Assessment of GRT6005 in Painful Osteoarthritis of the Knee

Sponsor

Tris Pharma, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01357837

Collaborator

Forest Laboratories (Industry)

207

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis of the Knee	Drug: Matching Placebo Drug: GRT6005 Drug: GRT6005 Drug: GRT6005	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

207 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

May 1, 2011

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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
Experimental: 200 µg GRT6005 Once daily oral administration of GRT6005 for 4 weeks.	Drug: GRT6005 2 capsules containing a total of 200 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 400 µg GRT6005 once a day, in the morning, for a total of 28 days

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Site 3604	Linz	Austria	4021
2	Site 3605	Senftenberg	Austria	3541
3	Site 3603	Wien	Austria	1090
4	Site 3602	Wien	Austria	1100
5	Site 3601	Wien	Austria	1130
6	Site 3203	Bialystok	Poland	15-337
7	Site 3202	Elblag	Poland	82-300
8	Site 3208	Gdynia	Poland	81-834
9	Site 3206	Krakow	Poland	30-349
10	Site 3207	Lublin	Poland	20-605
11	Site 3210	Szczecin	Poland	71-252
12	Site 3201	Torun	Poland	87-100
13	Site 3204	Warsawa	Poland
14	Site 3211	Warszawa	Poland	02-730
15	Site 3213	Wloszczowa	Poland	29-100
16	Site 3205	Wroclaw	Poland	50-088
17	Site 3305	Barcelona	Spain	08028
18	Site 3302	Barcelona	Spain	08034
19	Site 3303	Coruna	Spain	15006
20	Site 3312	Málaga	Spain	29009
21	Site 3308	Mérida	Spain	06800
22	Site 3310	Oviedo	Spain	33009
23	Site 3311	Petrel	Spain	03610
24	Site 3304	Santiago de Compostela	Spain	15705
25	Site 3306	Sevilla	Spain	41009
26	Site 3313	Torrelavega	Spain	39300