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Trial record 1 of 1 for:    NCT01357837
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Assessment of GRT6005 in Painful Osteoarthritis of the Knee

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ClinicalTrials.gov Identifier: NCT01357837
Recruitment Status : Completed
First Posted : May 23, 2011
Last Update Posted : July 15, 2021
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Tris Pharma, Inc.

Study Description
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Brief Summary:
The purpose of the trial is to determine whether GRT6005 is effective in patients with pain due to osteoarthritis of the knee.

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Knee Drug: Matching Placebo Drug: GRT6005 Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 207 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : May 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. Change from baseline in quality of health as measured by Short Form-12 Health Survey [ Time Frame: 4 weeks ]
  3. Response measured in percentage change of pain intensity since baseline [ Time Frame: 4 weeks ]
  4. Leeds Sleep Evaluation Questionnaire to quantify subjective impressions of sleep and waking [ Time Frame: 4 weeks ]
  5. Patient's Global Impression of Change (PGIC) [ Time Frame: 4 weeks ]
  6. Clinician's Global Impression of Change (CGIC) [ Time Frame: 4 weeks ]
  7. Weekly current pain intensity changes from baseline [ Time Frame: 4 weeks ]
  8. Rescue medication use [ Time Frame: 4 weeks ]
  9. Quality of Life EuroQoL-5 Dimension score, change from baseline [ Time Frame: 4 weeks ]
  10. Clinical Opioid Withdrawal Scale [ Time Frame: 4 weeks ]
  11. Plasma concentration [ Time Frame: 4 weeks ]
  12. Discontinuation from study due to treatment related adverse events [ Time Frame: 4 weeks ]
  13. Time to withdrawal from study [ Time Frame: 4 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01357837


Locations
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Sponsors and Collaborators
Tris Pharma, Inc.
Forest Laboratories
Investigators
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Principal Investigator: Jacek Olas, MD Specjalistyczne Centrum Medyczne NZOZ NOWOMED,
More Information
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Responsible Party: Tris Pharma, Inc.
ClinicalTrials.gov Identifier: NCT01357837    
Other Study ID Numbers: 116918
2010-022556-23 ( EudraCT Number )
KF6005/03 ( Other Identifier: Sponsor )
First Posted: May 23, 2011    Key Record Dates
Last Update Posted: July 15, 2021
Last Verified: July 2021
Keywords provided by Tris Pharma, Inc.:
Osteoarthritis, knee
Analgesia
Pain
Painful
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases