Assessment of GRT6005 in Painful Osteoarthritis of the Knee

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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
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 October 29, 2014