Phase 4
N=107
Adolescent Fibromyalgia Study
Fibromyalgia
Bottom Line
View on ClinicalTrials.gov: NCT01020474 ↗Enrolled (actual)
107
Serious AEs
0.9%
Results posted
Jun 2015
Primary outcome: Primary: Change From Baseline to Week 15 in Mean Pain Diary Score — -1.60; -0.94 Units on a scale — p=0.121
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- placebo (Drug); pregabalin (Lyrica) (Drug)
- Age
- Pediatric · 12+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 15 in Mean Pain Diary Score |
-1.60; -0.94 | 0.121 |
| SECONDARY Change From Baseline to Week 15 in Mean Sleep Quality Diary Score |
-1.13; -0.94 | 0.655 |
| SECONDARY Mean Change From Baseline to Weekly Mean Pain Score - Daily Pain Numeric Rating Scale (NRS) |
-0.48; -0.41; -1.11; -0.48; -1.27; -0.45 | 0.842 |
| SECONDARY Mean Change From Baseline to Weekly Mean Sleep Quality Score (NRS) |
-0.52; -0.30; -0.84; -0.65; -0.89; -0.44 | 0.540 |
| SECONDARY Change From Baseline to Week 15 in Mean Pain Numeric Rating Scale (1 Week Recall Period) |
-1.64; -0.77 | 0.037 sig |
| SECONDARY Proportion of 30% Responders in Weekly Mean Pain Score (NRS) at Week 15 |
42.6; 38.8 | 0.694 |
| SECONDARY Proportion of 50% Responder in Weekly Mean Pain Score (NRS) at Week 15 |
20.4; 10.2 | 0.162 |
| SECONDARY Proportion of Patient Global Impression Change (PGIC) at Week 15 |
16.3; 2.3; 36.7; 27.3; 22.4; 27.3 | 0.013 sig |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01020474). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.