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Trial record 1 of 1 for:    NCT01603394
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Pilot Study Of Pregabalin And Prediction Of Treatment Response In Patients With Postherpetic Neuralgia

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ClinicalTrials.gov Identifier: NCT01603394
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : May 22, 2012
Results First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE April 16, 2012
First Posted Date  ICMJE May 22, 2012
Results First Submitted Date  ICMJE June 6, 2014
Results First Posted Date  ICMJE July 8, 2014
Last Update Posted Date July 8, 2014
Study Start Date  ICMJE October 2012
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2014)
Change From Baseline in the Daily Pain Diary (Numerical Rating Scale, NRS) Mean Pain Score at the End of the Study (Week 6). [ Time Frame: Baseline, Week 6 ]
The numeric rating scale for pain (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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 18, 2012)
The change in the daily pain diary (Numerical Rating Scale, NRS) mean pain score at the end of the study (Week 6) compared with baseline. [ Time Frame: Baseline, Week 6 ]
Change History Complete list of historical versions of study NCT01603394 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2014)
  • Neuropathic Pain Symptom Inventory (NPSI) at All Visits. [ Time Frame: All visits ]
    NPSI: participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.
  • Proportion of Phenotypes Within the 30% and 50% Responder Groups at Baseline and Week 6. [ Time Frame: Baseline, Week 6 ]
    To explore whether sensory symptom cluster analysis is useful for predicting treatment response in paticipants with PHN, identification of the phenotype was initially required of all participants using three different approaches (with or without the baseline PHQ-8, GAD-7 Pain Related Sleep Interference Score Scale, PCS): 1. PainDETECT at baseline, 2. PainPREDICT at baseline, 3. NPSI at baseline. Then for each of the above phenotypes the distribution of the pregabalin responders (using 30% and 50%) were to be compared.
  • Patient Global Impression of Change (PGIC) at Week 6/Early Termination. [ Time Frame: Week 6/Early Termination ]
    PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse).
  • Proportions of Participants With >/=30% and >/=50% Pain Reduction Based on Daily Pain Diary at Baseline and Week 6. [ Time Frame: Baseline, Week 6 ]
    The daily pain diary consists of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants describe their pain during the previous 24 hours by choosing the appropriate number between 0 and 10. Self-assessment is performed daily at bedtime on a telephone via interactive voice response system (IVRS). The endpoint mean pain score is defined as the mean of the last 7 daily diary pain ratings while taking study medication in the open-label phase. Daily pain IVRS diaries were completed daily at bedtime from Visit 1 (Screening) through Visit 7/Early Termination. Participants were asked to complete their first IVRS daily at bedtime on the morning after Visit 1.
  • Proportion of Participants Within Each Phenotype Group as Determined by Sensory Symptom Clustering Using the PainPREDICT, PainDETECT and Neuropathic Pain Symptom Inventory at Baseline and Week 6. [ Time Frame: Baseline, Week 6 ]
    To explore whether sensory symptom cluster analysis is useful for predicting treatment response in paticipants with PHN, identification of the phenotype was initially required of all participants using three different approaches (with or without the baseline PHQ-8, GAD-7 Pain Related Sleep Interference Score Scale, PCS): 1. PainDETECT at baseline, 2. PainPREDICT at baseline, 3. NPSI at baseline.
  • Patient Health Questionnaire-8 (PHQ-8) at Baseline and Week 6; Generalized Anxiety Disorder-7 (GAD-7) at Screening, Visit 2 (Week 0) and Week 6/Early Termination. [ Time Frame: Screening, Visit 2 (Week 0) and Week 6/Early Termination ]
    The PHQ-8 is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as 0 (not at all) to 3 (nearly every day). The PHQ-8 is a validated subset of the PHQ-9, which comprises the first 8 items of the measure. The GAD-7 is a 7-item questionnaire that assesses anxiety. Participants respond as to how each item applies to them on a 4 point response scale. The higher the score, the more severe the anxiety.
  • Brief Pain Inventory (BPI sf) at Visit 2 (Week 0) and Week 6. [ Time Frame: Visit 2 (Week 0), Week 6 ]
    The Brief Pain Inventory-Short Form (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).
  • Patient Catastrophizing Scale (PCS) at Visit 2 (Week 0) and Week 6. [ Time Frame: Visit 2 (Week 0), Week 6 ]
    The PCS is a 13-item self report instrument and requires a Grade 6 reading level and has been translated into 12 languages. It instructs participants to reflect on past experience of pain and indicate their experience using a 5-point scale. The PCS was designed for research on catastrophizing and pain experience. Catastrophizing is associated with heightened pain and is "an exaggerated negative mental set brought to bear during actual or anticipated painful experience." It is a multidimensional construct compromising elements of rumination, magnification, and helplessness and its factor structure has been replicated. It has a total score and three subscale scores (score range of 0-52).
  • Pain NRS Score; 1 Week Recall Period. [ Time Frame: 1 Week ]
    The numeric rating scale for pain (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.
  • Short Form 12v2 Health Survey (SF 12v2) at Visit 2 (Week 0), and Week 6/Early Termination. [ Time Frame: Visit 2 (Week 0), and Week 6/Early Termination ]
    The Short-Form 12 Health Survey (SF-12v2) 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. Higher scores indicate a better health-related quality of life.
  • Change From Baseline to End of the Study (Week 6) in the Daily Sleep Interference Diary (NRS) Mean Pain Score. [ Time Frame: Baseline, Week 6 ]
    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 participant 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2012)
  • Proportion of subjects within each phenotype group as determined by sensory symptom clustering using the PainPREDICT, PainDETECT and Neuropathic Pain Symptom Inventory. [ Time Frame: Baseline, Week 6 ]
  • Proportions of subjects with >30% and >50% pain reduction based on daily pain diary. [ Time Frame: Baseline, Week 6 ]
  • Proportion of phenotypes within the 30% and 50% responder groups. [ Time Frame: Baseline, Week 6 ]
  • Pain numeric rating scale (NRS); 1 week recall period. [ Time Frame: Baseline ]
  • Neuropathic Pain Symptom Inventory (NPSI). [ Time Frame: Baseline, Week 6 ]
  • Patient Global Impression of Change (PGIC). [ Time Frame: Week 6 ]
  • Short Form 12v2 Health Survey (SF 12v2). [ Time Frame: Baseline ]
  • The change in the daily sleep interference diary (Numerical Rating Scale, NRS) mean pain score at the end of the study (Week 6) compared with baseline. [ Time Frame: Baseline, Week 6 ]
  • Patient Health Questionnaire-8 (PHQ 8); Generalized Anxiety Disorder-7 (GAD 7). [ Time Frame: Baseline, Week 6 ]
  • Patient Catastrophizing Scale (PCS). [ Time Frame: Baseline ]
  • Brief Pain Inventory (BPI sf). [ Time Frame: Baseline, Week 6 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Study Of Pregabalin And Prediction Of Treatment Response In Patients With Postherpetic Neuralgia
Official Title  ICMJE A Phase 4 Multicenter, Open-Label, Pilot Study Of Pregabalin And Prediction Of Treatment Response In Patients With Postherpetic Neuralgia
Brief Summary The primary objective is to explore whether sensory symptom cluster analysis is useful for predicting treatment response in Postherpetic Neuralgia.
Detailed Description The study was stopped on 26 April 2013 due to feasibility issues (low enrollment) not safety. The overall risk-benefit of Lyrica has not changed at all due to termination of this trial. Only 9 of the 150 patients were enrolled into the trial, so we are unable to get adequate results from this study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Postherpetic Neuralgia
Intervention  ICMJE Drug: pregabalin
Pregabalin Capsules (150 mg - 600mg), Dose titration (4 weeks) and fixed dose (2 weeks) for a 6 week treatment period.
Study Arms  ICMJE Experimental: Pregabalin (300-600 mg/day; 150 mg/day starting dose)
Intervention: Drug: pregabalin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 12, 2013)
9
Original Estimated Enrollment  ICMJE
 (submitted: May 18, 2012)
150
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects must have pain present for more than 3 months after the healing of the herpes zoster skin rash.
  • At screening (V1) and baseline (V2), subjects must have a score of >=4 on the Numeric Rating Scale for Pain (1 week recall period).
  • At baseline (V2), at least 4 pain diaries must be completed satisfactorily within the last 7 days and the average pain score must be >=4.

Exclusion Criteria:

  • Subjects having other severe pain that may confound assessment or self evaluation of the pain due to PHN.
  • Neurolytic or neurosurgical therapy for Postherpetic Neuralgia
  • Skin conditions in the affected dermatome that could alter sensation.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Germany,   South Africa,   United States
Removed Location Countries Ireland
 
Administrative Information
NCT Number  ICMJE NCT01603394
Other Study ID Numbers  ICMJE A9001464
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP