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

NCT00570310 | Completed Phase 1 Results

• 2 other identifiers: 0000-0722007_650
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Neuralgia, Postherpetic; Diabetic Neuropathy; Painful Small-Fiber Neuropathy; Idiopathic Distal Sensory Polyneuropathy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 'Time to Efficacy Failure' During the Randomized Withdrawal Portion of the Study

  6 Weeks

Study Arms (2)

A

ACTIVE COMPARATOR

Patients in Group A will remain on pregabalin (up to 600 mg/day po) treatment for the entire double-blind period.

Drug: Comparator: pregabalin

B

PLACEBO COMPARATOR

Patients in Group B will be treated with placebo.

Drug: Comparator: Placebo (unspecified)

Interventions

Comparator: pregabalin DRUG

pregabalin (up to 600 mg/day by mouth (po)). Duration of Treatment: 6 Weeks

A

Comparator: Placebo (unspecified) DRUG

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

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related 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 concept in neuropathic pain. Pain. 2011 Mar;152(3):514-521. doi: 10.1016/j.pain.2010.10.050. Epub 2010 Dec 23.

  PMID: 21185118 RESULT

MeSH Terms

Conditions

Neuralgia, Postherpetic; Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2007
• First Posted: December 10, 2007
• Study Start: December 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: May 7, 2015
• Results First Posted: February 5, 2010

Record last verified: 2015-04