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Safety and Efficacy of GRT6005 in Pain Due to Diabetic Polyneuropathy

Primary Purpose

Pain, Diabetic Neuropathies

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

About this trial

This is an interventional treatment trial for Pain focused on measuring analgesia, analgesics, pain, chronic pain, neuropathic pain

Eligibility Criteria

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

Inclusion Criteria:

  • Men and women, 18 to 75 years old.
  • Type 1 or type 2 diabetes.
  • Painful DPN symptoms and signs for at least 3 months.
  • Blood glucose controlled with medication.
  • Glycosylated hemoglobin not greater than 9.5 or 11%, country dependent.
  • Prior analgesic medication.
  • Average score of 4 or greater on the 11 point NRS during the last 3 days prior to randomization.

Exclusion Criteria:

  • Impaired liver, cardiac or renal function.
  • Breastfeeding and pregnancy.
  • History of substance abuse, alcohol or medication.
  • Chronic gastrointestinal disease.
  • History of seizures and or epilepsy.
  • History or presence of malignancy.
  • Presence of painful medical conditions that are not due to diabetic neuropathy, e.g. rheumatoid arthritis.
  • Allergies to opioids, acetaminophen or excipients of the medications.

Sites / Locations

  • Site 4502
  • Site 4112
  • Site 4109
  • Site 4101
  • Site 4110
  • Site 4111
  • Site 4107
  • Site 4117
  • Site 4108
  • Site 4104
  • Site 4115
  • Site 4106
  • Site 4102
  • Site 4103
  • Site 4105
  • Site 4113
  • Site 4116
  • Site 4405
  • Site 4402
  • Site 4407
  • Site 4406
  • Site 4401

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

25 µg GRT6005

75 µg GRT6005

200 µg GRT6005

Matching Placebo

Arm Description

Participants allocated to this treatment arm will receive a daily dose of 25 µg GRT6005 per day

Participants allocated to this treatment arm will receive a daily dose of 75 µg GRT6005 per day

Participants allocated to this treatment arm will receive a daily dose of 200 µg GRT6005 per day

Participants allocated to this treatment arm will receive a dose of matched placebo once a day.

Outcomes

Primary Outcome Measures

Change in mean daily pain intensity score
Participants will be selected based on their medical history and clinical examination. Efficacy of the treatment (i.e., reduction of pain) will be evaluated with the 11-point numeric rating scale (NRS), where 0 represents no pain and 10 represents "pain as bad as you can imagine".

Secondary Outcome Measures

Response measured in percentage change of pain intensity from baseline
Changes in Quantitative Sensory Testing from baseline
Neuropathic Pain Scale, changes from baseline
Short Form of the Brief Pain Inventory, changes from baseline
Leeds Sleep Evaluation Questionnaire
Quality of Life Index -Short-Form-12®, from baseline
Patient's Global Impression of Change
Quality of Life EuroQoL-5 Dimension score, change from baseline
Rescue medication use
Clinical Opioid Withdrawal Scale
Plasma concentration

Full Information

First Posted
May 2, 2011
Last Updated
July 13, 2021
Sponsor
Tris Pharma, Inc.
Collaborators
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT01347671
Brief Title
Safety and Efficacy of GRT6005 in Pain Due to Diabetic Polyneuropathy
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 Pain Due to Diabetic Polyneuropathy.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (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 this trial is to investigate the efficacy and safety of GRT6005 in patients with painful diabetic neuropathy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Diabetic Neuropathies
Keywords
analgesia, analgesics, pain, chronic pain, neuropathic pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
189 (Actual)

8. Arms, Groups, and Interventions

Arm Title
25 µg GRT6005
Arm Type
Active Comparator
Arm Description
Participants allocated to this treatment arm will receive a daily dose of 25 µg GRT6005 per day
Arm Title
75 µg GRT6005
Arm Type
Active Comparator
Arm Description
Participants allocated to this treatment arm will receive a daily dose of 75 µg GRT6005 per day
Arm Title
200 µg GRT6005
Arm Type
Active Comparator
Arm Description
Participants allocated to this treatment arm will receive a daily dose of 200 µg GRT6005 per day
Arm Title
Matching Placebo
Arm Type
Placebo Comparator
Arm Description
Participants allocated to this treatment arm will receive a dose of matched placebo once a day.
Intervention Type
Drug
Intervention Name(s)
GRT6005
Intervention Description
25µg/day once daily
Intervention Type
Drug
Intervention Name(s)
GRT6005
Intervention Description
75 µg/day once daily
Intervention Type
Drug
Intervention Name(s)
GRT6005
Intervention Description
200 µg/day once daily
Intervention Type
Drug
Intervention Name(s)
Matching Placebo
Intervention Description
Once daily
Primary Outcome Measure Information:
Title
Change in mean daily pain intensity score
Description
Participants will be selected based on their medical history and clinical examination. Efficacy of the treatment (i.e., reduction of pain) will be evaluated with the 11-point numeric rating scale (NRS), where 0 represents no pain and 10 represents "pain as bad as you can imagine".
Time Frame
Baseline to Week 4
Secondary Outcome Measure Information:
Title
Response measured in percentage change of pain intensity from baseline
Time Frame
End of 4 Weeks
Title
Changes in Quantitative Sensory Testing from baseline
Time Frame
Baseline, week 1 and week 4
Title
Neuropathic Pain Scale, changes from baseline
Time Frame
End of 4 weeks
Title
Short Form of the Brief Pain Inventory, changes from baseline
Time Frame
End of 4 weeks
Title
Leeds Sleep Evaluation Questionnaire
Time Frame
End of treatment
Title
Quality of Life Index -Short-Form-12®, from baseline
Time Frame
End of treatment
Title
Patient's Global Impression of Change
Time Frame
End of treatment
Title
Quality of Life EuroQoL-5 Dimension score, change from baseline
Time Frame
End of 4 weeks
Title
Rescue medication use
Time Frame
End of 4 weeks
Title
Clinical Opioid Withdrawal Scale
Time Frame
End of 4 weeks
Title
Plasma concentration
Time Frame
End of 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women, 18 to 75 years old. Type 1 or type 2 diabetes. Painful DPN symptoms and signs for at least 3 months. Blood glucose controlled with medication. Glycosylated hemoglobin not greater than 9.5 or 11%, country dependent. Prior analgesic medication. Average score of 4 or greater on the 11 point NRS during the last 3 days prior to randomization. Exclusion Criteria: Impaired liver, cardiac or renal function. Breastfeeding and pregnancy. History of substance abuse, alcohol or medication. Chronic gastrointestinal disease. History of seizures and or epilepsy. History or presence of malignancy. Presence of painful medical conditions that are not due to diabetic neuropathy, e.g. rheumatoid arthritis. Allergies to opioids, acetaminophen or excipients of the medications.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Forst, Prof. Dr.
Organizational Affiliation
ikfe GmbH, Institut for Klinische Forschung und Entwicklung, Parcusstr. 8, 55116 Mainz, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Site 4502
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Site 4112
City
Aschaffenburg
ZIP/Postal Code
63739
Country
Germany
Facility Name
Site 4109
City
Bad Oeynhausen
ZIP/Postal Code
32545
Country
Germany
Facility Name
Site 4101
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Site 4110
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Site 4111
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Site 4107
City
Hamburg
ZIP/Postal Code
20253
Country
Germany
Facility Name
Site 4117
City
Hamburg
ZIP/Postal Code
22587
Country
Germany
Facility Name
Site 4108
City
Hannover
ZIP/Postal Code
30159
Country
Germany
Facility Name
Site 4104
City
Hannover
ZIP/Postal Code
30167
Country
Germany
Facility Name
Site 4115
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Site 4106
City
Kiel
ZIP/Postal Code
24119
Country
Germany
Facility Name
Site 4102
City
Lübeck
ZIP/Postal Code
23562
Country
Germany
Facility Name
Site 4103
City
Mainz
ZIP/Postal Code
55116
Country
Germany
Facility Name
Site 4105
City
Münster
ZIP/Postal Code
48145
Country
Germany
Facility Name
Site 4113
City
Schwerin
ZIP/Postal Code
19055
Country
Germany
Facility Name
Site 4116
City
Wangen
ZIP/Postal Code
88239
Country
Germany
Facility Name
Site 4405
City
Bucuresti
ZIP/Postal Code
010496
Country
Romania
Facility Name
Site 4402
City
Bucuresti
ZIP/Postal Code
011025
Country
Romania
Facility Name
Site 4407
City
Sibiu
ZIP/Postal Code
550166
Country
Romania
Facility Name
Site 4406
City
Timisoara
ZIP/Postal Code
300594
Country
Romania
Facility Name
Site 4401
City
Târgu-Mureş
ZIP/Postal Code
540139
Country
Romania

12. IPD Sharing Statement

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Safety and Efficacy of GRT6005 in Pain Due to Diabetic Polyneuropathy

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