NCT00219544

Brief Summary

This study will measure the impact of treatment with pregabalin in adult men and women who have a diagnosis of peripheral neuropathic pain (pain caused by a primary lesion of the peripheral nervous system such as Diabetic peripheral Neuropathy and Postherpetic Neuralgia).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2005

Geographic Reach
1 country

30 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2005

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

June 2, 2009

Completed
Last Updated

January 22, 2021

Status Verified

November 1, 2018

Enrollment Period

2.3 years

First QC Date

September 13, 2005

Results QC Date

February 13, 2009

Last Update Submit

January 20, 2021

Conditions

Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

  • Neuropathic Pain in Subjects With Peripheral Neuropathic Pain Conditions During the Double-blind Phase

    Pain score end of Double-Blind treatment = mean of last 7 available pain scores from daily pain diary while on Double-Blind treatment. A Daily Pain Rating Score : 11- point numerical scale ranging from 0 ("no pain") to 10 ("worst possible pain").

    9 weeks

Secondary Outcomes (18)

  • Weekly Mean Pain Scores During the Single-blind Treatment Phase

    0 and 4 weeks

  • Weekly Mean Pain Scores During the Double Blind Treatment Phase

    Week 4 - 9

  • Change in Pain Scores During Double Blind Treatment Phase

    9 weeks

  • Number of Subjects With >= 30% Reduction in Mean Pain Score During Single-blind Treatment

    Week 4 (end of single-blind treatment phase)

  • Mean Pain Score for Responders at End of Single-blind Treatment Phase. Change From Baseline of Mean of Last 7 Available Pain Scores From Daily Pain Diary While on Single-blind Treatment.

    Week 4

  • +13 more secondary outcomes

Study Arms (4)

1

EXPERIMENTAL
Drug: Pregabalin (Lyrica)

2

EXPERIMENTAL
Drug: Pregabalin (Lyrica)

3

EXPERIMENTAL
Drug: Pregabalin (Lyrica)

4

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Pregabalin (Lyrica)DRUG

pregabalin 150mg/day (75mg BID)

1
PlaceboDRUG

Placebo

4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects presenting a diagnosis of peripheral neuropathic pain, defined as pain caused by a lesion of the peripheral nervous system manifesting with sensory symptoms and signs, for at least 6 months at screening.
  • At baseline, subjects must have completed at least 4 daily pain diaries and must have a mean weekly pain score equal or greater than 4.

You may not qualify if:

  • Presence of any of the following diagnoses: Cervical or lumbo-sacral radiculopathy; Operated or non-operated chronic low back pain Carpal tunnel syndrome or any other entrapment-related neuropathic pain (defined as pain associated with focal nerve lesion produced by constriction or mechanical distortion of the nerve, within a fibrous or fibro-osseous tunnel, or by a fibrous band) ; Complex regional pain syndrome (type 1 and 2); Fibromyalgia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (30)

Pfizer Investigational Site

Calgary, Alberta, T2N 4N1, Canada

Location

Pfizer Investigational Site

Calgary, Alberta, T2S 3C3, Canada

Location

Pfizer Investigational Site

Calgary, Alberta, T3B 0M3, Canada

Location

Pfizer Investigational Site

Edmonton, Alberta, T5J 3N4, Canada

Location

Pfizer Investigational Site

Edmonton, Alberta, T5N 3Y6, Canada

Location

Pfizer Investigational Site

Red Deer, Alberta, T4N 6V7, Canada

Location

Pfizer Investigational Site

Kelowna, British Columbia, V1Y 2H4, Canada

Location

Pfizer Investigational Site

Vancouver, British Columbia, V6E 1M7, Canada

Location

Pfizer Investigational Site

Vancouver, British Columbia, V6Z 2E8, Canada

Location

Pfizer Investigational Site

Winnipeg, Manitoba, R2V 4W3, Canada

Location

Pfizer Investigational Site

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Pfizer Investigational Site

Winnipeg, Manitoba, R3E 3P4, Canada

Location

Pfizer Investigational Site

Halifax, Nova Scotia, B3J 3T1, Canada

Location

Pfizer Investigational Site

Kingston, Ontario, K7L 2V7, Canada

Location

Pfizer Investigational Site

London, Ontario, N6A 4V2, Canada

Location

Pfizer Investigational Site

Port Hope, Ontario, L1A 3Y9, Canada

Location

Pfizer Investigational Site

Toronto, Ontario, M5G 2N2, Canada

Location

Pfizer Investigational Site

Charlottetown, Prince Edward Island, C1E 1J7, Canada

Location

Pfizer Investigational Site

Granby, Quebec, J2G 8Z9, Canada

Location

Pfizer Investigational Site

Laval, Quebec, H7M 3L9, Canada

Location

Pfizer Investigational Site

Laval, Quebec, H7T 2P5, Canada

Location

Pfizer Investigational Site

Lévis, Quebec, G6V 3Z1, Canada

Location

Pfizer Investigational Site

Mirabel, Quebec, J7J 2K8, Canada

Location

Pfizer Investigational Site

Montreal, Quebec, H3A 2B4, Canada

Location

Pfizer Investigational Site

Montreal, Quebec, H3G 1A4, Canada

Location

Pfizer Investigational Site

Montreal, Quebec, H3T 1E2, Canada

Location

Pfizer Investigational Site

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Pfizer Investigational Site

Sherbrook, Quebec, J1H 4J6, Canada

Location

Pfizer Investigational Site

Ste-Foy, Quebec, G1V 4X7, Canada

Location

Pfizer Investigational Site

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

MeSH Terms

Conditions

Neuralgia

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc
ClinicalTrials.govCallCenter@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

November 1, 2005

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

January 22, 2021

Results First Posted

June 2, 2009

Record last verified: 2018-11

Locations

CA(30)