Adolescent Fibromyalgia Study - Full Text View

Purpose

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.

Condition	Intervention	Phase
Fibromyalgia	Drug: placebo Drug: pregabalin (Lyrica)	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A 15 Week, Randomized, Double Blind, Parallel-group, Placebo-controlled, Flexible-dose, Safety And Efficacy Study Of Pregabalin In Adolescents (12-17 Years Old) With Fibromyalgia

Resource links provided by NLM:

MedlinePlus related topics: Fibromyalgia

Drug Information available for: Pregabalin

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change From Baseline to Week 15 in Mean Pain Diary Score [ Time Frame: Week 15 ] [ Designated as safety issue: No ]
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").

Secondary Outcome Measures:

Change From Baseline to Week 15 in Mean Sleep Quality Diary Score [ Time Frame: Week 15 ] [ Designated as safety issue: No ]
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".
Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS) [ Time Frame: Baseline to Week 15 ] [ Designated as safety issue: No ]
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).
Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS) [ Time Frame: Baseline to Week 15 ] [ Designated as safety issue: No ]
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".
Change From Baseline to Week 15 in Mean Pain Numeric Rating Scale (1 Week Recall Period) [ Time Frame: Week 15 ] [ Designated as safety issue: No ]
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.
Proportion of 30% Responders in Weekly Mean Pain Score (NRS) at Week 15 [ Time Frame: Week 15 ] [ Designated as safety issue: No ]
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).
Proportion of 50% Responder in Weekly Mean Pain Score (NRS) at Week 15 [ Time Frame: Week 15 ] [ Designated as safety issue: No ]
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).
Proportion of Patient Global Impression Change (PGIC) at Week 15 [ Time Frame: Week 15 ] [ Designated as safety issue: No ]
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).


Enrollment:	107
Study Start Date:	May 2010
Study Completion Date:	December 2014
Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo	Drug: placebo matching placebo capsules twice daily.
Experimental: drug-pregabalin	Drug: pregabalin (Lyrica) 75-450mg/day pregabalin dose optimised at start of study

Eligibility


Ages Eligible for Study:	12 Years to 17 Years (Child)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of fibromyalgia
12-17 years of age

Exclusion Criteria:

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01020474

Show 36 Study Locations

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site


Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01020474 History of Changes
Other Study ID Numbers:	A0081180 2010-019521-34
Study First Received:	November 23, 2009
Results First Received:	May 26, 2015
Last Updated:	June 22, 2015
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:


juvenile primary fibromyalgia syndrome pediatric fibromyalgia pregabalin and Lyrica

Additional relevant MeSH terms:


Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases Pregabalin Analgesics Sensory System Agents	Peripheral Nervous System Agents Physiological Effects of Drugs Anticonvulsants Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs

ClinicalTrials.gov processed this record on September 28, 2016