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Completed

NCT Number: NCT01357837

Assessment of GRT6005 in Painful Osteoarthritis of the Knee

The purpose of the trial is to determine whether GRT6005 is effective in patients with pain due to osteoarthritis of the knee.

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Key information

Conditions

Osteoarthritis of the Knee Agnosia Arthritis Joint Diseases Musculoskeletal Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Osteoarthritis Osteoarthritis, Knee Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Rheumatic Diseases Signs and Symptoms

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site 3604, Linz, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Matching Placebo

Drug

2 capsules of matching placebo once a day, in the morning, for a total of 28 days

GRT6005

Drug

2 capsules containing a total of 75 µg GRT6005 once a day, in the morning, for a total of 28 days

Primary outcomes

  1. Change from baseline in the pain intensity scores during the last week of the 4-week treatment period

    Time frame: 4 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Tris Pharma, Inc.

Industry

Collaborators

  • Forest Laboratories

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
May 23, 2011
Registry last updated
Jul 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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