A 17-Week Trial To Assess Pregabalin For The Treatment Of Nerve Pain Due To Spinal Cord Injury
Tracking Information| Start Date ICMJE | January 2007 |
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| Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) |
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Current Primary Outcome Measures ICMJE
(submitted: November 25, 2009) | Duration Adjusted average change(DAAC)derived from subject's daily pain diary, where pain is measured on an 11-point Numerical Rating Scale (NRS-Pain), observed up to a 17-week period. [ Time Frame: Daily ] [ Designated as safety issue: No ] |
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Original Primary Outcome Measures ICMJE
(submitted: December 4, 2006) | The mean of all post-baseline scores derived from subject's daily pain diary, where pain is measured on an 11-point Numerical Rating Scale (NRS-Pain), observed up to a 15-week period. |
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| Change History | Complete list of historical versions of study NCT00407745 on ClinicalTrials.gov Archive Site |
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Current Secondary Outcome Measures ICMJE
(submitted: April 15, 2008) | - Weekly mean pain score changes from baseline up to 16 weeks [ Time Frame: Daily ] [ Designated as safety issue: No ]
- 30% and 50% responder rates in reduction of pain from baseline up to 16 weeks [ Time Frame: Daily ] [ Designated as safety issue: No ]
- The Patient Global Impression of Change score measured at treatment termination after a treatment period of up to 16 weeks [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
- Weekly mean sleep interference score changes from baseline up to 16 weeks [ Time Frame: Daily ] [ Designated as safety issue: No ]
- The modified Brief Pain Inventory Interference Scale score changes from baseline up to 17 weeks [ Time Frame: Baseline, Week 8,12,16 ] [ Designated as safety issue: No ]
- The Quantitative Assessment of Neuropathic Pain score changes from baseline up to 1 7 weeks [ Time Frame: Baseline and week 16 ] [ Designated as safety issue: No ]
- Endpoint mean sleep interference score [ Time Frame: Daily ] [ Designated as safety issue: No ]
- Neuropathic Pain Symptom Inventory [ Time Frame: Week 0 and Week 17 ] [ Designated as safety issue: No ]
- The Hospital Anxiety and Depression Scale score changes from baseline up to 17 weeks [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
- The Medical Outcomes Study Sleep Scale score changes from baseline up to 16 weeks [ Time Frame: Daily ] [ Designated as safety issue: No ]
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Original Secondary Outcome Measures ICMJE
(submitted: December 4, 2006) | - Weekly mean pain score changes from baseline up to 15 weeks
- 30% and 50% responder rates in reduction of pain from baseline up to 15 weeks
- Weekly mean sleep interference score changes from baseline up to 15 weeks
- The modified Brief Pain Inventory Interference Scale score changes from baseline up to 14 weeks
- The Medical Outcomes Study Sleep Scale score changes from baseline up to 14 weeks
- The Hospital Anxiety and Depression Scale score changes from baseline up to 14 weeks
- The Patient Global Impression of Change score measured at treatment termination after a treatment period of up to 14 weeks
- The Quantitative Assessment of Neuropathic Pain score changes from baseline up to 14 weeks
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Descriptive Information| Brief Title ICMJE | A 17-Week Trial To Assess Pregabalin For The Treatment Of Nerve Pain Due To Spinal Cord Injury |
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| Official Title ICMJE | A 17-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial Of Pregabalin For The Treatment Of Chronic Central Neuropathic Pain After Spinal Cord Injury |
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| Brief Summary | The purpose of this study is to evaluate if pregabalin relieves nerve pain associated with spinal cord injury compared to placebo (pill that contains no active medicine). This study will also evaluate the safety of pregabalin in this patient population. |
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| Detailed Description | |
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| Study Phase | Phase III |
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| Study Type ICMJE | Interventional |
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| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
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| Condition ICMJE | - Neuralgia
- Spinal Cord Injuries
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| Intervention ICMJE | |
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| Study Arms / Comparison Groups | - matched placebo: Placebo Comparator
Intervention: Drug: placebo - pregabalin: Experimental
flexible dosing over 4 weeks followed by 12 weeks maintenance and one week taper period Intervention: Drug: pregabalin
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Recruitment Information| Estimated Enrollment ICMJE | 200 |
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| Estimated Completion Date | June 2011 |
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| Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) |
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| Eligibility Criteria ICMJE | Inclusion Criteria: - Subjects with nerve pain after Spinal cord injury (traumatic, diving, ischemic and after removal of benign tumors (except meningioma and fibromas)
- Pain has to be chronic(continuous for at least 3 months or intermittent for at least 6 months
- Pain score at least 4 in 4 of 7 days prior to receive treatment.
Exclusion Criteria: - Pregabalin use in the last 60 days, prior intolerance to pregabalin
- Creatinine clearance <60 mL/min.
- White blood cell count <2500/mm3; neutrophil count <1500/mm3; platelet count <100 x 103/ mm3.
- Abuse of drugs or alcohol
- Unstable medial conditions
- Clinically significant abnormal electrocardiogram (ECG).
- Presence of severe pain associated with conditions other than spinal cord injury that could confound the assessment or self-evaluation of pain due to spinal cord injury.
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| Gender | Both |
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| Ages | 18 Years and older |
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| Accepts Healthy Volunteers | No |
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| Contacts ICMJE | | Contact: Pfizer CT.gov Call Center | 1-800-718-1021 | | |
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| Location Countries ICMJE | United States, Chile, Colombia, Czech Republic, Hong Kong, India, Philippines, Russian Federation |
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Administrative Information| NCT ID ICMJE | NCT00407745 |
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| Responsible Party | Director, Clinical Trials Disclosure Group, Pfizer, Inc |
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| Study ID Numbers ICMJE | A0081107 |
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| Study Sponsor ICMJE | Pfizer |
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| Collaborators ICMJE | |
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| Investigators ICMJE | | Study Director: | Pfizer CT.gov Call Center | Pfizer | |
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| Information Provided By | Pfizer |
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