grünenthal GmbH:
Primary Outcome Measures:
- Change from baseline in the pain intensity scores during the last week of the 4-week treatment period. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from baseline in the Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee Over the 4 week treatment period. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Change from baseline in quality of health as measured by Short Form-12 Health Survey [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Response measured in percentage change of pain intensity since baseline. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Leeds Sleep Evaluation Questionnaire to quantify subjective impressions of sleep and waking. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Patient's Global Impression of Change (PGIC). [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Clinician's Global Impression of Change (CGIC). [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Weekly current pain intensity changes from baseline. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Rescue medication use [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Quality of Life EuroQoL-5 Dimension score, change from baseline. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Clinical Opioid Withdrawal Scale [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
- Plasma concentration [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Discontinuation from study due to treatment related adverse events [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
- Time to withdrawal from study [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 207 |
| Study Start Date: | May 2011 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Matching Placebo
Once daily oral administration of matching placebo for 4 weeks.
|
Drug: Matching Placebo
2 capsules of matching placebo once a day, in the morning, for a total of 28 days
|
|
Experimental: 75 µg GRT6005
Once daily oral administration of GRT6005 for 4 weeks.
|
Drug: GRT6005
2 capsules containing a total of 75 µg GRT6005 once a day, in the morning, for a total of 28 days
|
|
Experimental: 200 µg GRT6005
Once daily oral administration of GRT6005 for 4 weeks.
|
Drug: GRT6005
2 capsules containing a total of 200 µg GRT6005 once a day, in the morning, for a total of 28 days
|
|
Experimental: 400 µg GRT6005
Once daily oral administration of GRT6005 for 4 weeks.
|
Drug: GRT6005
2 capsules containing a total of 400 µg GRT6005 once a day, in the morning, for a total of 28 days
|
Detailed Description:
The purpose of this study is to evaluate the safety, tolerability and efficacy of 3 doses of GRT6005 taken once daily for 4 weeks in outpatients with moderate-to-severe painful osteoarthritis of the knee.
Eligibility| Ages Eligible for Study: | 40 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- painful Osteoarthritis of the knee based on American College of Rheumatology Criteria
- signed informed consent
- on stable analgesic medications for painful osteoarthritis with regular analgesic intake for at least 3 months
- pain intensity score of 4 or greater on the 11-point numeric rating scale (where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine").
Exclusion Criteria:
- Substance Abuse
- Significant cardiac disease
- Presence of risk factors for Torsades de Pointes and chronic severe cardiac disease
- History of seizure disorder
- Chronic gastrointestinal disease
- Conditions that contribute and confound to the assessment of pain
- Surgery or painful procedure during or within 3 months of enrollment
- Cancer
- Subjects with impaired renal function
- Subjects with impaired hepatic function
- Female subjects who are breastfeeding
- History of chronic hepatitis B or C or human immunodeficiency virus infection, or presence of acute hepatitis A, B, or C within the past 3 months.
- Clinically relevant history of hypersensitivity or allergy to paracetamol, opioids or the excipients.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01357837
Locations
| Austria | |
| Site 3604 | |
| Linz, Austria, 4021 | |
| Site 3605 | |
| Senftenberg, Austria, 3541 | |
| Site 3601 | |
| Wien, Austria, 1130 | |
| Site 3602 | |
| Wien, Austria, 1100 | |
| Site 3603 | |
| Wien, Austria, 1090 | |
| Poland | |
| Site 3203 | |
| Bialystok, Poland, 15-337 | |
| Site 3202 | |
| Elblag, Poland, 82-300 | |
| Site 3208 | |
| Gdynia, Poland, 81-834 | |
| Site 3206 | |
| Krakow, Poland, 30-349 | |
| Site 3207 | |
| Lublin, Poland, 20-605 | |
| Site 3210 | |
| Szczecin, Poland, 71-252 | |
| Site 3201 | |
| Torun, Poland, 87-100 | |
| Site 3204 | |
| Warsawa, Poland | |
| Site 3211 | |
| Warszawa, Poland, 02-730 | |
| Site 3213 | |
| Wloszczowa, Poland, 29-100 | |
| Site 3205 | |
| Wroclaw, Poland, 50-088 | |
| Spain | |
| Site 3302 | |
| Barcelona, Spain, 08034 | |
| Site 3305 | |
| Barcelona, Spain, 08028 | |
| Site 3303 | |
| Coruna, Spain, 15006 | |
| Site 3312 | |
| Málaga, Spain, 29009 | |
| Site 3308 | |
| Mérida.Badajoz., Spain, 06800 | |
| Site 3310 | |
| Oviedo, Spain, 33009 | |
| Site 3311 | |
| Petrer (Alicante), Spain, 03610 | |
| Site 3304 | |
| Santiago de Compostela, Spain, 15705 | |
| Site 3306 | |
| Sevilla, Spain, 41009 | |
| Site 3313 | |
| Torrelavega (Cantabria), Spain, 39300 | |
Sponsors and Collaborators
Grünenthal GmbH
Forest Laboratories
Investigators
| Principal Investigator: | Jacek Olas, MD | Specjalistyczne Centrum Medyczne NZOZ NOWOMED, |
More Information
No publications provided
| Responsible Party: | Grünenthal GmbH |
| ClinicalTrials.gov Identifier: | NCT01357837 History of Changes |
| Other Study ID Numbers: | 116918, 2010-022556-23 |
| Study First Received: | May 19, 2011 |
| Last Updated: | January 22, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Spain: Spanish Agency of Medicines |
Keywords provided by Grünenthal GmbH:
|
Osteoarthritis, knee Analgesia Pain Painful |
Additional relevant MeSH terms:
|
Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on June 17, 2013