A Study To Compare Pregabalin/PF-00489791 Combination Versus Pregabalin Alone In Post-Herpetic Neuralgia

Postherpetic Neuralgia Clinical Trial

Official title:

A TWO WEEK DOUBLE-BLIND PLACEBO-CONTROLLED CROSSOVER STUDY TO COMPARE THE EFFICACY AND SAFETY OF A PREGABALIN/PF-00489791 COMBINATION VERSUS PREGABALIN ALONE IN PATIENTS WITH POST-HERPETIC NEURALGIA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00599638
• Other study ID #: B0261002
• Status: Completed
• Phase: Phase 2
• Start date: April 9, 2008
• Est. completion date: December 23, 2008

Study information

• Verified date: August 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pregabalin is an alpha-2 delta ligand approved for the treatment of neuropathic pain, however, not all patients will respond to this drug. This study will compare the efficacy of pregabalin when administered with an experimental drug PF-00489791, in patients with post-herpetic neuralgia. The efficacy of this combination will be compared to pregabalin alone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 23, 2008
• Est. primary completion date: December 16, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female of non-childbearing potential
• Pain present for more than 3 months after healing of herpes zoster skin rash
• VAS score of >=40mm at screening and baseline visits

Exclusion Criteria:

• Patients with pain conditions which might impair the assessment of postherpetic neuralgia
• Skin conditions in the affected dermatome that could alter sensation other than postherpetic neuralgia
• History or diagnosis of DSM IV major depressive disorder

Related Conditions & MeSH terms

• Neuralgia
• Neuralgia, Postherpetic
• Postherpetic Neuralgia

Intervention

Drug:
• pregabalin
75mg bid titrating to 150mg bid on day 4
• pregabalin/PF-00489791
Pregabalin 75mg bid titrating to 150mg bid on day 4; PF-00489791: 4mg od titrating to 10mg od on day 4
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Medical Clinic of North Texas	Arlington	Texas
United States	Futuresearch Trials	Austin	Texas
United States	FutureSearch Trials of Neurology	Austin	Texas
United States	Legacy Pharma Research	Bismarck	North Dakota
United States	Parkinson's Disease and Movement Disorders Center of Boca Raton	Boca Raton	Florida
United States	Bradenton Research Center	Bradenton	Florida
United States	Beacon Clinical Research	Brockton	Massachusetts
United States	Radiant Research	Chandler	Arizona
United States	Patient Priority Clinical Sites, LLC	Cincinnati	Ohio
United States	Community Medical Providers	Clovis	California
United States	Absolute Primary Care, P.C.	Cranberry Twp.	Pennsylvania
United States	New England Center for Clinical Research	Cranston	Rhode Island
United States	Pinnacle Pain Medicine	Dallas	Texas
United States	Arthritis Associates of South Florida	Delray Beach	Florida
United States	Delray Research Associates	Delray Beach	Florida
United States	The Medical Group Of Texas	Fort Worth	Texas
United States	Sierra Medical Research (Administrative only site)	Fresno	California
United States	Neurological Research Center at Hattiesburg Clinic	Hattiesburg	Mississippi
United States	North Alabama RadioPharmacy	Huntsville	Alabama
United States	Tennessee Valley Pain Consultants	Huntsville	Alabama
United States	Medical and Surgical Clinic of Irving	Irving	Texas
United States	CRC of Jackson	Jackson	Mississippi
United States	Physician's Surgery Center	Jackson	Mississippi
United States	John P. Murtha Neuroscience and Pain Institute	Johnstown	Pennsylvania
United States	Memorial Medical Center	Johnstown	Pennsylvania
United States	North State Clinical Research, PLLC	Lenoir	North Carolina
United States	Novara Clinical Research	Mesa	Arizona
United States	Prime-Care Clinical Research	Mission Viejo	California
United States	Centennial Park Medical Building	North Platte	Nebraska
United States	Neurology Associates of Great Plains	North Platte	Nebraska
United States	ICPS Group	Norwood	Massachusetts
United States	American Medical Research, Inc.	Oak Brook	Illinois
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Mark A. Fisher, MD-Private Practice	Oklahoma City	Oklahoma
United States	Finger Lakes Clinical Research	Rochester	New York
United States	Clinvest	Springfield	Missouri
United States	River Region Research, LLC	Tallassee	Alabama
United States	Office of Laszlo J Mate, M.D.	West Palm Beach	Florida
United States	The Center for Clinical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Pain Score on Daily Pain Rating Scale (DPRS)	Pain was assessed by using a daily pain rating scale that consisted of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"), higher scores indicate more pain intensity. Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. Self-assessment was performed daily. The mean pain score was defined as the mean of the last 7 daily pain ratings scale scores while taking study medication, at end of each treatment period: Period 1 (Week 2) and Period 2 (Week 6), respectively. Mean pain score had a score range of 0 (no pain) to 10 (worst possible pain), higher scores indicate more pain. Cumulative data of mean pain scores at end of treatment for both the periods was calculated and reported in terms of adjusted mean and standard error.	End of treatment period (included both Week 2 and Week 6)
Secondary	Percentage of Participants With Patient Global Impression of Change (PGIC) Score	The PGIC is a participant-rated instrument that measures change in the participants' overall status on a 7-point scale. Scores range from 1 (very much improved) to 7 (very much worse), lower scores indicated more improvement. PGIC was evaluated using 3 categories: improvement (scores 1-3), no change (score 4), and worsening (scores 5-7). In this outcome measure percentage of participants with categories: improved, no change and worsening, based on PGIC score were reported. Cumulative data at end of treatment for both the periods (Period 1 [Week 2] and Period 2 [Week6]) was calculated and reported.	End of treatment period (included both Week 2 and Week 6)
Secondary	Pain Visual Analogue Scale (VAS) at Baseline and Week 4	Participants marked intensity of the pain on a scale, ranging from 0 millimeters (mm) = no pain to 100 mm = worst possible pain, where higher scores indicate more pain.	Baseline, Week 4
Secondary	Neuropathic Pain Symptom Inventory (NPSI)	Participant rated 10-item questionnaire to evaluate different symptoms of neuropathic pain (spontaneous pain like [item 1 to 3]: burning, squeezing, pressure; painful attack like [item 4 to 5]: electric shock, stabbing; pain provoked on [item 6 to 8]: light touching, pressure, contact with something cold; abnormal sensations like [item 9 to 10]: pins and needles, tingling). Each item was rated on an 11-point numerical scale range: 0 (absence of pain) to 10 (maximum intensity of pain). Total NPSI scale ranged from 0 (no pain) to 100 (maximum pain). Higher scores indicate a greater intensity of pain. Cumulative data of NPSI scale at end of treatment for both the periods (Period 1 [Week 2] and Period 2 [Week 6]) was calculated and reported in terms of adjusted mean and standard error.	End of treatment period (included both Week 2 and Week 6)
Secondary	Number of Participants With Clinically Significant Vital Signs Abnormalities	Vital signs abnormalities included sitting, standing: systolic, diastolic blood pressure and heart rate. Clinical significance was judged by investigator.	Baseline up to Week 7
Secondary	Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities	Criteria for ECG abnormalities: Maximum QTc (corrected QT) interval, QTcB (Bazett's correction formula) and QTcF (Fridericia's correction formula): 450 to less than (<) 480 milliseconds (msec), 480 to <500 msec and greater than equal to (>=) 500 msec; Maximum QTc interval increase from baseline: >=30 to <60 and >=60 (msec); PR interval: >=300 msec and percent change >=25 or 50 percent; QRS complex: percent change >=25 or 50 percent. Clinical significance was judged by investigator.	Baseline up to Week 7
Secondary	Number of Participants With Clinically Significant Laboratory Abnormalities: Hematology	Criteria for hematology abnormalities included Hemoglobin: <0.8*lower limit of normal (LLN) and hematocrit: <0.8*LLN. Clinical significance was judged by investigator.	Baseline up to Week 7
Secondary	Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry	Criteria for clinical chemistry abnormalities included total bilirubin: greater than (>) 1.5*upper limit of normal (ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase: >3.0*ULN; total protein, albumin: <0.8*LLN or >1.2*ULN; blood urea nitrogen, creatinine: >1.3*ULN; uric acid: >1.2*ULN; sodium: <0.95*LLN or >1.05*ULN; potassium, chloride, calcium: <0.9*LLN or >1.1*ULN; creatine kinase: >2.0*ULN. Clinical significance was judged by investigator.	Baseline up to Week 7
Secondary	Number of Participants With Clinically Significant Laboratory Abnormalities: Urinalysis	Urinalysis abnormalities criteria included: urine specific gravity: <1.003 to >1.030; urine pH: <4.5 to >8; urine glucose, urine ketones, urine proteins, urine blood/hemoglobin: >=1. Clinical significance was judged by investigator.	Baseline up to Week 7

External Links

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