Extension to the Fibromyalgia Research Study in 12-16 year olds

• Conditions: Adolescent fibromyalgia; MedDRA version: 14.1Level: PTClassification code 10048439Term: FibromyalgiaSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2010-020300-29-CZ
• Lead Sponsor: Pfizer Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-28
• Last Update Posted: 10 June 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
1. Subject and one parent (or legal guardian) must be willing and able to comply with
scheduled visits, treatment plan, laboratory tests, and other study procedures. Study
medication will not be dispensed to a minor; a parent/guardian/caregiver must be
available to pick up study medication for study patient at Visit 1, Visit 5, Visit 7, Visit
9 and Visit 11.
2. Subject and one parent (or legal guardian) must have personally signed and dated a legally effective written informed assent and consent indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study, prior to admission to the study.
3. Patients must have met the inclusion criteria for the preceding fibromyalgia
Study A0081180 (12-16 years old at time of enrollment in A0081180 and have met
the Yunus & Masi criteria for fibromyalgia), have received study medication under
double-blind conditions, and have completed the A0081180 study.
4. Female patients must continue to use adequate birth control methods and have a
negative pregnancy test at open-label Visit 1 [from V10/Termination Visit of the
double-blind protocol] and at the indicated intervals during the open-label study.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects may not participate in the study if they meet any of the following criteria:
1. Patients who 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 the sponsor.
2. Patients with white blood cell (WBC) count <2.5 x 10 to the power of 9/L, neutrophil count
<1.5 x 10 to the power of 9/L, or platelet count <100 x 10 to the power of 9/L on laboratory tests from Visit 10 in Study A0081180.
3. CLcr =80 mL/min (estimated from serum creatinine from Visit 10 in Study A0081180 using Cockcroft-Gault equation).
4. A urine drug screen for non-therapeutic drugs will be performed at Visit 10 in
Study A0081180; subjects testing positive will not be enrolled.
5. Any subjects who are considered at risk of suicide based on the Suicidality Tracking Scale (STS) administered at Visit 1 or likely to self harm, based upon clinical
judgment. In addition, any subjects meeting the suicidality
exclusion criteria in the parent Study A0081180 must be excluded from this study.
6. Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception (or abstinence), as outlined in the Life Style Guidelines, from V1 until completion of follow-up procedures. Male
patients must agree that female spouses/partners will use adequate contraception (as defined in the Life Style Guidelines) or be of non-childbearing potential (ie, surgically sterile).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified