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

NCT00794430 | Completed Phase 2 DMC

• 1 other identifier: V3381-2DPNP-02
• Study Type: interventional
• Target: 161
• Locations: 4 countries
• Sites: 31

Brief Summary

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.

Conditions

Diabetic Peripheral Neuropathic Pain

Keywords

Safety; Tolerability; Efficacy; Patients; Diabetic peripheral neuropathic pain.

Outcome Measures

Primary Outcomes (1)

• Investigate the safety and tolerability of V3381 in patients with diabetic neuropathic pain at doses of up to 400 mg bid

  17 weeks

Secondary Outcomes (1)

• Determine the efficacy of V3381 in the treatment of diabetic peripheral neuropathic pain at does of up to 400 mg bid

  17 weeks

Study Arms (2)

V3381

EXPERIMENTAL

V3381: titrated from 100 mg bid to maximum 400 mg bid over 4 weeks followed by maintenance phase at highest tolerated dose. Total duration of treatment 13 weeks.

Drug: V3381

Placebo

PLACEBO COMPARATOR

Placebo to match V3381, 100 mg, given according to the same regimen.

Drug: Placebo

Interventions

V3381 DRUG

100 mg capsules, titrated to a maximum of 400 mg bid for 13 weeks

Also known as: Indantadol

V3381

Placebo DRUG

Capsule, bid, for 13 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent
• Male or female aged 18 - 75 (18-65 Czech Republic)
• Diagnosis of diabetes mellitus
• No change in diabetes medications within 4 weeks before screening
• Daily pain attributed to diabetic neuropathy present for at least 6 months immediately prior to study entry
• 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
• Judged to be reliable and agree to keep all appointments required by the protocol
• 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:
• 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
• Full completion of daily diaries for at least 11 of the days up to Day -1
• Compliance in taking placebo run-in medication twice daily for at least 11 of the days up to Day -1

You may not qualify if:

• Any clinically significant neurologic disorders (except DPNP)
• Any clinically significant or unstable medical or psychiatric condition that would affect the patient's ability to participate in the study
• Prior renal transplant, current renal dialysis
• Pernicious anemia
• Untreated hypothyroidism
• Amputations or persistent ulceration due to diabetes mellitus
• Any cardiovascular condition that would contraindicate the use of sympathomimetic amines
• Uncontrolled hypertension
• Known or at high risk of HIV infection
• Any anticipated need for surgery during the study
• 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).
• Any malignancy in the past 2 years (except basal cell carcinoma)
• Pain that cannot be clearly differentiated from, or conditions that interfere with, the assessment of diabetic neuropathic pain
• 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.
• Use of opioids, especially meperidine (pethidine)

Sponsors & Collaborators

• Vernalis (R&D) Ltd: lead

Study Sites (31)

Clinical Trials Inc

Little Rock, Arkansas, 72205, United States

Location

Renstar Inc

Ocala, Florida, 34471, United States

Location

Radiant Research Inc

St. Petersburg, Florida, 33781, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Advanced Biomedical Research of America

Las Vegas, Nevada, 89123, United States

Location

Radiant Research Inc

Cincinnati, Ohio, 45249, United States

Location

Neurology & Neuroscience Center of Ohio

Toledo, Ohio, 43623, United States

Location

dgd Research

San Antonio, Texas, 78229-4801, United States

Location

Endeavor Clinical Trials

San Antonio, Texas, 78229, United States

Location

LMC Endocrinology

Thornhill, L4J 8L7, Canada

Location

LMC Endocrinology

Toronto, M4R 2G4, Canada

Location

Private Clinic

Brno, Brno, 612 00, Czechia

Location

Nemocnice Ceske Budejovice

České Budějovice, Ceske Budejovice, 370 87, Czechia

Location

Private Clinic

Holešov, Holesov, 769 01, Czechia

Location

Private Clinic

Hranice, Hranice, 753 01, Czechia

Location

Smetanovy sady

Karlovy Vary, Karlovy Vary, 360 01, Czechia

Location

Neurologicke oddeleni

Pardubice, Pardubice, 53 002, Czechia

Location

Private Clinic, Michnova 1622/4

Prague, Prague, 149 00, Czechia

Location

ResTrial s.r.o.

Prague, Prague, 180 00, Czechia

Location

Lekarsky dum Ormiga

Zlín, Zlín, 760 01, Czechia

Location

Diabetology Center

Zlín, 762 75, Czechia

Location

Royal Infirmary of Edinburgh

Edinburgh, Scotland, EH16 4SA, United Kingdom

Location

Ipswich Hospital NHS Trust

Ipswich, Suffolk, United Kingdom

Location

Barnsley Hospital

Barnsley, S75 2EP, United Kingdom

Location

MAC UK Neuroscience

Blackpool, FY2 0JH, United Kingdom

Location

Addenbrookes Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

Colchester Hospital University NHS Foundation Trust

Colchester, CO4 5JL, United Kingdom

Location

Pallium Research Group (Seacroft Hospital)

Leeds, LS14 6UH, United Kingdom

Location

St John's Hospital

Livingston, EH54 6PP, United Kingdom

Location

Barts and The London NHS Trust

London, EC1A 7BE, United Kingdom

Location

Royal Hallamshire Hospital

Sheffield, S10 2JF, United Kingdom

Location

MeSH Terms

Interventions

indantadol

Study Officials

• Christine Sang

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2008
• First Posted: November 20, 2008
• Study Start: December 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: June 3, 2016

Record last verified: 2015-01

Locations

US (9); GB (10); CA (2); CZ (10)