Assessment of GRT6005 in Painful Osteoarthritis of the Knee

July 13, 2021 updated by: Tris Pharma, Inc.

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
207

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Linz, Austria, 4021
        • Site 3604
      • Senftenberg, Austria, 3541
        • Site 3605
      • Wien, Austria, 1090
        • Site 3603
      • Wien, Austria, 1100
        • Site 3602
      • Wien, Austria, 1130
        • Site 3601
  • Poland
      • Bialystok, Poland, 15-337
        • Site 3203
      • Elblag, Poland, 82-300
        • Site 3202
      • Gdynia, Poland, 81-834
        • Site 3208
      • Krakow, Poland, 30-349
        • Site 3206
      • Lublin, Poland, 20-605
        • Site 3207
      • Szczecin, Poland, 71-252
        • Site 3210
      • Torun, Poland, 87-100
        • Site 3201
      • Warsawa, Poland
        • Site 3204
      • Warszawa, Poland, 02-730
        • Site 3211
      • Wloszczowa, Poland, 29-100
        • Site 3213
      • Wroclaw, Poland, 50-088
        • Site 3205
  • Spain
      • Barcelona, Spain, 08028
        • Site 3305
      • Barcelona, Spain, 08034
        • Site 3302
      • Coruna, Spain, 15006
        • Site 3303
      • Málaga, Spain, 29009
        • Site 3312
      • Mérida, Spain, 06800
        • Site 3308
      • Oviedo, Spain, 33009
        • Site 3310
      • Petrel, Spain, 03610
        • Site 3311
      • Santiago de Compostela, Spain, 15705
        • Site 3304
      • Sevilla, Spain, 41009
        • Site 3306
      • Torrelavega, Spain, 39300
        • Site 3313

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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
Experimental: 200 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
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
Experimental: 400 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
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline in the pain intensity scores during the last week of the 4-week treatment period
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
4 weeks
Change from baseline in quality of health as measured by Short Form-12 Health Survey
Time Frame: 4 weeks
4 weeks
Response measured in percentage change of pain intensity since baseline
Time Frame: 4 weeks
4 weeks
Leeds Sleep Evaluation Questionnaire to quantify subjective impressions of sleep and waking
Time Frame: 4 weeks
4 weeks
Patient's Global Impression of Change (PGIC)
Time Frame: 4 weeks
4 weeks
Clinician's Global Impression of Change (CGIC)
Time Frame: 4 weeks
4 weeks
Weekly current pain intensity changes from baseline
Time Frame: 4 weeks
4 weeks
Rescue medication use
Time Frame: 4 weeks
4 weeks
Quality of Life EuroQoL-5 Dimension score, change from baseline
Time Frame: 4 weeks
4 weeks
Clinical Opioid Withdrawal Scale
Time Frame: 4 weeks
4 weeks
Plasma concentration
Time Frame: 4 weeks
4 weeks
Discontinuation from study due to treatment related adverse events
Time Frame: 4 weeks
4 weeks
Time to withdrawal from study
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tris Pharma, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Forest Laboratories

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jacek Olas, MD, Specjalistyczne Centrum Medyczne NZOZ NOWOMED,

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 23, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 116918
  • 2010-022556-23 (EudraCT Number)
  • KF6005/03 (Other Identifier: Sponsor)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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