A Study of Single Dose Pain Therapy in Patients With Painful Diabetic Neuropathy (0000-115)(WITHDRAWN)

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00837941
First received: February 5, 2009
Last updated: July 30, 2010
Last verified: July 2010
  Purpose

The purpose of this study is to determine if analgesic efficacy can be detected with single dose administration in patients with chronic neuropathic pain due to painful diabetic neuropathy.


Condition Intervention Phase
Painful Diabetic Neuropathy
Drug: Comparator: A: Pregabalin
Drug: Comparator: B: Duloxetine
Drug: Comparator: C: Diphenhydramine hydrochloride
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Qualification of Single Dose Administration of Analgesic Therapy in the Treatment of Chronic Neuropathic Pain in Patients With Painful Diabetic Neuropathy

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • analgesic efficacy measured by patients self reported pain level after single dose administration [ Time Frame: 5-11 hours after single dose is administered ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The onset of analgesic efficacy following single dose of pregabalin and duloxetine hydrochloride versus placebo [ Time Frame: 24 hours after single dose is administered ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: April 2009
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
sequence 1 - Pregabalin, Duloxetine hydrochloride, Diphenhydramine hydrochloride
Drug: Comparator: A: Pregabalin
1 Pregabalin 300 mg capsule
Drug: Comparator: B: Duloxetine
1 Duloxetine hydrochloride 60 mg capsule
Drug: Comparator: C: Diphenhydramine hydrochloride
1 Diphenhydramine hydrochloride 25mg capsule
Experimental: 2
sequence 2 - Duloxetine hydrochloride, Pregabalin, Diphenhydramine hydrochloride
Drug: Comparator: A: Pregabalin
1 Pregabalin 300 mg capsule
Drug: Comparator: B: Duloxetine
1 Duloxetine hydrochloride 60 mg capsule
Drug: Comparator: C: Diphenhydramine hydrochloride
1 Diphenhydramine hydrochloride 25mg capsule
Experimental: 3
sequence 3 - Diphenhydramine hydrochloride, Duloxetine hydrochloride, Pregabalin
Drug: Comparator: A: Pregabalin
1 Pregabalin 300 mg capsule
Drug: Comparator: B: Duloxetine
1 Duloxetine hydrochloride 60 mg capsule
Drug: Comparator: C: Diphenhydramine hydrochloride
1 Diphenhydramine hydrochloride 25mg capsule
Experimental: 4
sequence 4 - Pregabalin, Diphenhydramine hydrochloride, Duloxetine hydrochloride
Drug: Comparator: A: Pregabalin
1 Pregabalin 300 mg capsule
Drug: Comparator: B: Duloxetine
1 Duloxetine hydrochloride 60 mg capsule
Drug: Comparator: C: Diphenhydramine hydrochloride
1 Diphenhydramine hydrochloride 25mg capsule
Experimental: 5
sequence 5 - Duloxetine hydrochloride, Diphenhydramine hydrochloride, Pregabalin
Drug: Comparator: A: Pregabalin
1 Pregabalin 300 mg capsule
Drug: Comparator: B: Duloxetine
1 Duloxetine hydrochloride 60 mg capsule
Drug: Comparator: C: Diphenhydramine hydrochloride
1 Diphenhydramine hydrochloride 25mg capsule
Experimental: 6
sequence 6 - Diphenhydramine hydrochloride, Pregabalin, Duloxetine hydrochloride
Drug: Comparator: A: Pregabalin
1 Pregabalin 300 mg capsule
Drug: Comparator: B: Duloxetine
1 Duloxetine hydrochloride 60 mg capsule
Drug: Comparator: C: Diphenhydramine hydrochloride
1 Diphenhydramine hydrochloride 25mg capsule

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has been treated for type 1 or 2 diabetes mellitus with glycosylated hemoglobin
  • Patient has pain in both feet that occurred after onset of diabetes
  • Patient agrees to maintain a consistent activity level throughout the study
  • Patient is not on chronic pain therapy, or is on a stable dose of one pain therapy
  • Female patients of reproductive potential must agree to use two acceptable methods of birth control through out the study
  • Patients taking a pain medication must be on a stable dose at least 1 month prior to participating in study

Exclusion Criteria:

  • Patient has a history of congestive heart failure
  • Patient has/had a seizure disorder
  • Patient has tried and failed 3 or more drugs to treat neuropathic pain
  • Patient is currently taking pregabalin or duloxetine hydrochloride
  • Patient has had a malignancy within the past 2 years (excluding basal cell carcinoma)
  • Patient has history of hepatitis B or C or HIV infection
  • Patient has skin-condition that may decrease sensitivity in area of neuropathic pain
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00837941

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00837941     History of Changes
Other Study ID Numbers: 2009_515, 115
Study First Received: February 5, 2009
Last Updated: July 30, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetic Neuropathies
Pain
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders
Diphenhydramine
Promethazine
Duloxetine
Pregabalin
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists

ClinicalTrials.gov processed this record on July 22, 2014