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Assessment of GRT6005 in Painful Osteoarthritis of the Knee

Primary Purpose

Osteoarthritis of the Knee

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Matching Placebo
GRT6005
GRT6005
GRT6005
Sponsored by
Tris Pharma, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring Osteoarthritis, knee, Analgesia, Pain, Painful

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Site 3604
  • Site 3605
  • Site 3603
  • Site 3602
  • Site 3601
  • Site 3203
  • Site 3202
  • Site 3208
  • Site 3206
  • Site 3207
  • Site 3210
  • Site 3201
  • Site 3204
  • Site 3211
  • Site 3213
  • Site 3205
  • Site 3305
  • Site 3302
  • Site 3303
  • Site 3312
  • Site 3308
  • Site 3310
  • Site 3311
  • Site 3304
  • Site 3306
  • Site 3313

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Matching Placebo

75 µg GRT6005

200 µg GRT6005

400 µg GRT6005

Arm Description

Once daily oral administration of matching placebo for 4 weeks.

Once daily oral administration of GRT6005 for 4 weeks.

Once daily oral administration of GRT6005 for 4 weeks.

Once daily oral administration of GRT6005 for 4 weeks.

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
May 19, 2011
Last Updated
July 13, 2021
Sponsor
Tris Pharma, Inc.
Collaborators
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT01357837
Brief Title
Assessment of GRT6005 in Painful Osteoarthritis of the Knee
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 Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tris Pharma, Inc.
Collaborators
Forest Laboratories

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee
Keywords
Osteoarthritis, knee, Analgesia, Pain, Painful

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
207 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Matching Placebo
Arm Type
Placebo Comparator
Arm Description
Once daily oral administration of matching placebo for 4 weeks.
Arm Title
75 µg GRT6005
Arm Type
Experimental
Arm Description
Once daily oral administration of GRT6005 for 4 weeks.
Arm Title
200 µg GRT6005
Arm Type
Experimental
Arm Description
Once daily oral administration of GRT6005 for 4 weeks.
Arm Title
400 µg GRT6005
Arm Type
Experimental
Arm Description
Once daily oral administration of GRT6005 for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Matching Placebo
Intervention Description
2 capsules of matching placebo once a day, in the morning, for a total of 28 days
Intervention Type
Drug
Intervention Name(s)
GRT6005
Intervention Description
2 capsules containing a total of 75 µg GRT6005 once a day, in the morning, for a total of 28 days
Intervention Type
Drug
Intervention Name(s)
GRT6005
Intervention Description
2 capsules containing a total of 200 µg GRT6005 once a day, in the morning, for a total of 28 days
Intervention Type
Drug
Intervention Name(s)
GRT6005
Intervention Description
2 capsules containing a total of 400 µg GRT6005 once a day, in the morning, for a total of 28 days
Primary Outcome Measure Information:
Title
Change from baseline in the pain intensity scores during the last week of the 4-week treatment period
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
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
Title
Change from baseline in quality of health as measured by Short Form-12 Health Survey
Time Frame
4 weeks
Title
Response measured in percentage change of pain intensity since baseline
Time Frame
4 weeks
Title
Leeds Sleep Evaluation Questionnaire to quantify subjective impressions of sleep and waking
Time Frame
4 weeks
Title
Patient's Global Impression of Change (PGIC)
Time Frame
4 weeks
Title
Clinician's Global Impression of Change (CGIC)
Time Frame
4 weeks
Title
Weekly current pain intensity changes from baseline
Time Frame
4 weeks
Title
Rescue medication use
Time Frame
4 weeks
Title
Quality of Life EuroQoL-5 Dimension score, change from baseline
Time Frame
4 weeks
Title
Clinical Opioid Withdrawal Scale
Time Frame
4 weeks
Title
Plasma concentration
Time Frame
4 weeks
Title
Discontinuation from study due to treatment related adverse events
Time Frame
4 weeks
Title
Time to withdrawal from study
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacek Olas, MD
Organizational Affiliation
Specjalistyczne Centrum Medyczne NZOZ NOWOMED,
Official's Role
Principal Investigator
Facility Information:
Facility Name
Site 3604
City
Linz
ZIP/Postal Code
4021
Country
Austria
Facility Name
Site 3605
City
Senftenberg
ZIP/Postal Code
3541
Country
Austria
Facility Name
Site 3603
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Site 3602
City
Wien
ZIP/Postal Code
1100
Country
Austria
Facility Name
Site 3601
City
Wien
ZIP/Postal Code
1130
Country
Austria
Facility Name
Site 3203
City
Bialystok
ZIP/Postal Code
15-337
Country
Poland
Facility Name
Site 3202
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Site 3208
City
Gdynia
ZIP/Postal Code
81-834
Country
Poland
Facility Name
Site 3206
City
Krakow
ZIP/Postal Code
30-349
Country
Poland
Facility Name
Site 3207
City
Lublin
ZIP/Postal Code
20-605
Country
Poland
Facility Name
Site 3210
City
Szczecin
ZIP/Postal Code
71-252
Country
Poland
Facility Name
Site 3201
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Site 3204
City
Warsawa
Country
Poland
Facility Name
Site 3211
City
Warszawa
ZIP/Postal Code
02-730
Country
Poland
Facility Name
Site 3213
City
Wloszczowa
ZIP/Postal Code
29-100
Country
Poland
Facility Name
Site 3205
City
Wroclaw
ZIP/Postal Code
50-088
Country
Poland
Facility Name
Site 3305
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
Site 3302
City
Barcelona
ZIP/Postal Code
08034
Country
Spain
Facility Name
Site 3303
City
Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Site 3312
City
Málaga
ZIP/Postal Code
29009
Country
Spain
Facility Name
Site 3308
City
Mérida
ZIP/Postal Code
06800
Country
Spain
Facility Name
Site 3310
City
Oviedo
ZIP/Postal Code
33009
Country
Spain
Facility Name
Site 3311
City
Petrel
ZIP/Postal Code
03610
Country
Spain
Facility Name
Site 3304
City
Santiago de Compostela
ZIP/Postal Code
15705
Country
Spain
Facility Name
Site 3306
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Site 3313
City
Torrelavega
ZIP/Postal Code
39300
Country
Spain

12. IPD Sharing Statement

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Assessment of GRT6005 in Painful Osteoarthritis of the Knee

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