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Trial record 1 of 1 for:    NCT01347671
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Safety and Efficacy of GRT6005 in Pain Due to Diabetic Polyneuropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01347671
Recruitment Status : Completed
First Posted : May 4, 2011
Last Update Posted : July 15, 2021
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Tris Pharma, Inc.

Study Description
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Brief Summary:
The purpose of this trial is to investigate the efficacy and safety of GRT6005 in patients with painful diabetic neuropathy.

Condition or disease Intervention/treatment Phase
Pain Diabetic Neuropathies Drug: GRT6005 Drug: Matching Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 189 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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 Pain Due to Diabetic Polyneuropathy.
Study Start Date : May 2011
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 25 µg GRT6005
Participants allocated to this treatment arm will receive a daily dose of 25 µg GRT6005 per day
 Drug: GRT6005
25µg/day once daily
Active Comparator: 75 µg GRT6005
Participants allocated to this treatment arm will receive a daily dose of 75 µg GRT6005 per day
 Drug: GRT6005
75 µg/day once daily
Active Comparator: 200 µg GRT6005
Participants allocated to this treatment arm will receive a daily dose of 200 µg GRT6005 per day
 Drug: GRT6005
200 µg/day once daily
Placebo Comparator: Matching Placebo
Participants allocated to this treatment arm will receive a dose of matched placebo once a day.
 Drug: Matching Placebo
Once daily


Outcome Measures
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Primary Outcome Measures :
  1. Change in mean daily pain intensity score [ Time Frame: Baseline to Week 4 ]

    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 :
  1. Response measured in percentage change of pain intensity from baseline [ Time Frame: End of 4 Weeks ]
  2. Changes in Quantitative Sensory Testing from baseline [ Time Frame: Baseline, week 1 and week 4 ]
  3. Neuropathic Pain Scale, changes from baseline [ Time Frame: End of 4 weeks ]
  4. Short Form of the Brief Pain Inventory, changes from baseline [ Time Frame: End of 4 weeks ]
  5. Leeds Sleep Evaluation Questionnaire [ Time Frame: End of treatment ]
  6. Quality of Life Index -Short-Form-12®, from baseline [ Time Frame: End of treatment ]
  7. Patient's Global Impression of Change [ Time Frame: End of treatment ]
  8. Quality of Life EuroQoL-5 Dimension score, change from baseline [ Time Frame: End of 4 weeks ]
  9. Rescue medication use [ Time Frame: End of 4 weeks ]
  10. Clinical Opioid Withdrawal Scale [ Time Frame: End of 4 weeks ]
  11. Plasma concentration [ Time Frame: End of 4 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01347671


Locations
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Sponsors and Collaborators
Tris Pharma, Inc.
Forest Laboratories
Investigators
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Principal Investigator: Thomas Forst, Prof. Dr. ikfe GmbH, Institut for Klinische Forschung und Entwicklung, Parcusstr. 8, 55116 Mainz, Germany
More Information
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Responsible Party: Tris Pharma, Inc.
ClinicalTrials.gov Identifier: NCT01347671    
Other Study ID Numbers: 430409
2010-022557-42 ( EudraCT Number )
First Posted: May 4, 2011    Key Record Dates
Last Update Posted: July 15, 2021
Last Verified: July 2021
Keywords provided by Tris Pharma, Inc.:
analgesia
analgesics
pain
chronic pain
neuropathic pain
Additional relevant MeSH terms:
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Diabetic Neuropathies
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
 Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases