Study of the Safety, Tolerability and Efficacy of V3381 in Patients With Diabetic Peripheral Neuropathic Pain

This study has been completed.
Sponsor:
Information provided by:
Vernalis (R&D) Ltd
ClinicalTrials.gov Identifier:
NCT00794430
First received: November 19, 2008
Last updated: July 21, 2011
Last verified: July 2011
  Purpose

Randomised, double-blind, placebo-controlled, parallel group, multicentre study of oral doses of V3381, titrated to effect. A 2-week single-blind run-in period will be followed by a 13 week double-blind titration and maintenance phase. Doses will be titrated up in 100 mg bid increments every one or two weeks, starting from 100 mg bid. A 2 week follow-up period will conclude patient participation in the study.


Condition Intervention Phase
Diabetic Peripheral Neuropathic Pain
Drug: V3381
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled, Multicentre, Parallel Group Study of the Safety, Tolerability and Efficacy of V3381 for up to 13 Weeks in Patients With Diabetic Peripheral Neuropathic Pain (DPNP)

Further study details as provided by Vernalis (R&D) Ltd:

Primary Outcome Measures:
  • Investigate the safety and tolerability of V3381 in patients with diabetic neuropathic pain at doses of up to 400 mg bid [ Time Frame: 17 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Determine the efficacy of V3381 in the treatment of diabetic peripheral neuropathic pain at does of up to 400 mg bid [ Time Frame: 17 weeks ] [ Designated as safety issue: No ]

Enrollment: 161
Study Start Date: December 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: V3381
Patients will be randomised to either V3381 or placebo. They will start the study with a single-blind 2-week run in phase prior to entering the double-blind 13-week treatment titration and maintenance phase.Doses will be titrated up in 100 mg bid increments every one or two weeks, starting from 100 mg bid. The daily maximum dose of V3381 will be 400 mg.
Drug: V3381
100 mg capsules, titrated to a maximum of 200 mg bid for 13 weeks
Other Name: Indantadol
Placebo Comparator: Placebo
Patients will be randomised to either V3381 or placebo. They will start the study with a single-blind 2-week run in phase prior to entering the double-blind 13-week treatment titration and maintenance phase.
Drug: Placebo
Capsule, bid, for 13 weeks

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed written informed consent
  2. Male or female aged 18 - 75 (18-65 Czech Republic)
  3. Diagnosis of diabetes mellitus
  4. No change in diabetes medications within 4 weeks before screening
  5. Daily pain attributed to diabetic neuropathy present for at least 6 months immediately prior to study entry
  6. Presents with pain due to bilateral peripheral neuropathy caused by Type I or Type II diabetes mellitus. Pain must have begun in the feet, with relatively symmetrical onset. Diagnosis confirmed by a score of at least 2 on Section B of the MNSI
  7. Judged to be reliable and agree to keep all appointments required by the protocol
  8. Females should be of non child-bearing potential (i.e. surgically sterilized or >1 year post-menopause). Male subjects who are sexually active with a female partner of child bearing potential must agree to use a barrier method of contraception (eg condom, diaphragm or cervical cap in the female female partner) for the duration of the study (until the follow up visit)

    Additionally, at the baseline visit:

  9. A mean average pain intensity of at least 4, but less than or equal to 9, on an 11 point Likert NPRS recorded twice daily during the two week placebo run-in; any patient who experiences a >30% decrease in the mean pain score compared to Day -14 during placebo run-in will be excluded, regardless of whether their final score is >4
  10. Full completion of daily diaries for at least 11 of the days up to Day -1
  11. Compliance in taking placebo run-in medication twice daily for at least 11 of the days up to Day -1

Exclusion Criteria:

  1. Any clinically significant neurologic disorders (except DPNP)
  2. Any clinically significant or unstable medical or psychiatric condition that would affect the patient's ability to participate in the study
  3. Prior renal transplant, current renal dialysis
  4. Pernicious anemia
  5. Untreated hypothyroidism
  6. Amputations or persistent ulceration due to diabetes mellitus
  7. Any cardiovascular condition that would contraindicate the use of sympathomimetic amines
  8. Uncontrolled hypertension
  9. Known or at high risk of HIV infection
  10. Any anticipated need for surgery during the study
  11. Increased risk of seizures (defined as a history of seizure disorder (including alcoholic seizures), family history of seizures and history of head trauma that resulted in loss of consciousness or concussion).
  12. Any malignancy in the past 2 years (except basal cell carcinoma)
  13. Pain that cannot be clearly differentiated from, or conditions that interfere with, the assessment of diabetic neuropathic pain
  14. Use of anticonvulsants, antidepressants (particularly MAO inhibitors), or prescription membrane-stabilizing agents, including topical therapies. Patients currently taking drugs in these classes may have them discontinued prior to entry into the placebo run-in period.
  15. Use of opioids, especially meperidine (pethidine)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00794430

Locations
United States, Arkansas
Clinical Trials Inc
Little Rock, Arkansas, United States, 72205
United States, Florida
Renstar Inc
Ocala, Florida, United States, 34471
Radiant Research Inc
St petersburg, Florida, United States, 33781
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Nevada
Advanced Biomedical Research of America
Las Vegas, Nevada, United States, 89123
United States, Ohio
Radiant Research Inc
Cincinnati, Ohio, United States, 45249
Neurology & Neuroscience Center of Ohio
Toledo, Ohio, United States, 43623
United States, Texas
dgd Research
San Antonio, Texas, United States, 78229-4801
Endeavor Clinical Trials
San Antonio, Texas, United States, 78229
Canada
LMC Endocrinology
Thornhill, Canada, L4J 8L7
LMC Endocrinology
Toronto, Canada, M4R 2G4
Czech Republic
ResTrial s.r.o.
Praha, Prague, Czech Republic, 180 00
Private Clinic
Brno, Czech Republic, 612 00
Nemocnice Ceske Budejovice
Ceske Budejovice, Czech Republic, 370 87
Private Clinic
Holesov, Czech Republic, 769 01
Private Clinic
Hranice, Czech Republic, 753 01
Smetanovy sady
Karlovy Vary, Czech Republic, 360 01
Neurologicke oddeleni
Pardubice, Czech Republic, 53 002
Private Clinic, Michnova 1622/4
Prague, Czech Republic, 149 00
Diabetology Center
Zlin, Czech Republic, 762 75
Lekarsky dum Ormiga
Zlin, Czech Republic, 760 01
United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, Scotland, United Kingdom, EH16 4SA
Ipswich Hospital NHS Trust
Ipswich, Suffolk, United Kingdom
Barnsley Hospital
Barnsley, United Kingdom, S75 2EP
MAC UK Neuroscience
Blackpool, United Kingdom, FY2 0JH
Addenbrookes Hospital
Cambridge, United Kingdom, CB2 0QQ
Colchester Hospital University NHS Foundation Trust
Colchester, United Kingdom, CO4 5JL
Pallium Research Group (Seacroft Hospital)
Leeds, United Kingdom, LS14 6UH
St John's Hospital
Livingston, United Kingdom, EH54 6PP
Barts and The London NHS Trust
London, United Kingdom, EC1A 7BE
Royal Hallamshire Hospital
Sheffield, United Kingdom, S10 2JF
Sponsors and Collaborators
Vernalis (R&D) Ltd
Investigators
Principal Investigator: Christine Sang Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Dr. Christine Sang, MD, MPH, Brigham and Woman's Hospital
ClinicalTrials.gov Identifier: NCT00794430     History of Changes
Other Study ID Numbers: V3381-2DPNP-02
Study First Received: November 19, 2008
Last Updated: July 21, 2011
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Czech Republic: State Institute for Drug Control

Keywords provided by Vernalis (R&D) Ltd:
Safety
Tolerability
Efficacy
Patients
Diabetic peripheral neuropathic pain.

Additional relevant MeSH terms:
Neuralgia
Diabetic Neuropathies
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014