Double Blind RCT of Bicifadine SR in Outpatients With Chronic Neuropathic Pain Associated With Diabetes

XTL Biopharmaceuticals

Status and phase: Unknown; Phase 2

Conditions: Diabetic Peripheral Neuropathy

Treatments: Drug: Bicifadine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00553592

XTL B07-001

Details and patient eligibility

About

To compare the efficacy of two dosages (600mg/day and 1200mg/day) of bicifadine SR with placebo for 14 weeks in reduction of chronic neuropathic patin (measured by a daily rating of pain intensity) associated with diabetic periperal neuropathy in adult outpatients.

To compare the tolerability of two dosages of bicifadine SR with placebo in adult outpaitens treated for chronic neuropathic pain for 14 weeks associated with diabetic peripheral neuropathy.

Enrollment: 336 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female, 18 years or older
• Diagnosis of type-1 or type 2 non-insulin dependent diabetes mellitus
• Chronic bilateral pain due to diabetic neuropathy
• Pain for at least six months
• Primary pain is located in the feet
• Others-contact site for information

Exclusion criteria

• Symptoms of other painful conditions
• Presence of amputations other than toes
• Clinically significant psychiatric or other neurological disorder
• Use of certain medications
• Clinically important other diseases
• Pregnancy
• History of alcohol or narcotic abuse within two years
• Others-contact site for information

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

336 participants in 3 patient groups, including a placebo group

Drug

Experimental group

Description:

Bicifadine

Treatment:

Drug: Bicifadine

Drug: Bicifadine

Drug: Bicifadine

Drug: 2

Experimental group

Description:

Bicifadine

Treatment:

Drug: Bicifadine

Drug: Bicifadine

Drug: Bicifadine

Control

Placebo Comparator group

Description:

Placebo of Bicifadine

Treatment:

Drug: Bicifadine

Drug: Bicifadine

Drug: Bicifadine