Efficacy and Tolerability of Novel A2A Agonist in Treatment of Diabetic Neuropathic Pain

Diabetic Neuropathic Pain Clinical Trial

Official title:

A Double-blind, Placebo-controlled, Randomized, Parallel-group Study Evaluating the Efficacy and Tolerability of Oral BVT.115959, a Novel A2A Agonist, Versus Placebo in the Treatment of Diabetic Neuropathic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00452777
• Other study ID #: BVT.115959-005
• Status: Completed
• Phase: Phase 2
• First received: March 26, 2007
• Last updated: October 31, 2014
• Start date: May 2007
• Est. completion date: January 2008

Study information

• Verified date: October 2014
• Source: Swedish Orphan Biovitrum
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesCzech Republic: State Institute for Drug ControlUnited Kingdom: Medicines and Healthcare Products Regulatory AgencySouth Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and tolerability of BVT.115959 in diabetic patients with neuropathic pain who are either not on analgesia or are on stable analgesia in the month prior to entering the study.

Description:

The planned study is an exploratory study which aims to provide proof of the efficacy of BVT.115959 in the reduction of the symptoms of pain. Thus, the primary objective is to evaluate the anticipated analgesic properties of BVT.115959 in patients with diabetic neuropathic pain and to confirm its activity against placebo.

The study will evaluate the efficacy and tolerability of oral BVT.115959 7 mg administered three times a day (t.i.d.) versus a matching placebo in diabetic patients with neuropathic pain who are either not on analgesia or are on stable analgesia in the month prior to entering the study and who are being maintained on stable analgesia throughout the study. Eligible subjects will be randomized in a ratio of 2:1 (BVT.115959: placebo).

The study consists of a 1-week screening/baseline period, a 4-week treatment period and a 1 week follow-up period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 193
• Est. completion date: January 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• A diagnosis of type 1 or 2 diabetes mellitus and documented painful, symmetrical, sensorimotor polyneuropathy for at least 6 months

• Either no analgesic medication or on stable analgesic medication for at least 4 weeks

Exclusion Criteria:

• Female patients who are fertile and of child-bearing potential

• Clinically significant or unstable hepatic, respiratory, renal, hematologic, cardiovascular or peripheral vascular disease

• Painful conditions that may confound the evaluation of neuropathic pain

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Neuropathic Pain
• Neuralgia

Intervention

Drug:
• BVT.115959

• Placebo

Locations

Country	Name	City	State
Czech Republic	Biovitrum investigational site	Ceske Budejovice
Czech Republic	Biovitrum investigational site	Litomerice
Czech Republic	Biovitrum investigational site	Plzen
Czech Republic	Biovitrum investigational site	Praha 4
Czech Republic	Biovitrum investigational site	Praha 8
Germany	Biovitrum Investigational Site	Bad Kreuznach
Germany	Biovitrum Investigational Site	Berlin
Germany	Biovitrum Investigational Site	Dortmund
Germany	Biovitrum Investigational Site	Gelsenkirchen
Germany	Biovitrum Investigational Site	Hamburg
Germany	Biovitrum Investigational Site	Mainz
Germany	Biovitrum Investigational Site	Mannheim
Germany	Biovitrum Investigational Site	Neumunster
South Africa	Biovitrum Investigational Site	Bloemfontein
South Africa	Biovitrum Investigational Site	Durban
South Africa	Biovitrum Investigational Site	Kenilworth
South Africa	Biovitrum Investigational Site	Kraaifontein
South Africa	Biovitrum Investigational Site	Polokwane
South Africa	Biovitrum Investigational Site	Pretoria
South Africa	Biovitrum Investigational Site	Somerset West
South Africa	Biovitrum Investigational Site	Wynberg

Sponsors (1)

Lead Sponsor	Collaborator
Swedish Orphan Biovitrum

Countries where clinical trial is conducted

Czech Republic,  Germany,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean 24-hour pain intensity score from baseline using an 11-point Likert NRS assessed over the preceding 24 hours immediately upon awakening in the morning
Secondary	Present pain intensity using an 11-point Likert NRS assessed at bedtime
Secondary	Short-Form McGill Pain Questionnaire parameters
Secondary	Weekly mean sleep interference score
Secondary	Clinical Global Impression of Change and Patient's Global Impression of Change
Secondary	Quality of life
Secondary	Mood stability
Secondary	Time to study withdrawal