Clinical trial NCT00424372: A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin For Postherpetic Neuralgia
Official title: A LONG-TERM STUDY TO EVALUATE SAFETY AND EFFICACY STUDY OF PREGABALIN IN THE TREATMENT OF POSTHERPETIC NEURALGIA.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neuralgia, Postherpetic
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-01-19
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: To evaluate the safety of the long-term use of pregabalin.


Eligibility criteria: Inclusion Criteria:

* Patients who completed the 13-week treatment of postherpetic neuralgia in Study A0081120.
* Patients must be able to understand and cooperate with study procedures and have signed a written informed consent prior to entering the study.

Exclusion Criteria:

* Patients who experienced serious adverse events in the preceding study (A0081120) that were determined by the investigator or the study sponsor to be causally related to the study medication.
* Patients exhibiting treatment non-compliance in the preceding study (A0081120)

Primary outcomes:
measure: Summary of Adverse Events
timeFrame: 52 weeks
Secondary outcomes:
measure: Short-Form McGill Pain Questionnaire the Efficacy of Change: Sensory Score
timeFrame: 52 weeks
measure: Short-Form McGill Pain Questionnaire the Efficacy of Change: Affective Score
timeFrame: 52 weeks
measure: Short-Form McGill Pain Questionnaire the Efficacy of Change: Total Score
timeFrame: 52 weeks
measure: Short-Form McGill Pain Questionnaire the Efficacy of Change: Present Pain Intensity
timeFrame: 52 weeks
measure: Short-Form McGill Pain Questionnaire the Efficacy of Change: Visual Analog Scale
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: National Hospital Organization Nagoya Medical Center
state: Aichi
city: Urayasu
country: Japan
facility: Kobayashi Clinic
state: Chiba
city: Kasuya-gun
country: Japan
facility: Okabe Hospital
state: Fukuoka
city: Maebashi
country: Japan
facility: Gunma Pain Clinic Hospital
state: Gunma
city: Takasaki
country: Japan
facility: Takasaki Pain Clinic
state: Gunma
city: Asahikawa
country: Japan
facility: Asahikawa Pain Clinic Hospital
state: Hokkaido
city: Asahikawa
country: Japan
facility: Kamui Pain Clinic
state: Hokkaido
city: Sapporo
country: Japan
facility: Sapporo Asabu Clinic
state: Hokkaido
city: Sapporo
country: Japan
facility: Higashi Sapporo Hospital
state: Hokkaido
city: Akashi
country: Japan
facility: Seimei Clinic
state: Hyogo
city: Amagasaki
country: Japan
facility: Uchida Pain Relief Clinic
state: Hyogo
city: Himeji
country: Japan
facility: National Hospital Organization Himeji Medical Center
state: Hyogo
city: Kobe
country: Japan
facility: National Hospital Organization Kobe Medical Center
state: Hyogo
city: Kobe
country: Japan
facility: Nakamura Clinic
state: Hyogo
city: Sagamihara
country: Japan
facility: National Hospital Organization Sagamihara National Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Suzuki Pain Clinic
state: Kanagawa
city: Yokohama
country: Japan
facility: Hajiri Pain Clinic
state: Kanagawa
city: Yokohama
country: Japan
facility: National Hospital Organization Yokohama Medical Center
state: Kanagawa
city: Sendai
country: Japan
facility: Sendai Pain Clinic
state: Miyagi
city: Beppu
country: Japan
facility: Nakamura Hospital
state: Ohita
city: Kawaguchi
country: Japan
facility: Kawaguchi Kogyo General Hospital
state: Saitama
city: Tokorozawa
country: Japan
facility: Kinoshita Clinic
state: Saitama
city: Arakawa-ku
country: Japan
facility: Tokyo Women's Medical University Center East
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital
state: Tokyo
city: Mitaka
country: Japan
facility: Mitaka Pain Clinic
state: Tokyo
city: Nakano-ku
country: Japan
facility: Toriumi Pain Clinic
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Kanto Medical NTT East Corporation
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Naganuma Pain Clinic
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Women's Medical University Hospital
state: Tokyo
city: Fukuoka
country: Japan
facility: Mukai Clinic
city: Fukuoka
country: Japan
facility: KM Pain Clinic
city: Fukushima
country: Japan
facility: Otsuki Sleep Clinic
city: Saitama
country: Japan
facility: Hasumi Pain Clinic
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: