Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01357837
Previous Study | Return to List | Next Study

Assessment of GRT6005 in Painful Osteoarthritis of the Knee

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01357837
Recruitment Status : Completed
First Posted : May 23, 2011
Last Update Posted : January 30, 2019
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Grünenthal GmbH

Tracking Information
First Submitted Date  ICMJE May 19, 2011
First Posted Date  ICMJE May 23, 2011
Last Update Posted Date January 30, 2019
Study Start Date  ICMJE May 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2019)
Change from baseline in the pain intensity scores during the last week of the 4-week treatment period [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 20, 2011)
Change from baseline in the pain intensity scores during the last week of the 4-week treatment period. [ Time Frame: 4 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2019)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2011)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of GRT6005 in Painful Osteoarthritis of the Knee
Official Title  ICMJE 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
Brief Summary The purpose of the trial is to determine whether GRT6005 is effective in patients with pain due to osteoarthritis of the knee.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis of the Knee
Intervention  ICMJE
  • Drug: Matching Placebo
    2 capsules of matching placebo once a day, in the morning, for a total of 28 days
  • Drug: GRT6005
    2 capsules containing a total of 75 µg GRT6005 once a day, in the morning, for a total of 28 days
  • Drug: GRT6005
    2 capsules containing a total of 200 µg GRT6005 once a day, in the morning, for a total of 28 days
  • Drug: GRT6005
    2 capsules containing a total of 400 µg GRT6005 once a day, in the morning, for a total of 28 days
Study Arms  ICMJE
  • Placebo Comparator: Matching Placebo
    Once daily oral administration of matching placebo for 4 weeks.
    Intervention: Drug: Matching Placebo
  • Experimental: 75 µg GRT6005
    Once daily oral administration of GRT6005 for 4 weeks.
    Intervention: Drug: GRT6005
  • Experimental: 200 µg GRT6005
    Once daily oral administration of GRT6005 for 4 weeks.
    Intervention: Drug: GRT6005
  • Experimental: 400 µg GRT6005
    Once daily oral administration of GRT6005 for 4 weeks.
    Intervention: Drug: GRT6005
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 22, 2013)
207
Original Estimated Enrollment  ICMJE
 (submitted: May 20, 2011)
170
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Poland,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01357837
Other Study ID Numbers  ICMJE 116918
2010-022556-23 ( EudraCT Number )
KF6005/03 ( Other Identifier: Sponsor )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Grünenthal GmbH
Study Sponsor  ICMJE Grünenthal GmbH
Collaborators  ICMJE Forest Laboratories
Investigators  ICMJE
Principal Investigator: Jacek Olas, MD Specjalistyczne Centrum Medyczne NZOZ NOWOMED,
PRS Account Grünenthal GmbH
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP