Pilot Study Of Pregabalin And Prediction Of Treatment Response In Patients With Postherpetic Neuralgia
This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01603394
First received: April 16, 2012
Last updated: May 12, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The primary objective is to explore whether sensory symptom cluster analysis is useful for predicting treatment response in Postherpetic Neuralgia.
| Condition | Intervention | Phase |
|---|---|---|
|
Postherpetic Neuralgia |
Drug: pregabalin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 4 Multicenter, Open-Label, Pilot Study Of Pregabalin And Prediction Of Treatment Response In Patients With Postherpetic Neuralgia |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- Proportions of subjects with >30% and >50% pain reduction based on daily pain diary. [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
- Proportion of phenotypes within the 30% and 50% responder groups. [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
- Pain numeric rating scale (NRS); 1 week recall period. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- Neuropathic Pain Symptom Inventory (NPSI). [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
- Patient Global Impression of Change (PGIC). [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
- Short Form 12v2 Health Survey (SF 12v2). [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Patient Health Questionnaire-8 (PHQ 8); Generalized Anxiety Disorder-7 (GAD 7). [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
- Patient Catastrophizing Scale (PCS). [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- Brief Pain Inventory (BPI sf). [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
| Enrollment: | 9 |
| Study Start Date: | October 2012 |
| Study Completion Date: | April 2013 |
| Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Pregabalin (300-600 mg/day; 150 mg/day starting dose) |
Drug: pregabalin
Pregabalin Capsules (150 mg - 600mg), Dose titration (4 weeks) and fixed dose (2 weeks) for a 6 week treatment period.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01603394
Locations
| United States, Florida | |
| Pfizer Investigational Site | |
| Leesburg, Florida, United States, 34748 | |
| United States, Kentucky | |
| Pfizer Investigational Site | |
| Lexington, Kentucky, United States, 40509 | |
| United States, Massachusetts | |
| Pfizer Investigational Site | |
| Chestnut Hill, Massachusetts, United States, 02467 | |
| United States, North Carolina | |
| Pfizer Investigational Site | |
| Chapel Hill, North Carolina, United States, 27514 | |
| Pfizer Investigational Site | |
| Raleigh, North Carolina, United States, 27612 | |
| United States, Ohio | |
| Pfizer Investigational Site | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Oregon | |
| Pfizer Investigational Site | |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | |
| Jekintown, Pennsylvania, United States, 19046 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| Arlington, Texas, United States, 76011 | |
| Austria | |
| Pfizer Investigational Site | |
| Senftenberg, A-3541, Austria | |
| Pfizer Investigational Site | |
| Wien, Austria, A-1090 | |
| Pfizer Investigational Site | |
| Wien, Austria, A-1010 | |
| Germany | |
| Pfizer Investigational Site | |
| Berlin, Germany, 14089 | |
| Pfizer Investigational Site | |
| Goeppingen, Germany, 73033 | |
| Pfizer Investigational Site | |
| Mosbach, Germany, 74821 | |
| Pfizer Investigational Site | |
| Muenchen, Germany, 81675 | |
| Pfizer Investigational Site | |
| Schwerin, Germany, 19053 | |
| Ireland | |
| Pfizer Investigational Site | |
| Wexford, Ireland | |
| South Africa | |
| Pfizer Investigational Site | |
| Arcadia, Pretoria, Gauteng, South Africa, 0001 | |
| Pfizer Investigational Site | |
| Mamelodi East, Pretoria, Gauteng, South Africa, 0122 | |
| Pfizer Investigational Site | |
| Pretoria, Gauteng, South Africa, 0122 | |
| Pfizer Investigational Site | |
| Paarl, Western Cape, South Africa, 7626 | |
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: | NCT01603394 History of Changes |
| Other Study ID Numbers: | A9001464 |
| Study First Received: | April 16, 2012 |
| Last Updated: | May 12, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Neuralgia Neuralgia, Postherpetic Pain Neurologic Manifestations Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms Pregabalin |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants |
ClinicalTrials.gov processed this record on May 16, 2013