Assessment of GRT6005 in Painful Osteoarthritis of the Knee

Osteoarthritis of the Knee Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01357837
• Other study ID #: 116918
• Secondary ID: 2010-022556-23KF
• Status: Completed
• Phase: Phase 2
• Start date: May 2011
• Est. completion date: December 2011

Study information

• Verified date: July 2021
• Source: Tris Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Drug:
• Matching Placebo
2 capsules of matching placebo once a day, in the morning, for a total of 28 days
• GRT6005
2 capsules containing a total of 75 µg GRT6005 once a day, in the morning, for a total of 28 days
• GRT6005
2 capsules containing a total of 200 µg GRT6005 once a day, in the morning, for a total of 28 days
• GRT6005
2 capsules containing a total of 400 µg GRT6005 once a day, in the morning, for a total of 28 days

Locations

Country	Name	City	State
Austria	Site 3604	Linz
Austria	Site 3605	Senftenberg
Austria	Site 3601	Wien
Austria	Site 3602	Wien
Austria	Site 3603	Wien
Poland	Site 3203	Bialystok
Poland	Site 3202	Elblag
Poland	Site 3208	Gdynia
Poland	Site 3206	Krakow
Poland	Site 3207	Lublin
Poland	Site 3210	Szczecin
Poland	Site 3201	Torun
Poland	Site 3204	Warsawa
Poland	Site 3211	Warszawa
Poland	Site 3213	Wloszczowa
Poland	Site 3205	Wroclaw
Spain	Site 3302	Barcelona
Spain	Site 3305	Barcelona
Spain	Site 3303	Coruna
Spain	Site 3312	Málaga
Spain	Site 3308	Mérida
Spain	Site 3310	Oviedo
Spain	Site 3311	Petrel
Spain	Site 3304	Santiago de Compostela
Spain	Site 3306	Sevilla
Spain	Site 3313	Torrelavega

Sponsors (2)

Lead Sponsor	Collaborator
Tris Pharma, Inc.	Forest Laboratories

Countries where clinical trial is conducted

Austria,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the pain intensity scores during the last week of the 4-week treatment period		4 weeks
Secondary	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		4 weeks
Secondary	Change from baseline in quality of health as measured by Short Form-12 Health Survey		4 weeks
Secondary	Response measured in percentage change of pain intensity since baseline		4 weeks
Secondary	Leeds Sleep Evaluation Questionnaire to quantify subjective impressions of sleep and waking		4 weeks
Secondary	Patient's Global Impression of Change (PGIC)		4 weeks
Secondary	Clinician's Global Impression of Change (CGIC)		4 weeks
Secondary	Weekly current pain intensity changes from baseline		4 weeks
Secondary	Rescue medication use		4 weeks
Secondary	Quality of Life EuroQoL-5 Dimension score, change from baseline		4 weeks
Secondary	Clinical Opioid Withdrawal Scale		4 weeks
Secondary	Plasma concentration		4 weeks
Secondary	Discontinuation from study due to treatment related adverse events		4 weeks
Secondary	Time to withdrawal from study		4 weeks