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Assessment of GRT6005 in Painful Osteoarthritis of the Knee

This study has been completed.
Forest Laboratories
Information provided by (Responsible Party):
Grünenthal GmbH Identifier:
First received: May 19, 2011
Last updated: January 22, 2013
Last verified: January 2013
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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 ]

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 ]
  • Change from baseline in quality of health as measured by Short Form-12 Health Survey [ Time Frame: 4 weeks ]
  • Response measured in percentage change of pain intensity since baseline. [ Time Frame: 4 weeks ]
  • Leeds Sleep Evaluation Questionnaire to quantify subjective impressions of sleep and waking. [ Time Frame: 4 weeks ]
  • Patient's Global Impression of Change (PGIC). [ Time Frame: 4 weeks ]
  • Clinician's Global Impression of Change (CGIC). [ Time Frame: 4 weeks ]
  • Weekly current pain intensity changes from baseline. [ Time Frame: 4 weeks ]
  • Rescue medication use [ Time Frame: 4 weeks ]
  • Quality of Life EuroQoL-5 Dimension score, change from baseline. [ Time Frame: 4 weeks ]
  • Clinical Opioid Withdrawal Scale [ Time Frame: 4 weeks ]
  • Plasma concentration [ Time Frame: 4 weeks ]
  • Discontinuation from study due to treatment related adverse events [ Time Frame: 4 weeks ]
  • Time to withdrawal from study [ Time Frame: 4 weeks ]

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.

Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01357837

Site 3604
Linz, Austria, 4021
Site 3605
Senftenberg, Austria, 3541
Site 3603
Wien, Austria, 1090
Site 3602
Wien, Austria, 1100
Site 3601
Wien, Austria, 1130
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
Site 3305
Barcelona, Spain, 08028
Site 3302
Barcelona, Spain, 08034
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
Principal Investigator: Jacek Olas, MD Specjalistyczne Centrum Medyczne NZOZ NOWOMED,
  More Information

Responsible Party: Grünenthal GmbH Identifier: NCT01357837     History of Changes
Other Study ID Numbers: 116918
2010-022556-23 ( EudraCT Number )
Study First Received: May 19, 2011
Last Updated: January 22, 2013

Keywords provided by Grünenthal GmbH:
Osteoarthritis, knee

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on April 28, 2017