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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01270828
First received: January 4, 2011
Last updated: December 8, 2015
Last verified: December 2015
  Purpose
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)

Condition Intervention Phase
Post Herpetic Neuralgia
Drug: Pregabalin
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3 Double-blind, Randomized, Placebo-controlled, Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Postherpetic Neuralgia (Protocol A0081224)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With Loss of Therapeutic Response. [ Time Frame: 13 Weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Participants With Secondary LTR Based on 5 Day Rolling Average Diary Results [ Time Frame: 13 Weeks ] [ Designated as safety issue: No ]

    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.

  • Percentage of Participants With 30% Reduction in the Mean Pain Score. [ Time Frame: 13 Weeks ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With 50% Reduction in the Mean Pain Score. [ Time Frame: 13 Weeks ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline to Endpoint in Weekly Mean Pain Score. [ Time Frame: SB Baseline (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19 ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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. Participants were asked to rate their pain over the past week.

  • Change in the Medical Outcomes Study-Sleep Scale (MOS-SS). [ Time Frame: SB Baseline (BL) (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19 ] [ Designated as safety issue: No ]
    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.

  • Change in the MOS-SS-Quantity of Sleep. [ Time Frame: SB Baseline (BL) (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19 ] [ Designated as safety issue: No ]

    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.


  • The MOS-SS-Optimal Sleep. [ Time Frame: Week 6 and Week 19 ] [ Designated as safety issue: No ]

    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.


  • Percentage of Participants With Change in the Patient Global Impression of Change (PGIC) Score [ Time Frame: Week 19 ] [ Designated as safety issue: No ]
    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.

  • Change in the Short Form 36 Health Survey (SF-36) [ Time Frame: Week 19 ] [ Designated as safety issue: No ]
    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.

  • Change in Mean Daily Sleep Interference Scores [ Time Frame: Week 19 ] [ Designated as safety issue: No ]
    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.

  • Change in Hospital Anxiety and Depression Scales (HADS) [ Time Frame: Week 19 ] [ Designated as safety issue: No ]
    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

  • Change in the Brief Pain Inventory (BPI-sf) [ Time Frame: Week 19 ] [ Designated as safety issue: No ]
    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).

  • Percentage of Participants With Benefit From Treatment, Satisfaction With Treatment and Willingness to Continue Treatement (BSW) [ Time Frame: Week 19 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Adverse Events [ Time Frame: Baseline to Week 20 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Suicidal Behaviour/Ideation [ Time Frame: Baseline, Weeks 6, 11, 15, 19 and 20 ] [ Designated as safety issue: Yes ]
    Percentage of participants with suicidal behavior/ideation were noted as Baseline, Weeks 6, 11, 15, 19 and 20.


Enrollment: 806
Study Start Date: March 2011
Study Completion Date: November 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pregablain CR tablet 82.5 to 660mg Drug: Pregabalin
Tablets, 82.5 to 660mg, once per day. Duration: 19 weeks
Placebo Comparator: Placebo Drug: placebo
Placebo, 82.5 to 660mg, once per day. Duration: 13 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01270828

  Show 146 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01270828     History of Changes
Other Study ID Numbers: A0081224  2009-016766-86 
Study First Received: January 4, 2011
Results First Received: October 1, 2015
Last Updated: December 8, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Control Release Pregabalin in Post Herpetic Neuralgia

Additional relevant MeSH terms:
Neuralgia
Neuralgia, Postherpetic
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Pain
Peripheral Nervous System Diseases
Signs and Symptoms
Pregabalin
Analgesics
Anticonvulsants
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 04, 2016