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Completed

NCT Number: NCT01347671

Safety and Efficacy of GRT6005 in Pain Due to Diabetic Polyneuropathy

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

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Key information

Conditions

Pain Agnosia Chronic Pain Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Nervous System Diseases Neuralgia Neurobehavioral Manifestations Neurologic Manifestations Neuromuscular Diseases Pathological Conditions, Signs and Symptoms Perceptual Disorders Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site 4502, Sofia, Bulgaria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GRT6005

Drug

25µg/day once daily

Matching Placebo

Drug

Once daily

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Tris Pharma, Inc.

Industry

Collaborators

  • Forest Laboratories

Registry information

Official study 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.

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 4, 2011
Registry last updated
Jul 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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