Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Postherpetic Neuralgia

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.806 enrolled

Overview

The purpose of the study is to explore the safety and efficacy of a new once a day pregabalin formulation versus placebo for patients with post herpetic neuralgia (Shingles)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

806

Conditions

Post Herpetic Neuralgia

Interventions

PregabalinDRUG

Tablets, 82.5 to 660mg, once per day. Duration: 19 weeks

placeboDRUG

Placebo, 82.5 to 660mg, once per day. Duration: 13 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients must have pain present for more than 3 months after the healing of the herpes zoster skin rash. * At screening (V1) and enrollment (V2), patients must have a score of greater than or equal to 4 on the Pain Numeric Rating Scale (1 week recall period). * At enrollment (V2), at least 4 pain diaries must be completed satisfactorily within the last 7 days and the average pain score must be greater than or equal to 4. * Male or female of any race, at least 18 years of age, and using appropriate methods of contraception Exclusion Criteria: * Creatinine clearance \<30 mL/min (estimated from serum creatinine). * Skin conditions in the affected dermatome that could alter sensation * Pregabalin use in the last 30 days. Subjects taking pregabalin in the last 30 days should be washed out of pregabalin for at least 30 days prior to screening visit. Patients who had not responded to pregabalin

Locations (146)

Outcomes

Primary Outcomes

Number of Participants With Loss of Therapeutic Response.

Loss of Therapeutic Response (LTR) is defined as \<30% pain response relative to the single blind phase baseline or patient discontinuation due to lack of efficacy or adverse events in the double blind phase of the study. For the calculation of \<30% pain response relative to baseline, baseline will be defined as the mean of the last 7 observations prior to the start of SB treatment, which will be compared with the 7 days rolling average of pain response in DB phase. Participants may be discontinued due to lack of efficacy in this study at the discretion of the study physician.

Time frame: 13 Weeks

Secondary Outcomes

Participants With Secondary LTR Based on 5 Day Rolling Average Diary Results

A secondary LTR endpoint (S-LTR) was defined as the 5 day rolling average pain score during DB, compared to the 5 day randomization baseline pain score. As a secondary endpoint, S-LTR was defined as: 1. At least a 30% increase in the 5 days rolling average pain score during DB relative to the 5 Day randomization baseline pain score 2. A 5 days rolling average pain score ≥4. Participants who discontinue due to lack of efficacy or adverse events in the DB phase of the study will also be counted as an LTR.

Time frame: 13 Weeks

Percentage of Participants With 30% Reduction in the Mean Pain Score.

The 30% pain responders were defined as participants with at least a 30% reduction in the mean pain score from SB baseline to DB endpoint.

Time frame: 13 Weeks

Percentage of Participants With 50% Reduction in the Mean Pain Score.

The 50% pain responders were defined as participants with at least a 50% reduction in the mean pain score from SB baseline to DB endpoint.

Time frame: 13 Weeks

Change From Baseline to Endpoint in Weekly Mean Pain Score.

Data from ClinicalTrials.gov

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Fundamental Research

Gulf Shores, Alabama, United States

Radiant Research, Inc.

Chandler, Arizona, United States

Elite Clinical Studies, LLC

Phoenix, Arizona, United States

HOPE Research Institute

Phoenix, Arizona, United States

The Pain Center of Arizona

Phoenix, Arizona, United States

The Pain Center of Arizona

Phoenix, Arizona, United States

Genova Clinical Research

Tucson, Arizona, United States

Larry Watkins, M.D. (Private Practice)

Little Rock, Arkansas, United States

Lynn Institute of the Ozarks

Little Rock, Arkansas, United States

Hearne Family Practice Clinic

Little Rock, Arkansas, United States

...and 136 more locations

The pain numeric rating scale (NRS Pain) consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain

Time frame: SB Baseline (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19

Change in the Weekly NRS-Pain (1-Week Recall).

Time frame: SB Baseline (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19

Change in the Medical Outcomes Study-Sleep Scale (MOS-SS).

The MOS-SS is a validated self administered questionnaire consisting of 12 items that assess key constructs of sleep. The scale has been found reliable and valid with good overall measurement properties. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9 item overall sleep problems index assessing sleep over the past week. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute.

Time frame: SB Baseline (BL) (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19

Change in the MOS-SS-Quantity of Sleep.

The MOS-SS is a validated self administered questionnaire consisting of 12 items that assess key constructs of sleep. The scale has been found reliable and valid with good overall measurement properties. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9 item overall sleep problems index assessing sleep over the past week. The item "Quantity of sleep" of MOS-SS is presented here.

Time frame: SB Baseline (BL) (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19

The MOS-SS-Optimal Sleep.

The MOS-SS is a validated self administered questionnaire consisting of 12 items that assess key constructs of sleep. The scale has been found reliable and valid with good overall measurement properties. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9 item overall sleep problems index assessing sleep over the past week. The optimal sleep score is a dichotomous 'Yes' or 'No' rating, where 'Yes' indicates optimal sleep (average 7-8 hours per night) and 'No' indicates not optimal sleep. The "percentage of participants with optimal sleep" is presented here.

Time frame: Week 6 and Week 19

Percentage of Participants With Change in the Patient Global Impression of Change (PGIC) Score

The PGIC is a participant-rated instrument that has been used in chronic pain and fibromyalgia studies to rate change in a patient's overall status. This single item instrument uses a 7 point Likert scale, anchored by (1) very much improved, to (7) very much worse.

Time frame: Week 19

Change in the Short Form 36 Health Survey (SF-36)

The SF 36 is a self administered, validated questionnaire that measures each of the following 8 health aspects: Physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception over the past week. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) where, higher scores indicate a better health related quality of life.

Time frame: Week 19

Change in Mean Daily Sleep Interference Scores

The pain related sleep interference item rating scale is scored on an 11 point numeric rating scale (NRS Sleep). It is self administered by the subject in order to rate how pain has interfered with their sleep during the past 24 hours, ranging from 0 (pain does not interfere with sleep) to 10 (completely interferes (unable to sleep due to pain)). Participants are to describe how their pain has interfered with their sleep during the past 24 hours by choosing the appropriate number on the numeric rating scale.

Time frame: Week 19

Change in Hospital Anxiety and Depression Scales (HADS)

The HADS is a self administered questionnaire that was designed to screen for the presence of a mood disorder in medically ill patients. To distinguish psychiatric presentations from physical illness, the items focus on subjective disturbance of mood rather than physical signs. The HADS contains 14 items rated on 4 point Likert type scales. Two subscales assess depression and anxiety. Each subscale consists of 7 statements, rated on a scale of 0 to 3 (0 = No anxiety or depression, to 3 = Severe feelings of anxiety or depression). Separate scores are calculated for each subscale ranging from 0 to 21. Higher scores denote greater severity of depression or anxiety

Time frame: Week 19

Change in the Brief Pain Inventory (BPI-sf)

The BPI sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. The BPI sf consists of 5 questions. Questions 1, 2, 3, and 4 measure pain on an 11 point scale from 0 (no pain) to 10 (worst pain possible). Question 5 consists of 7 item subsets which measure the level of interference of pain on daily functions on an 11 point scale from 0 (Does not interfere) to 10 (Completely interferes).

Time frame: Week 19

Percentage of Participants With Benefit From Treatment, Satisfaction With Treatment and Willingness to Continue Treatement (BSW)

The BSW is administered by the study physician or designated site personnel and consists of three single item measures designed to capture the patient's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy.

Time frame: Week 19

Number of Participants With Adverse Events

An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. A serious adverse event is any untoward medical occurrence at any dose that: Results in death; Is life-threatening (immediate risk of death); Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); or Results in congenital anomaly/birth defect. The study physician used the adjective "severe" to those AEs that interfere significantly with participant's usual function.

Time frame: Baseline to Week 20

Percentage of Participants With Suicidal Behaviour/Ideation

Percentage of participants with suicidal behavior/ideation were noted as Baseline, Weeks 6, 11, 15, 19 and 20.

Time frame: Baseline, Weeks 6, 11, 15, 19 and 20