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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01893125
Other study ID # CNV2197944/202
Secondary ID
Status Completed
Phase Phase 2
First received July 2, 2013
Last updated October 29, 2014
Start date August 2013
Est. completion date September 2014

Study information

Verified date October 2014
Source Convergence Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority Hungary: National Institute of PharmacyHungary: Ministry of Health, Social and Family AffairsCzech Republic: State Institute for Drug ControlRomania: National Medicines AgencyBulgaria: Bulgarian Drug AgencyPoland: Ministry of Health
Study type Interventional

Clinical Trial Summary

To investigate the effect of repeat oral dosing of CNV2197944 75 mg tid on the pain experienced in diabetic peripheral neuropathy (DPN) as measured by changes in PI-NRS after three weeks of treatment compared to the baseline period.


Description:

A 3 week randomised crossover study to investigate the effect of repeat oral dosing of CNV2197944 75 mg tid versus placebo for on the pain experienced in diabetic peripheral neuropathy (DPN). Each 3 week treatment period is seperated by a 2 week washout period. The primary outcome measure is the change from baseline in the PI-NRS after three weeks of treatment. Secondary outcome measures include pain responder rates, clinical and patient global impressions of pain, and the Neuropathic Pain Symptom Inventory.


Recruitment information / eligibility

Status Completed
Enrollment 126
Est. completion date September 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Male or female between 18 and 85 years of age inclusive, at the time of signing the informed consent

- Diabetes Mellitus (Type I or II)with HbA1c <9%

- Evidence of symmetrical bilateral pain in lower limbs with evidence of decreased sensation or impaired reflexes and a Michigan Neuropathy Screening -Instrument score of >3 on physical examination

- Patients with diabetic peripheral neuropathy (DPN) with pain at screening present for more than 6 months. The maximum duration of DPN will be no longer than 5 years

Exclusion Criteria:

- Patients having other severe pain, which may impair the self-assessment of the pain due to DPN

- Patients who have received nerve blocks for neuropathic pain within 4 weeks -Patients on other concomitant medications used to relieve the pain of DPN

- Patients with a documented failure to respond to a maximally tolerated dose regimen of gabapentin or pregabalin

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
CNV2197944

Placebo


Locations

Country Name City State
Hungary Petz Aladar County Teaching Hospital Gyor

Sponsors (1)

Lead Sponsor Collaborator
Convergence Pharmaceuticals

Country where clinical trial is conducted

Hungary, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Intensity Numerical Rating Scale 21 days No
Secondary Pain Responder rates 21 days No
Secondary Neuropathic Pain Symptom Inventory 21 days No
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