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Efficacy and Safety of CNV2197944 Versus Placebo in Patients With Diabetic Peripheral Neuropathy

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ClinicalTrials.gov Identifier: NCT01893125
Recruitment Status : Completed
First Posted : July 8, 2013
Last Update Posted : October 30, 2014
Sponsor:
Information provided by (Responsible Party):
Convergence Pharmaceuticals

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetic Peripheral Neuropathy Drug: CNV2197944 Drug: Placebo Phase 2

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised Three Week Double-blind Crossover Study to Compare the Efficacy and Safety of CNV2197944 75 mg Tid Versus Placebo in the Treatment of Neuropathic Pain in Patients With Diabetic Peripheral Neuropathy
Study Start Date : August 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CNV2197944
CNV2197944 75mg tid 21 days
Drug: CNV2197944
Placebo Comparator: Placebo
Placebo 1 cap tid 21 days
Drug: Placebo



Primary Outcome Measures :
  1. Pain Intensity Numerical Rating Scale [ Time Frame: 21 days ]

Secondary Outcome Measures :
  1. Pain Responder rates [ Time Frame: 21 days ]
  2. Neuropathic Pain Symptom Inventory [ Time Frame: 21 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01893125


Locations
Hungary
Petz Aladar County Teaching Hospital
Gyor, Hungary, H-9002
Sponsors and Collaborators
Convergence Pharmaceuticals
Investigators
Principal Investigator: Tibor Hidvegi, MD, PhD Dept. Metabolism and Diabetes, Gyor, Hungary

Responsible Party: Convergence Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01893125     History of Changes
Other Study ID Numbers: CNV2197944/202
First Posted: July 8, 2013    Key Record Dates
Last Update Posted: October 30, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases