Pregabalin In Adolescent Patients With Fibromyalgia

A 6-MONTH, OPEN-LABEL, SAFETY TRIAL OF PREGABALIN IN ADOLESCENT PATIENTS WITH FIBROMYALGIA - Not applicable

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/006072

Enrollment

162

Registered

2011-01-04

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 Oral capsule 75-450 mg/day Control Intervention1: Not Applicable: Not applicable

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients must have met the inclusion criteria for the preceding fibromyalgia Study A0081180, and have received pregabalin/placebo under double-blind conditions.

Exclusion criteria

Exclusion criteria: 1. Patients may not participate in the study if they experienced a serious adverse event during the previous fibromyalgia study A0081180 which was determined to be related to the study medication by the investigator or sponsor.

Design outcomes

Primary

Measure	Time frame
Primary Efficacy Endpoint- Pain Numeric Rating Scale (NRS)Timepoint: 6 month	—

Secondary

Measure	Time frame
Not applicableTimepoint: Not applicable	—

Countries

Czech Republic, India, 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