Clinical trial NCT00141219: Pregabalin Peripheral Neuropathic Pain Study
Official title: A 10-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pregabalin (150 mg - 600 mg/Day) Using a Flexible, Optimized Dose Schedule in Subjects With Peripheral Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Neuropathies
Neuralgia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-01
Enrollment: 241
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy of pregabalin, using a flexible, optimized dose schedule with dose adjustment based on Daily Pain Rating Scale (DPRS), compared to placebo in subjects with peripheral neuropathic pain.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of peripheral neuropathic pain syndrome, including diabetic peripheral neuropathy (DPN), postherpetic neuralgia (PHN), or post-traumatic neuropathic pain (including post-surgical), confirmed by a qualified pain specialist.
* Subjects must have completed at least 4 daily pain diaries during the 7 days prior to Visit 2 and have an average pain score of ≥4 over the 7 days prior to Visit 2 (randomization).

Exclusion Criteria:

* Neurologic disorders unrelated to DPN, PHN, or post-traumatic neuropathic pain (including post-surgical), that may confuse or confound the assessment of neuropathic pain.
* Presence of any severe pain associated with conditions other than DPN, PHN, or post-traumatic neuropathic pain (including post-surgical) that may confound the assessment or self evaluation of the pain due to DPN, PHN, or post-traumatic neuropathic pain (including post-surgical).
* Creatinine clearance \< 30 mL/min (estimated from serum creatinine, body weight, age, and sex using the Cockcroft and Gault equation in Appendix E). Maximum dose for subjects with creatinine clearance of 30 to 60 mL/min is 300 mg/day

Primary outcomes:
measure: Daily Pain Rating Scale (DPRS)- Mean Pain Score (ITT Population)
timeFrame: Endpoint- Week 8 or Early Discontinuation
Secondary outcomes:
measure: Daily Pain Rating Scale (DPRS)- Number of 30% Responders (With Respect to Pain Scores)
timeFrame: Endpoint- Week 8 or Early Discontinuation
measure: Daily Pain Rating Scale (DPRS)- Number of 50% Responders (With Respect to Pain Scores)
timeFrame: Endpoint- Week 8 or Early Discontination
measure: Daily Pain Rating Scale (DPRS)- Weekly Mean Pain Score
timeFrame: Weeks 1 to 8
measure: Duration Adjusted Average Change (DAAC) of (Adjusted) Mean Pain Score
timeFrame: Weeks 1 to 8
measure: Mean Sleep Interference Score Based on Daily Sleep Interference Scale (DSIS).
timeFrame: Endpoint- Week 8 or Early Discontinuation
measure: Mean Sleep Score as Computed by DSIS.
timeFrame: Weeks 1 to 8
measure: Medical Outcome Study (MOS) Sleep Disturbance
timeFrame: Week 8
measure: Medical Outcome Study (MOS) Snoring Score
timeFrame: Week 8
measure: Medical Outcome Study (MOS) Awaken Short of Breath or Headache
timeFrame: Week 8
measure: Medical Outcome Study (MOS) Sleep Quantity
timeFrame: Week 8
measure: Medical Outcome Study (MOS) Optimal Sleep: Number of Participants With Optimal Sleep
timeFrame: Week 8
measure: Medical Outcome Study (MOS) Sleep Adequacy
timeFrame: Week 8
measure: Medical Outcome Study (MOS) Somnolence
timeFrame: Week 8
measure: Medical Outcome Study (MOS) Overall Sleep Problems Index
timeFrame: Week 8
measure: Euro Quality of Life (QOL) (EQ-5D) Utility Score
timeFrame: Week 8
measure: Euro Quality of Life (EQ-5D) Visual Analog Scale (VAS)
timeFrame: Week 8
measure: Hospital Anxiety and Depression Scale- Anxiety (HADS-A) Score
timeFrame: Week 8
measure: Hospital Anxiety and Depression Scale- Depression (HADS-D) Score
timeFrame: Week 8
measure: Patient Global Impression of Change (PGIC)
timeFrame: Week 8
measure: Clinical Global Impression of Change (CGIC)
timeFrame: Week 8
measure: Duration Adjusted Average Change (DAAC) of (Unadjusted) Mean Pain Score
timeFrame: Weeks 1 to 8
Other outcomes:
measure: Daily Pain Rating Scale (DPRS)- Mean Pain Scores (Evaluable Population)
timeFrame: Endpoint- Week 8 or Early Discontinuation
Locations:
city: Sungnam-si
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Gyeonggi-do
city: Suwonsi
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Gyeonggi-do
city: Busan
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Daegu
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Gwangju
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: