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CompletedNCT01020474Updated Jan 28, 2021Results posted

Adolescent Fibromyalgia Study

A Phase 4 interventional study of placebo and pregabalin (Lyrica) in Fibromyalgia, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Completed at 36 sites in 4 countries. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2021-01-28.

Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
107
Allocation
Randomized
Ages
12 Years to 17 Years
Sex
All
01

Study summary

This study will compare pregabalin with placebo over a 15 week period in adolescents with fibromyalgia aged 12-17 years to evaluate the safety and efficacy of pregabalin.

02

Conditions studied

  • Fibromyalgia

Keywords

  • juvenile primary fibromyalgia syndrome
  • pediatric fibromyalgia
  • pregabalin
  • and Lyrica
03

In context

Fibromyalgia

1,336 studies on the registry are indexed under Fibromyalgia; 266 are open to participants now.

This study's enrollment of 107 is above the median of 60 across 1,035 interventional studies indexed under Fibromyalgia.

Browse Fibromyalgia studies →

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is the lead sponsor of 431 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosis of fibromyalgia
  • 12-17 years of age

Exclusion criteria

Exclusion Criteria:

  • Patients with other pain conditions
  • Previous treatment with pregabalin
  • Patients taking excluded medication
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
107 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Drug: placebo

  • Experimental
    drug-pregabalin

    Drug: pregabalin (Lyrica)

Interventions

  • Drugplacebo

    matching placebo capsules twice daily.

  • Drugpregabalin (Lyrica)

    75-450mg/day pregabalin dose optimised at start of study

06

What researchers measure

Primary outcomes

  1. Change From Baseline to Week 15 in Mean Pain Diary Score

    The Primary Endpoint is based on the daily pain diary, and is defined as change from baseline to Week 15 in mean pain diary score. The daily pain diary consists of an 11-point numeric rating scale ranging from zero (no pain) to 10 (worst possible pain). The patients rate their pain during the past 24 hours by choosing the appropriate number between 0 ("no pain") and 10 ("worst possible pain").

    Time frame: Week 15

Secondary outcomes

  1. Change From Baseline to Week 15 in Mean Sleep Quality Diary Score

    Change from Baseline to endpoint in mean sleep quality score from the daily sleep diary, defined as the mean of the last 7 diary entries prior to Visit 10 in the study while the participant is on study medication. The daily quality of sleep diary consists of an 11-point numeric rating scale with which the patient rates the quality of their sleep during the past 24 hours. Zero indicates "best possible sleep" and 10 indicates "worst possible sleep".

    Time frame: Week 15

  2. Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS)

    Mean pain score was calculated for each week during the double-blind treatment phase (Week 1 to Week 15). For each week, only days up to the last day on study medication were considered. A minimum of 4 pain diaries were required to calculate the mean pain score. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain).

    Time frame: Baseline to Week 15

  3. Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS)

    Mean sleep quality score was calculated for each week during the double-blind treatment phase (Week 1 to Week 15). A minimum of 4 sleep diaries are required to calculate the mean pain score. The daily quality of sleep diary consists of an 11-point numeric rating scale with which the patient rates the quality of their sleep during the past 24 hours. Zero indicates "best possible sleep" and 10 indicates "worst possible sleep".

    Time frame: Baseline to Week 15

  4. Change From Baseline to Week 15 in Mean Pain Numeric Rating Scale (1 Week Recall Period)

    The weekly pain numeric rating scale (Weekly Pain NRS) consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate greater degree of impairment. Participants choose the number that best describes the pain during the last week.

    Time frame: Week 15

  5. Proportion of 30% Responders in Weekly Mean Pain Score (NRS) at Week 15

    At each visit, participants with at least 30% reduction from Baseline in mean pain score were defined as a 30% responder at the visit. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain).

    Time frame: Week 15

  6. Proportion of 50% Responder in Weekly Mean Pain Score (NRS) at Week 15

    At each visit, participants with at least 50% reduction from Baseline in mean pain score were defined as a 50% responder at the visit. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain).

    Time frame: Week 15

  7. Proportion of Patient Global Impression Change (PGIC) at Week 15

    Responder rates based on PGIC was derived and tabulated by treatment group. A responder was defined as a participant who reports much improved or very much improved. The PGIC is a patient-rated single item that measures patient's perception of change in their overall status since starting study medication on a scale ranging from 1 (very much improved) to 7 (very much worse).

    Time frame: Week 15

07

Results

Posted Jun 25, 2015

Participant flow

A total of 147 participants were screened, 107 participants were randomized to treatment. The 107 randomized participants were recruited in 4 countries at 23 study centers.

Participant flow — Overall Study
MilestonePregabalinPlacebo
Started5453
Completed4436
Not completed1017
Withdrew: Adverse event44
Withdrew: Protocol violation02
Withdrew: Withdrawal by subject57
Withdrew: Other reasons11
Withdrew: Insufficient clinical response03

Outcome measures

PrimaryChange From Baseline to Week 15 in Mean Pain Diary Score

The Primary Endpoint is based on the daily pain diary, and is defined as change from baseline to Week 15 in mean pain diary score. The daily pain diary consists of an 11-point numeric rating scale ranging from zero (no pain) to 10 (worst possible pain). The patients rate their pain during the past 24 hours by choosing the appropriate number between 0 ("no pain") and 10 ("worst possible pain").

Time frame:
Week 15
Reported as:
Least squares mean · Units on a scale
Change From Baseline to Week 15 in Mean Pain Diary Score
Units on a scalePregabalinPlacebo
Change From Baseline to Week 15 in Mean Pain Diary Score-1.60 ± 0.32-0.94 ± 0.31
Statistical analysis
  • Pregabalin vs Placebo · ANCOVA · p = 0.121 (Missing data for week 15 mean pain score are imputed based on distribution of baseline pain scores if participants discontinue due to adverse events/ abnormal laboratory test results or lack of efficacy.) · Mean difference (final values): -0.66 · 95% CI -1.51 to 0.18Based on LS Means using analysis of covariance (ANCOVA) model (including Treatment, Center, Baseline value as covariate).
SecondaryChange From Baseline to Week 15 in Mean Sleep Quality Diary Score

Change from Baseline to endpoint in mean sleep quality score from the daily sleep diary, defined as the mean of the last 7 diary entries prior to Visit 10 in the study while the participant is on study medication. The daily quality of sleep diary consists of an 11-point numeric rating scale with which the patient rates the quality of their sleep during the past 24 hours. Zero indicates "best possible sleep" and 10 indicates "worst possible sleep".

Time frame:
Week 15
Reported as:
Least squares mean · Units on a scale
Change From Baseline to Week 15 in Mean Sleep Quality Diary Score
Units on a scalePregabalinPlacebo
Change From Baseline to Week 15 in Mean Sleep Quality Diary Score-1.13 ± 0.30-0.94 ± 0.31
Statistical analysis
  • Pregabalin vs Placebo · ANCOVA · p = 0.655 · Mean difference (final values): -0.18 · 95% CI -1.00 to 0.63Based on LS Means using analysis of covariance (ANCOVA) model (including Treatment, Center, Baseline value as covariate).
SecondaryMean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS)

Mean pain score was calculated for each week during the double-blind treatment phase (Week 1 to Week 15). For each week, only days up to the last day on study medication were considered. A minimum of 4 pain diaries were required to calculate the mean pain score. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain).

Time frame:
Baseline to Week 15
Reported as:
Least squares mean · Units on a scale
Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS)
Units on a scalePregabalinPlacebo
Week 1 (N= 52, 49)-0.48 ± 0.25-0.41 ± 0.26
Week 2 (N= 54, 47)-1.11 ± 0.25-0.48 ± 0.26
Week 3 (N= 52, 44)-1.27 ± 0.25-0.45 ± 0.26
Week 4 (N= 50, 46)-1.45 ± 0.25-0.55 ± 0.26
Week 5 (N= 49, 44)-1.27 ± 0.25-0.59 ± 0.26
Week 6 (N= 49, 44)-1.47 ± 0.25-0.51 ± 0.27
Week 7 (N= 48, 42)-1.67 ± 0.25-0.77 ± 0.27
Week 8 (N= 46, 44)-1.65 ± 0.25-0.59 ± 0.27
Week 9 (N= 46, 42)-1.61 ± 0.26-0.66 ± 0.27
Week 10 (N= 45, 40)-1.82 ± 0.26-0.85 ± 0.27
Week 11 (N= 44, 38)-1.93 ± 0.26-1.07 ± 0.28
Week 12 (N= 43, 34)-1.75 ± 0.26-0.78 ± 0.28
Week 13 (N= 42, 33)-1.75 ± 0.27-1.01 ± 0.29
Week 14 (N= 41, 34)-2.01 ± 0.27-1.11 ± 0.29
Week 15 (N= 35, 33)-1.90 ± 0.28-1.16 ± 0.30
Statistical analysis
  • Pregabalin vs Placebo · Mixed Models Analysis · p = 0.842 · Mean difference (final values): -0.07 · 95% CI -0.75 to 0.61
  • Pregabalin vs Placebo · Mixed Models Analysis · p = 0.070 · Mean difference (final values): -0.63 · 95% CI -1.32 to 0.05
  • Pregabalin vs Placebo · Mixed Models Analysis · p = 0.019 · Mean difference (final values): -0.83 · 95% CI -1.51 to -0.14
  • Pregabalin vs Placebo · Mixed Models Analysis · p = 0.011 · Mean difference (final values): -0.90 · 95% CI -1.59 to -0.21
  • Pregabalin vs Placebo · Mixed Models Analysis · p = 0.056 · Mean difference (final values): -0.68 · 95% CI -1.38 to 0.02
  • Pregabalin vs Placebo · Mixed Models Analysis · p = 0.008 · Mean difference (final values): -0.96 · 95% CI -1.66 to -0.26
  • Pregabalin vs Placebo · Mixed Models Analysis · p = 0.013 · Mean difference (final values): -0.89 · 95% CI -1.60 to -0.19
  • Pregabalin vs Placebo · Mixed Models Analysis · p = 0.004 · Mean difference (final values): -1.06 · 95% CI -1.77 to -0.35
  • Pregabalin vs Placebo · Mixed Models Analysis · p = 0.009 · Median difference (final values): -0.95 · 95% CI -1.67 to -0.24
  • Pregabalin vs Placebo · Mixed Models Analysis · p = 0.008 · Mean difference (final values): -0.97 · 95% CI -1.69 to -0.25
  • Pregabalin vs Placebo · Mixed Models Analysis · p = 0.021 · Mean difference (final values): -0.86 · 95% CI -1.59 to -0.13
  • Pregabalin vs Placebo · Mixed Models Analysis · p = 0.010 · Mean difference (final values): -0.97 · 95% CI -1.71 to -0.23
  • Pregabalin vs Placebo · Mixed Models Analysis · p = 0.051 · Mean difference (final values): -0.74 · 95% CI -1.49 to 0.00
  • Pregabalin vs Placebo · Mixed Models Analysis · p = 0.020 · Mean difference (final values): -0.90 · 95% CI -1.66 to -0.14
  • Pregabalin vs Placebo · Mixed Models Analysis · p = 0.060 · Mean difference (final values): -0.74 · 95% CI -1.51 to 0.03
SecondaryMean Change From Baseline to Weekly Mean Sleep Quality Score (NRS)

Mean sleep quality score was calculated for each week during the double-blind treatment phase (Week 1 to Week 15). A minimum of 4 sleep diaries are required to calculate the mean pain score. The daily quality of sleep diary consists of an 11-point numeric rating scale with which the patient rates the quality of their sleep during the past 24 hours. Zero indicates "best possible sleep" and 10 indicates "worst possible sleep".

Time frame:
Baseline to Week 15
Reported as:
Least squares mean · Units on a scale
Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS)
Units on a scalePregabalinPlacebo
Week 1 (N= 52, 49)-0.52 ± 0.25-0.30 ± 0.26
Week 2 (N= 54, 47)-0.84 ± 0.25-0.65 ± 0.26
Week 3 (N= 52, 44)-0.89 ± 0.25-0.44 ± 0.26
Week 4 (N= 50, 46)-1.03 ± 0.25-0.54 ± 0.26
Week 5 (N= 49, 44)-0.99 ± 0.25-0.61 ± 0.27
Week 6 (N= 49, 44)-1.18 ± 0.25-0.54 ± 0.27
Week 7 (N= 48, 42)-1.30 ± 0.25-0.81 ± 0.27
Week 8 (N= 46, 44)-1.43 ± 0.25-0.42 ± 0.27
Week 9 (N= 46, 42)-1.38 ± 0.26-0.81 ± 0.27
Week 10 (N= 45, 40)-1.43 ± 0.26-0.66 ± 0.27
Week 11 (N= 44, 38)-1.39 ± 0.26-0.95 ± 0.28
Week 12 (N= 43, 34)-1.38 ± 0.26-0.77 ± 0.28
Week 13 (N= 42, 33)-1.34 ± 0.27-1.00 ± 0.29
Week 14 (N= 41, 34)-1.36 ± 0.27-0.94 ± 0.29
Week 15 (N= 35, 33)-1.25 ± 0.28-1.08 ± 0.30
Statistical analysis
  • Pregabalin vs Placebo · Mixed Models Analysis · p = 0.540 · Mean difference (final values): -0.21 · 95% CI -0.90 to 0.47
  • Pregabalin vs Placebo · Mixed Models Analysis · p = 0.593 · Mean difference (final values): -0.19 · 95% CI -0.87 to 0.50
  • Pregabalin vs Placebo · Mixed Models Analysis · p = 0.206 · Mean difference (final values): -0.44 · 95% CI -1.13 to 0.25
  • Pregabalin vs Placebo · Mixed Models Analysis · p = 0.168 · Mean difference (final values): -0.49 · 95% CI -1.18 to 0.21
  • Pregabalin vs Placebo · Mixed Models Analysis · p = 0.280 · Mean difference (final values): -0.38 · 95% CI -1.08 to 0.32
  • Pregabalin vs Placebo · Mixed Models Analysis · p = 0.075 · Mean difference (final values): -0.64 · 95% CI -1.34 to 0.06
  • Pregabalin vs Placebo · Mixed Models Analysis · p = 0.168 · Mean difference (final values): -0.50 · 95% CI -1.21 to 0.21
  • Pregabalin vs Placebo · Mixed Models Analysis · p = 0.006 · Mean difference (final values): -1.01 · 95% CI -1.73 to -0.30
  • Pregabalin vs Placebo · Mixed Models Analysis · p = 0.120 · Median difference (final values): -0.57 · 95% CI -1.29 to 0.15
  • Pregabalin vs Placebo · Mixed Models Analysis · p = 0.037 · Mean difference (final values): -0.77 · 95% CI -1.49 to -0.05
  • Pregabalin vs Placebo · Mixed Models Analysis · p = 0.246 · Mean difference (final values): -0.43 · 95% CI -1.16 to 0.30
  • Pregabalin vs Placebo · Mixed Models Analysis · p = 0.105 · Mean difference (final values): -0.61 · 95% CI -1.36 to 0.13
  • Pregabalin vs Placebo · Mixed Models Analysis · p = 0.376 · Mean difference (final values): -0.34 · 95% CI -1.09 to 0.41
  • Pregabalin vs Placebo · Mixed Models Analysis · p = 0.285 · Mean difference (final values): -0.41 · 95% CI -1.18 to 0.35
  • Pregabalin vs Placebo · Mixed Models Analysis · p = 0.663 · Mean difference (final values): -0.17 · 95% CI -0.95 to 0.61
SecondaryChange From Baseline to Week 15 in Mean Pain Numeric Rating Scale (1 Week Recall Period)

The weekly pain numeric rating scale (Weekly Pain NRS) consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate greater degree of impairment. Participants choose the number that best describes the pain during the last week.

Time frame:
Week 15
Reported as:
Least squares mean · Units on a scale
Change From Baseline to Week 15 in Mean Pain Numeric Rating Scale (1 Week Recall Period)
Units on a scalePregabalinPlacebo
Change From Baseline to Week 15 in Mean Pain Numeric Rating Scale (1 Week Recall Period)-1.64 ± 0.31-0.77 ± 0.30
Statistical analysis
  • Pregabalin vs Placebo · ANCOVA · p = 0.037 · Mean difference (final values): -0.87 · 95% CI -1.68 to -0.05Based on LS Means using analysis of covariance (ANCOVA) model (including Treatment, Center, Baseline value as covariate).
SecondaryProportion of 30% Responders in Weekly Mean Pain Score (NRS) at Week 15

At each visit, participants with at least 30% reduction from Baseline in mean pain score were defined as a 30% responder at the visit. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain).

Time frame:
Week 15
Reported as:
Number · percentage of participants
Proportion of 30% Responders in Weekly Mean Pain Score (NRS) at Week 15
percentage of participantsPregabalinPlacebo
Proportion of 30% Responders in Weekly Mean Pain Score (NRS) at Week 1542.638.8
Statistical analysis
  • Pregabalin vs Placebo · Regression, Logistic · p = 0.694 · Odds ratio (or): 1.17 · 95% CI 0.53 to 2.58
SecondaryProportion of 50% Responder in Weekly Mean Pain Score (NRS) at Week 15

At each visit, participants with at least 50% reduction from Baseline in mean pain score were defined as a 50% responder at the visit. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain).

Time frame:
Week 15
Reported as:
Number · percentage of participants
Proportion of 50% Responder in Weekly Mean Pain Score (NRS) at Week 15
percentage of participantsPregabalinPlacebo
Proportion of 50% Responder in Weekly Mean Pain Score (NRS) at Week 1520.410.2
Statistical analysis
  • Pregabalin vs Placebo · Regression, Logistic · p = 0.162 · Odds ratio (or): 2.25 · 95% CI 0.72 to 7.02
SecondaryProportion of Patient Global Impression Change (PGIC) at Week 15

Responder rates based on PGIC was derived and tabulated by treatment group. A responder was defined as a participant who reports much improved or very much improved. The PGIC is a patient-rated single item that measures patient's perception of change in their overall status since starting study medication on a scale ranging from 1 (very much improved) to 7 (very much worse).

Time frame:
Week 15
Reported as:
Number · percentage of participants
Proportion of Patient Global Impression Change (PGIC) at Week 15
percentage of participantsPregabalinPlacebo
Very much improved16.32.3
Much improved36.727.3
Minimally improved22.427.3
No change18.438.6
Minimally worse6.12.3
Much worse02.3
Very much worse00
Statistical analysis
  • Pregabalin vs Placebo · Cochran-Mantel-Haenszel · p = 0.013P-value uses the row mean score statistic based on Cochran Mantel Haenszel (CMH) test with modified ridit transformation.

Adverse events

Collected over Adverse events were reported from signing the informed consent until a follow-up visit (Week 16).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Pregabalin—1/54 (1.9%)33/54 (61.1%)
Placebo—0/53 (0%)27/53 (50.9%)
Most frequent serious events
Most frequent serious events
EventPregabalinPlacebo
CholelithiasisHepatobiliary disorders1/540/53
Major depressionPsychiatric disorders1/540/53
Most frequent other events
Showing 10 of 25
Most frequent other events
EventPregabalinPlacebo
DizzinessNervous system disorders16/547/53
NauseaGastrointestinal disorders12/545/53
HeadacheNervous system disorders10/5410/53
Weight increasedInvestigations9/540/53
FatigueGeneral disorders8/544/53
Back painMusculoskeletal and connective tissue disorders3/545/53
SomnolenceNervous system disorders5/542/53
VomitingGastrointestinal disorders3/544/53
Pharyngitis streptococcalInfections and infestations0/544/53
Upper respiratory tract infectionInfections and infestations3/544/53

Baseline characteristics

Age, Continuous
Age, Continuous(years)PregabalinPlaceboTotal
Mean14.6 ± 1.214.7 ± 1.214.7 ± 1.2
Sex: Female, Male
Sex: Female, Male(Participants)PregabalinPlaceboTotal
Female484492
Male6915
08

Study locations

36 sites
  • Childrens Hospital Los Angeles
    Los Angeles, California 90027, United States
  • Apex Research Institute
    Santa Ana, California 92705, United States
  • Eileen Messing, Psy D.
    Delray Beach, Florida 33446, United States
  • Arthritis Associates of South Florida
    Delray Beach, Florida 33484, United States
  • Delray Research Associates
    Delray Beach, Florida 33484, United States
  • Florida Medical Center and Research, Inc.
    Miami, Florida 33142, United States
  • Harmony Clinical Research, Incorporated
    North Miami Beach, Florida 33162, United States
  • Rheumatology Associates of Central Florida, PA
    Orlando, Florida 32806, United States
  • Medical Research & Health Education Foundation, Inc.
    Columbus, Georgia 31909, United States
  • North Georgia Rheumatology, PC
    Lawrenceville, Georgia 30045, United States
  • Kosair Charities Pediatric Clinical Research Unit
    Louisville, Kentucky 40202, United States
  • Kosair Children's Hospital
    Louisville, Kentucky 40202, United States
  • University of Louisville
    Louisville, Kentucky 40202, United States
  • University Pediatric Rheumatology of Kentucky, LLC
    Louisville, Kentucky 40202, United States
  • University of Massachusetts Memorial Medical Center Department of Pediatrics
    Worcester, Massachusetts 01655, United States
  • A&A Pain Institute of St. Louis
    Saint Louis, Missouri 63141, United States
  • Duke University Medical Center
    Durham, North Carolina 27717, United States
  • Duke Medicine Plaza
    Raleigh, North Carolina 27609, United States
  • Akron Children's Hospital
    Akron, Ohio 44308, United States
  • Akron Children's Hospital
    Boardman, Ohio 44512, United States
  • Boardman Medical Pavilion
    Boardman, Ohio 44512, United States
  • University of Cincinnati
    Cincinnati, Ohio 45219, United States
  • Nationwide Children's Hospital
    Columbus, Ohio 43205, United States
  • The Research Institute at Nationwide Children's Hospital
    Columbus, Ohio 43205, United States
  • St. Christopher's Hospital for Children / Section of Rheumatology
    Philadelphia, Pennsylvania 19134-1095, United States
  • Medical University of South Carolina, Pediatric Rheumatology
    Charleston, South Carolina 29425, United States
  • Medical University of South Carolina
    Charleston, South Carolina 29425, United States
  • MUSC University Children's Hospital
    Charleston, South Carolina 29425, United States
  • Carolina Research Center
    Myrtle Beach, South Carolina 29572, United States
  • Fatigue Consultation Clinic
    Salt Lake City, Utah 84102, United States
  • Bioregeneracni a rehabilitacni centrum
    Ricany, 25101, Czechia
  • Krishna Institute of Medical Sciences Ltd
    Secunderabad, Andhra Pradesh 500 003, India
  • Mallikatta Neuro Centre
    Mangalore, Karnataka 575002, India
  • Sushrut Hospital, Research Centre & Post Graduate Institute of Orthopaedics
    Nagpur, Maharashtra 440010, India
  • Department of Physical Medicine & Rehabilitation
    Lucknow, Uttar Pradesh 226 018, India
  • National Taiwan University Hospital
    Taipei, 100, Taiwan
09

References and documents

Publications

  • Arnold LM, Schikler KN, Bateman L, Khan T, Pauer L, Bhadra-Brown P, Clair A, Chew ML, Scavone J; Pregabalin Adolescent Fibromyalgia Study Group. Safety and efficacy of pregabalin in adolescents with fibromyalgia: a randomized, double-blind, placebo-controlled trial and a 6-month open-label extension study. Pediatr Rheumatol Online J. 2016 Jul 30;14(1):46. doi: 10.1186/s12969-016-0106-4. PubMed 27475753 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01020474
Lead sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Responsible party
Sponsor
First posted
Nov 25, 2009
Start date
May 2010
Primary completion
Dec 2014
Completion
Dec 2014
Results posted
Jun 25, 2015
Last update
Jan 28, 2021

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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