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Trial record 87 of 424 for:    Pregabalin

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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Postherpetic Neuralgia
Intervention Drug: pregabalin
Enrollment 9
Recruitment Details A total of 24 participants were screened, of which nine participants at five study centers in the following four countries: Austria (2), Germany (1), South Africa (1) and USA (1) were enrolled and received at least one dose of pregabalin during the study.
Pre-assignment Details This was a Phase 4, open-label, pilot study of pregabalin and prediction of treatment response in post herpetic neuralgia (PHN) participants. The duration of the treatment period was 6 weeks (4 weeks dose optimization +2 weeks fixed dose), with a 1-week taper/placebo washout administered at the end of study.
Arm/Group Title Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)
Hide Arm/Group Description During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
Period Title: Overall Study
Started 9
Completed 8
Not Completed 1
Reason Not Completed
Adverse Event             1
Arm/Group Title Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)
Hide Arm/Group Description During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Age at least 18 years
Number Analyzed 9 participants
9
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
7
  77.8%
Male
2
  22.2%
1.Primary Outcome
Title Change From Baseline in the Daily Pain Diary (Numerical Rating Scale, NRS) Mean Pain Score at the End of the Study (Week 6).
Hide Description 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.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.
Arm/Group Title Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)
Hide Arm/Group Description:
During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Neuropathic Pain Symptom Inventory (NPSI) at All Visits.
Hide Description 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.
Time Frame All visits
Hide Outcome Measure Data
Hide Analysis Population Description
Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.
Arm/Group Title Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)
Hide Arm/Group Description:
During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Proportion of Phenotypes Within the 30% and 50% Responder Groups at Baseline and Week 6.
Hide Description 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.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.
Arm/Group Title Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)
Hide Arm/Group Description:
During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Patient Global Impression of Change (PGIC) at Week 6/Early Termination.
Hide Description 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).
Time Frame Week 6/Early Termination
Hide Outcome Measure Data
Hide Analysis Population Description
Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.
Arm/Group Title Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)
Hide Arm/Group Description:
During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Proportions of Participants With >/=30% and >/=50% Pain Reduction Based on Daily Pain Diary at Baseline and Week 6.
Hide Description 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.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.
Arm/Group Title Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)
Hide Arm/Group Description:
During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title 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.
Hide Description 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.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.
Arm/Group Title Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)
Hide Arm/Group Description:
During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title 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.
Hide Description 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.
Time Frame Screening, Visit 2 (Week 0) and Week 6/Early Termination
Hide Outcome Measure Data
Hide Analysis Population Description
Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.
Arm/Group Title Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)
Hide Arm/Group Description:
During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Brief Pain Inventory (BPI sf) at Visit 2 (Week 0) and Week 6.
Hide Description 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).
Time Frame Visit 2 (Week 0), Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.
Arm/Group Title Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)
Hide Arm/Group Description:
During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Patient Catastrophizing Scale (PCS) at Visit 2 (Week 0) and Week 6.
Hide Description 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).
Time Frame Visit 2 (Week 0), Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.
Arm/Group Title Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)
Hide Arm/Group Description:
During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Pain NRS Score; 1 Week Recall Period.
Hide Description 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.
Time Frame 1 Week
Hide Outcome Measure Data
Hide Analysis Population Description
Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.
Arm/Group Title Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)
Hide Arm/Group Description:
During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Short Form 12v2 Health Survey (SF 12v2) at Visit 2 (Week 0), and Week 6/Early Termination.
Hide Description 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.
Time Frame Visit 2 (Week 0), and Week 6/Early Termination
Hide Outcome Measure Data
Hide Analysis Population Description
Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.
Arm/Group Title Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)
Hide Arm/Group Description:
During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Change From Baseline to End of the Study (Week 6) in the Daily Sleep Interference Diary (NRS) Mean Pain Score.
Hide Description 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.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.
Arm/Group Title Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)
Hide Arm/Group Description:
During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame AEs: The time the participant had taken at least one dose of study treatment through last participant visit. SAEs: The time the participant provides informed consent through and including 28 calendar days after the last administration of study treatment.
Adverse Event Reporting Description The same event may appear as both an adverse event (AE) and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)
Hide Arm/Group Description During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
All-Cause Mortality
Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)
Affected / at Risk (%)
Total   0/9 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)
Affected / at Risk (%)
Total   8/9 (88.89%) 
Gastrointestinal disorders   
Dry mouth * 1  2/9 (22.22%) 
Nausea * 1  1/9 (11.11%) 
General disorders   
Edema peripheral * 1  2/9 (22.22%) 
Fatigue * 1  2/9 (22.22%) 
Infections and infestations   
Upper respiratory tract infection * 1  1/9 (11.11%) 
Musculoskeletal and connective tissue disorders   
Muscle rigidity * 1  1/9 (11.11%) 
Nervous system disorders   
Dizziness * 1  4/9 (44.44%) 
Sedation * 1  1/9 (11.11%) 
Somnolence * 1  1/9 (11.11%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.0
Outcome measure PCS was removed in protocol amendment1. Study stopped due to low enrolment and not safety. Efficacy analyses were not performed; safety results are described. Overall risk-benefit of pregabalin has not changed due to trial termination
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01603394     History of Changes
Other Study ID Numbers: A9001464
First Submitted: April 16, 2012
First Posted: May 22, 2012
Results First Submitted: June 6, 2014
Results First Posted: July 8, 2014
Last Update Posted: July 8, 2014