A clinical trial to study the effects of study drug (Pregabalin) comparing with dummy drug in patients with muscular pain.

A 15 Week, Randomized, Double Blind, Parallel-Group, Placebo-Controlled, Flexible-Dose, Safety And Efficacy Study Of Pregabalin In Adolescents (12-16 Years Old) With Fibromyalgia - Not applicable

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/001381

Enrollment

162

Registered

2010-09-16

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Fibromyalgia

Interventions

Intervention1: pregabalin: pregabalin 75-450mg/day pregabalin dose optimized at start of study

Route of Administration : oral

Total duration of therapy : 15 weeks Control Intervention1: Placebo Comparator Intervention Drug: placebo : placebo matching placebo capsules twice daily. Route of Administration : oral

Total duration of therapy : 15 weeks

Eligibility

Inclusion criteria

Inclusion criteria: Ages Eligible for Study:12 Years to 17 Years; Genders Eligible for Study:Both; Accepts Healthy Volunteers:No; 1. Diagnosis of fibromyalgia 2. 12-17 years of age

Exclusion criteria

Exclusion criteria: -Patients with other pain conditions -Previous treatment with pregabalin -Patients taking excluded medication

Design outcomes

Primary

Measure	Time frame
Endpoint mean pain score from daily pain diaryTimepoint: 15 Weeks	—

Secondary

Measure	Time frame
12-Lead Electrocardiogram (ECG).Timepoint: Visit 1 and 10;Endpoint mean sleep quality score from the daily sleep diaryTimepoint: 15 Weeks;Fibromyalgia Impact Questionnaire for Children at Termination VisitTimepoint: 15 Weeks;Frequency and severity of adverse events at every visit.Timepoint: 15 Weeks;Laboratory tests: hematology, chemistry, serum pregnancy, urinalysis.Timepoint: Visits 1, 6, and 10;Pain Numeric Rating Scale (Pain-NRS) at Termination VisitTimepoint: 15weeks;Parent Global Impression of Change at Termination VisitTimepoint: 15 Weeks;Patient Global Impression of Change at TerminationTimepoint: 15weeks;Pharmacokinetic endpoint: A population pharmacokinetic analysis will be performed using the sparse PK samples obtained at V6.Timepoint: week 3;Physical and neurological exams.Timepoint: week 1 and week 15 (Visit 1 and 10 respectively);Reproductive hormone monitoring (females only)Timepoint: Visits 1 and 10;Suicidality Tracking Scale (STS).Timepoint: Visits 1, 2, 6, 8, 9, and 10;Tanner staging-assessment of pubertal status (females only)Timepoint: Visits 1 and 10;Vital signs.Timepoint: Visits 1, 2, 6, 8, 9, and 10	—

Measure

Time frame

12-Lead Electrocardiogram (ECG).Timepoint: Visit 1 and 10;Endpoint mean sleep quality score from the daily sleep diaryTimepoint: 15 Weeks;Fibromyalgia Impact Questionnaire for Children at Termination VisitTimepoint: 15 Weeks;Frequency and severity of adverse events at every visit.Timepoint: 15 Weeks;Laboratory tests: hematology, chemistry, serum pregnancy, urinalysis.Timepoint: Visits 1, 6, and 10;Pain Numeric Rating Scale (Pain-NRS) at Termination VisitTimepoint: 15weeks;Parent Global Impression of Change at Termination VisitTimepoint: 15 Weeks;Patient Global Impression of Change at TerminationTimepoint: 15weeks;Pharmacokinetic endpoint: A population pharmacokinetic analysis will be performed using the sparse PK samples obtained at V6.Timepoint: week 3;Physical and neurological exams.Timepoint: week 1 and week 15 (Visit 1 and 10 respectively);Reproductive hormone monitoring (females only)Timepoint: Visits 1 and 10;Suicidality Tracking Scale (STS).Timepoint: Visits 1, 2, 6, 8, 9, and 10;Tanner staging-assessment of pubertal status (females only)Timepoint: Visits 1 and 10;Vital signs.Timepoint: Visits 1, 2, 6, 8, 9, and 10

—

Countries

Czech Republic, India, Taiwan, United States of America

Contacts

Public ContactSwapnali Raut

Representing Pfizer Limited

Swapnali.raut@pfizer.com91-9821415224

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026