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Efficacy Study Measuring the Impact of Pregabalin on Peripheral Neuropathic Pain.

Primary Purpose

Neuropathic Pain

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Pregabalin (Lyrica)
Pregabalin (Lyrica)
Pregabalin (Lyrica)
Placebo
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuropathic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

4

Arm Description

Outcomes

Primary Outcome Measures

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").

Secondary Outcome Measures

Weekly Mean Pain Scores During the Single-blind Treatment Phase
Pain score at Week 0 and Week 4, end of single-bind treatment. Mean of last 7 available pain scores from daily pain diary while on single-blind treatment. A Daily Pain Rating Score : 11- point numerical scale ranging from 0 ("no pain") to 10 ("worst possible pain").
Weekly Mean Pain Scores During the Double Blind Treatment Phase
Mean Pain scores for weeks 4, 5, 6, 7, 8 and 9. Mean of last 7 available pain scores from daily pain diary while on single-blind treatment. A Daily Pain Rating Score : 11-point numerical scale ranging from 0 ("no pain") to 10 ("worst possible pain").
Change in Pain Scores During Double Blind Treatment Phase
Change in Mean Pain score = Mean of last 7 available pain scores from daily pain diary while on single-blind treatment. A Daily Pain Rating Score : 11-point numerical scale ranging from 0 ("no pain") to 10 ("worst possible pain").
Number of Subjects With >= 30% Reduction in Mean Pain Score During Single-blind Treatment
Responders = ≥30% reduction in mean pain score at end of single-blind treatment phase compared to weekly mean pain score at baseline. Mean of last 7 available pain scores from daily pain diary while on single-blind treatment. A Daily Pain Rating Score : 11-point numerical scale ranging from 0 ("no pain") to 10 ("worst possible pain").
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.
Daily Pain Rating Score:11-point numerical scale 0 ("no pain") to 10 ("worst possible pain"). Responders = ≥30% reduction in mean pain score at end of single-blind treatment phase compared to weekly mean pain score at baseline.
Mean Pain Score for Non-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. Daily Pain Rating Score:11-point numerical scale 0 ("no pain") to 10 ("worst possible pain"). Non-Responders = <30% reduction in mean pain score at end of single-blind treatment phase compared to weekly mean pain score at baseline.
Categorized Daily Pain Score
Mean number of days in each pain category. DPRS Daily Pain Rating Score Categories: No pain (score 0), Mild pain (scores 1-3), Moderate pain (scores 4-6), Severe pain (scores 7-10)
Time to Meaningful Increase in Pain During Double-blind Treatment Phase (Number of Participants)
Number of participants who experienced a meaningful increase in pain also includes participants who took rescue medication for pain due to peripheral neuropathic pain or discontinued from the study .
Mean Sleep Interference Score
Mean Sleep Interference (SI) score at end of Double-Blind treatment = mean of last 7 available SI scores from daily SI diary while on Double-Blind treatment. Daily SI rating scale (DSIS) consists of an 11-point numerical scale : Zero means "pain does not interfere with sleep" and 10 means "pain completely interferes with sleep."
Weekly Mean Sleep Interference Scores During the Single-Blind Treatment Phase
Sleep Interference (SI) score at Week 0 and Week 4, end of single-bind treatment. Mean of last 7 available SI scores from daily SI diary while on single-blind treatment. Daily SI rating scale (DSIS) consists of an 11-point numerical scale : Zero means "pain does not interfere with sleep" and 10 means "pain completely interferes with sleep."
Weekly Mean Sleep Interference Scores During the Double Blind Treatment Phase
Mean Sleep Interference scores for weeks 4, 5, 6, 7, 8 and 9. Mean of last 7 available SI scores from daily SI diary while on single-blind treatment. Daily SI rating scale (DSIS) consists of an 11-point numerical scale : Zero means "pain does not interfere with sleep" and 10 means "pain completely interferes with sleep."
Change in Sleep Interference Scores During Double Blind Treatment Phase
Change in Mean SI score: Mean SI score at observation minus mean SI score at week 4. Mean SI Score = mean of last 7 available SI scores from daily SI diary while on single-blind treatment. Daily SI rating scale (DSIS) is 11-point numerical scale : Zero means "pain does not interfere with sleep" and 10 means "pain completely interferes with sleep."
Intensity of Neuropathic Pain -Visual Analog Scale (NeP - VAS)
Change in Scale from randomization to Week 9. Scale to measure Neuropathic Pain -Visual Analog Scale (NeP - VAS): the subject places a mark on the VAS scale (0 to 100) where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.
Change in Hospital Anxiety and Depression Scale Responses
Mean Change from Randomization in Score from Hospital Anxiety and Depression Scale (HADS): 2 subscales, measuring anxiety (HADS-A)and depression (HADS-D). 7 items in each subscale assessed on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). which yields the score ranging 0-21.
Change in Pain Treatment Satisfaction Scale (PTSS)
Mean Change: score from observation minus score from randomization: PTSS "Impact" module of 8-items & "Satisfaction" module of 6-items; item scores 1-5. Mean score for each module transformed onto scale 0- 100, where score 0 =worst possible response and score 100 =best possible response: Score =[(5 - mean non-missing items)*100]/4.
Patient Global Impression of Change (PGIC) Categories by Number of Subjects
Number of subjects that responded to PGIC Categories. PGIC is a subject-rated instrument that measures change in the subject's overall status on a 7-point scale. Scores range from 1 (very much improved) to 7 (very much worse).
Change in Modified Brief Pain Inventory (mBPI) for Pain Interference or Pain Severity.
Mean Change from Randomization: score at mBPI observation minus score at randomization. mBPI is extent to which pain interferes with daily activities on a 0 (no interference) to 10 (completely interfered) scale.
Change in Euro Quality of Life (EQ-5D) Health State Profile and Visual Analog Scale Components
two components to the EQ-5D: a Health State Profile (scores from five domains are used to calculate the utility score :0 refers to dead and a score of 1 refers to perfect health) and a Visual Analogue Scale (VAS) (0 represents the worst imaginable health state and 100 represents the best imaginable health state)

Full Information

First Posted
September 13, 2005
Last Updated
January 20, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00219544
Brief Title
Efficacy Study Measuring the Impact of Pregabalin on Peripheral Neuropathic Pain.
Official Title
A Randomized, Placebo-Controlled Trial of the Efficacy and Safety of Pregabalin in the Treatment of Subjects With Peripheral Neuropathic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Pregabalin (Lyrica)
Intervention Description
pregabalin 150mg/day (75mg BID)
Intervention Type
Drug
Intervention Name(s)
Pregabalin (Lyrica)
Intervention Description
pregabalin 300 mg/day (150mg BID)
Intervention Type
Drug
Intervention Name(s)
Pregabalin (Lyrica)
Intervention Description
pregabalin 600/day (300mg BID)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Neuropathic Pain in Subjects With Peripheral Neuropathic Pain Conditions During the Double-blind Phase
Description
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").
Time Frame
9 weeks
Secondary Outcome Measure Information:
Title
Weekly Mean Pain Scores During the Single-blind Treatment Phase
Description
Pain score at Week 0 and Week 4, end of single-bind treatment. Mean of last 7 available pain scores from daily pain diary while on single-blind treatment. A Daily Pain Rating Score : 11- point numerical scale ranging from 0 ("no pain") to 10 ("worst possible pain").
Time Frame
0 and 4 weeks
Title
Weekly Mean Pain Scores During the Double Blind Treatment Phase
Description
Mean Pain scores for weeks 4, 5, 6, 7, 8 and 9. Mean of last 7 available pain scores from daily pain diary while on single-blind treatment. A Daily Pain Rating Score : 11-point numerical scale ranging from 0 ("no pain") to 10 ("worst possible pain").
Time Frame
Week 4 - 9
Title
Change in Pain Scores During Double Blind Treatment Phase
Description
Change in Mean Pain score = Mean of last 7 available pain scores from daily pain diary while on single-blind treatment. A Daily Pain Rating Score : 11-point numerical scale ranging from 0 ("no pain") to 10 ("worst possible pain").
Time Frame
9 weeks
Title
Number of Subjects With >= 30% Reduction in Mean Pain Score During Single-blind Treatment
Description
Responders = ≥30% reduction in mean pain score at end of single-blind treatment phase compared to weekly mean pain score at baseline. Mean of last 7 available pain scores from daily pain diary while on single-blind treatment. A Daily Pain Rating Score : 11-point numerical scale ranging from 0 ("no pain") to 10 ("worst possible pain").
Time Frame
Week 4 (end of single-blind treatment phase)
Title
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.
Description
Daily Pain Rating Score:11-point numerical scale 0 ("no pain") to 10 ("worst possible pain"). Responders = ≥30% reduction in mean pain score at end of single-blind treatment phase compared to weekly mean pain score at baseline.
Time Frame
Week 4
Title
Mean Pain Score for Non-responders at End of Single-blind Treatment Phase
Description
Change from baseline of mean of last 7 available pain scores from daily pain diary while on single-blind treatment. Daily Pain Rating Score:11-point numerical scale 0 ("no pain") to 10 ("worst possible pain"). Non-Responders = <30% reduction in mean pain score at end of single-blind treatment phase compared to weekly mean pain score at baseline.
Time Frame
Week 4
Title
Categorized Daily Pain Score
Description
Mean number of days in each pain category. DPRS Daily Pain Rating Score Categories: No pain (score 0), Mild pain (scores 1-3), Moderate pain (scores 4-6), Severe pain (scores 7-10)
Time Frame
Week 9
Title
Time to Meaningful Increase in Pain During Double-blind Treatment Phase (Number of Participants)
Description
Number of participants who experienced a meaningful increase in pain also includes participants who took rescue medication for pain due to peripheral neuropathic pain or discontinued from the study .
Time Frame
Week 9
Title
Mean Sleep Interference Score
Description
Mean Sleep Interference (SI) score at end of Double-Blind treatment = mean of last 7 available SI scores from daily SI diary while on Double-Blind treatment. Daily SI rating scale (DSIS) consists of an 11-point numerical scale : Zero means "pain does not interfere with sleep" and 10 means "pain completely interferes with sleep."
Time Frame
Week 9
Title
Weekly Mean Sleep Interference Scores During the Single-Blind Treatment Phase
Description
Sleep Interference (SI) score at Week 0 and Week 4, end of single-bind treatment. Mean of last 7 available SI scores from daily SI diary while on single-blind treatment. Daily SI rating scale (DSIS) consists of an 11-point numerical scale : Zero means "pain does not interfere with sleep" and 10 means "pain completely interferes with sleep."
Time Frame
0 and 4 weeks
Title
Weekly Mean Sleep Interference Scores During the Double Blind Treatment Phase
Description
Mean Sleep Interference scores for weeks 4, 5, 6, 7, 8 and 9. Mean of last 7 available SI scores from daily SI diary while on single-blind treatment. Daily SI rating scale (DSIS) consists of an 11-point numerical scale : Zero means "pain does not interfere with sleep" and 10 means "pain completely interferes with sleep."
Time Frame
Week 9
Title
Change in Sleep Interference Scores During Double Blind Treatment Phase
Description
Change in Mean SI score: Mean SI score at observation minus mean SI score at week 4. Mean SI Score = mean of last 7 available SI scores from daily SI diary while on single-blind treatment. Daily SI rating scale (DSIS) is 11-point numerical scale : Zero means "pain does not interfere with sleep" and 10 means "pain completely interferes with sleep."
Time Frame
9 weeks
Title
Intensity of Neuropathic Pain -Visual Analog Scale (NeP - VAS)
Description
Change in Scale from randomization to Week 9. Scale to measure Neuropathic Pain -Visual Analog Scale (NeP - VAS): the subject places a mark on the VAS scale (0 to 100) where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.
Time Frame
Week 4, Week 9
Title
Change in Hospital Anxiety and Depression Scale Responses
Description
Mean Change from Randomization in Score from Hospital Anxiety and Depression Scale (HADS): 2 subscales, measuring anxiety (HADS-A)and depression (HADS-D). 7 items in each subscale assessed on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). which yields the score ranging 0-21.
Time Frame
Week 9
Title
Change in Pain Treatment Satisfaction Scale (PTSS)
Description
Mean Change: score from observation minus score from randomization: PTSS "Impact" module of 8-items & "Satisfaction" module of 6-items; item scores 1-5. Mean score for each module transformed onto scale 0- 100, where score 0 =worst possible response and score 100 =best possible response: Score =[(5 - mean non-missing items)*100]/4.
Time Frame
Week 9
Title
Patient Global Impression of Change (PGIC) Categories by Number of Subjects
Description
Number of subjects that responded to PGIC Categories. PGIC is a subject-rated instrument that measures change in the subject's overall status on a 7-point scale. Scores range from 1 (very much improved) to 7 (very much worse).
Time Frame
Week 9
Title
Change in Modified Brief Pain Inventory (mBPI) for Pain Interference or Pain Severity.
Description
Mean Change from Randomization: score at mBPI observation minus score at randomization. mBPI is extent to which pain interferes with daily activities on a 0 (no interference) to 10 (completely interfered) scale.
Time Frame
Week 9
Title
Change in Euro Quality of Life (EQ-5D) Health State Profile and Visual Analog Scale Components
Description
two components to the EQ-5D: a Health State Profile (scores from five domains are used to calculate the utility score :0 refers to dead and a score of 1 refers to perfect health) and a Visual Analogue Scale (VAS) (0 represents the worst imaginable health state and 100 represents the best imaginable health state)
Time Frame
Week 9

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2S 3C3
Country
Canada
Facility Name
Pfizer Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 0M3
Country
Canada
Facility Name
Pfizer Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5J 3N4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5N 3Y6
Country
Canada
Facility Name
Pfizer Investigational Site
City
Red Deer
State/Province
Alberta
ZIP/Postal Code
T4N 6V7
Country
Canada
Facility Name
Pfizer Investigational Site
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 2H4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6E 1M7
Country
Canada
Facility Name
Pfizer Investigational Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2E8
Country
Canada
Facility Name
Pfizer Investigational Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2V 4W3
Country
Canada
Facility Name
Pfizer Investigational Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 3P4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3J 3T1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
Pfizer Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Port Hope
State/Province
Ontario
ZIP/Postal Code
L1A 3Y9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Charlottetown
State/Province
Prince Edward Island
ZIP/Postal Code
C1E 1J7
Country
Canada
Facility Name
Pfizer Investigational Site
City
Granby
State/Province
Quebec
ZIP/Postal Code
J2G 8Z9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7M 3L9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7T 2P5
Country
Canada
Facility Name
Pfizer Investigational Site
City
Levis
State/Province
Quebec
ZIP/Postal Code
G6V 3Z1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Mirabel
State/Province
Quebec
ZIP/Postal Code
J7J 2K8
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Sherbrook
State/Province
Quebec
ZIP/Postal Code
J1H 4J6
Country
Canada
Facility Name
Pfizer Investigational Site
City
Ste-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4X7
Country
Canada
Facility Name
Pfizer Investigational Site
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081084&StudyName=Efficacy%20Study%20Measuring%20the%20Impact%20of%20Pregabalin%20on%20Peripheral%20Neuropathic%20Pain.
Description
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Efficacy Study Measuring the Impact of Pregabalin on Peripheral Neuropathic Pain.

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