Neuropathic Pain Syndrome Patient Study (MK-0000-072)

Diabetic Neuropathy Clinical Trial

Official title:

A Double-Blind, Placebo-Controlled, Enriched-Enrollment, Randomized Withdrawal Study to Evaluate an Optimal Methodology for Conducting Proof of Concept Trials in Patients With Chronic Neuropathic Pain Syndromes Using Pregabalin as a Test Drug

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00570310
• Other study ID #: 0000-072
• Secondary ID: 2007_650
• Status: Completed
• Phase: Phase 1
• First received: December 7, 2007
• Last updated: April 20, 2015
• Start date: December 2007
• Est. completion date: September 2008

Study information

• Verified date: April 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the best way to conduct clinical trials in patients with neuropathic pain (nerve pain). This study will see if generic pregabalin has any effect on neuropathic pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient has moderate to severe nerve pain due to one of the following conditions:

Postherpetic neuralgia, Painful diabetic neuropathy, Small fiber neuropathy or idiopathic distal sensory polyneuropathy

• Patient is able to complete questionnaires in either English or Spanish

• Patient is at least 18 years of age

Exclusion Criteria:

• Patient is either pregnant or breastfeeding

• Patient has a history of angioedema (swelling beneath the skin surface) or peripheral edema (foot, leg, and/or ankle swelling)

• Patient has a history of congestive heart failure

• Patient has a seizure disorder

• Patient has a history of drug and/or alcohol abuse within the past 1 year

• Patient failed treatment due to lack of pain relief with more than three drugs for nerve pain

• Patient has had cancer (except basal cell carcinoma) within the past two years

• Patient anticipates the need for surgery while participating in the study

• Patient has a reported history of hepatitis B, C, or HIV infection

• Patient has another type of pain that is more painful than the nerve pain

• Patient has generalized anxiety disorder, untreated depression, psychosis, or post-traumatic stress disorder

• Patient is involved in litigation or receives worker's compensation related to nerve pain

Study Design

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

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Neuropathy
• Erythromelalgia
• Idiopathic Distal Sensory Polyneuropathy
• Neuralgia
• Neuralgia, Postherpetic
• Painful Small-Fiber Neuropathy
• Polyneuropathies

Intervention

Drug:
• Comparator: pregabalin
pregabalin (up to 600 mg/day by mouth (po)). Duration of Treatment: 6 Weeks
• Comparator: Placebo (unspecified)
pregabalin Pbo (up to 600 mg/day by mouth (po)). Duration of Treatment: 6 Weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Hewitt DJ, Ho TW, Galer B, Backonja M, Markovitz P, Gammaitoni A, Michelson D, Bolognese J, Alon A, Rosenberg E, Herman G, Wang H. Impact of responder definition on the enriched enrollment randomized withdrawal trial design for establishing proof of conce — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily Evening Patient Reported Pain Intensity Scores	Change from mean of last 3 days of maintenance period to last 3 days of double-blind period; Pain Intensity was rated on a 0-10 numeric rating scale (NRS: 0=no pain, 10=worst pain you can imagine)	Baseline and 6 Weeks	No
Secondary	'Time to Efficacy Failure' During the Randomized Withdrawal Portion of the Study	Time to treatment failure (3 day mean of average 24 hour pain intensity = 4 with at least a 30% increase relative to the last 3 days prior to randomization)	6 Weeks	No