Fibromyalgia of Less Than One Year Duration. Study of Pregabalin

NCT01397006 | Withdrawn Phase 4

• 1 other identifier: N11-507
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate whether pregabalin is effective in treating subjects who have had fibromyalgia for less than one year. Pregabalin has been approved by the FDA for treatment of fibromyalgia. the purpose of the study is to see if subjects identified through their primary care physicians who have fibromyalgia and have had symptoms for less than one year respond to pregabalin and to identify characteristics of that response.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; pregabalin; Lyrica

Outcome Measures

Primary Outcomes (1)

• Change in pain VAS from study entry to end of study

  12 weeks

Secondary Outcomes (4)

• Change in total score FIQ from study entry to last visit.

  12 weeks

• Change in total score FM 2010 Clinical Scale from study entry to last visit.

  12 Weeks

• Change in PGIC from study entry to last visit.

  12 weeks

• Change in total score for HRQOL from study entry to last visit.

  12 Weeks

Study Arms (2)

Pregabalin

EXPERIMENTAL

Drug: Pregabalin

Placebo

PLACEBO COMPARATOR

Drug: Pregabalin

Interventions

Pregabalin DRUG

Pregabalin dose escalating every 2 weeks. Starting dose is 75 mg. Titrated up to maximum of 450mg

Also known as: Lyrica

Placebo; Pregabalin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet the 2010 ACR criteria for diagnosis of fibromyalgia (See Appendix)
• Meet the 1990 ACR criteria for the classification of fibromyalgia (See Appendix)
• Patients have a pain VAS \> 4
• Patients are able to understand and sign informed consent
• Patients are able to understand and complete study questionnaires
• Patients are prepared to discontinue all pain medications including non-steroidal anti-inflammatory drugs (NSAIDs), and medications for sleep or mood disturbances two weeks prior to beginning the study. Acetaminophen, up to 2 extra-strength, three times daily, will be allowed for break-through pain. Medication use will be surveyed at each visit (See Appendix).
• Age - \> 18
• Females with no documented evidence of current pregnancy, and willingness to take the necessary precautions to prevent pregnancy for the duration of the study period

You may not qualify if:

• Patients with a significant musculoskeletal or rheumatic disorder that may confuse the diagnosis
• Any subject with suicidal thoughts in the past or currently
• Patient with a history of renal disease, heart disease, bleeding problems or low platelet counts
• Women who are breast feeding
• Men or women who plan to have children during the course of the study
• Unable to discontinue any medications prescribed for pain, other than acetaminophen, or any medications for sleep or mood disturbances for at least 2 weeks before the study
• Unable to discontinue any mediations used for sleep disturbances
• Patients currently being treated for any psychiatric illness including depression or anxiety disorder
• Patients currently taking antidepressant, anti-anxiety, or antipsychotic medications.
• Inability to understand and sign informed consent and complete questionnaires.

Sponsors & Collaborators

• Newton-Wellesley Hospital: lead
• Pfizer: collaborator

Study Sites (1)

Newton-Wellesley Hospital

Newton, Massachusetts, 02462, United States

Location

Related Publications (11)

• Goldenberg DL. Fibromyalgia syndrome a decade later: what have we learned? Arch Intern Med. 1999 Apr 26;159(8):777-85. doi: 10.1001/archinte.159.8.777.

  PMID: 10219923 BACKGROUND

• Clauw DJ, Crofford LJ. Chronic widespread pain and fibromyalgia: what we know, and what we need to know. Best Pract Res Clin Rheumatol. 2003 Aug;17(4):685-701. doi: 10.1016/s1521-6942(03)00035-4.

  PMID: 12849719 BACKGROUND

• Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, Tugwell P, Campbell SM, Abeles M, Clark P, et al. The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Report of the Multicenter Criteria Committee. Arthritis Rheum. 1990 Feb;33(2):160-72. doi: 10.1002/art.1780330203.

  PMID: 2306288 BACKGROUND

• Goldenberg DL. Introduction: fibromyalgia and its related disorders. J Clin Psychiatry. 2008;69 Suppl 2:4-5. No abstract available.

  PMID: 18537456 BACKGROUND

• Goldenberg DL. Pharmacological treatment of fibromyalgia and other chronic musculoskeletal pain. Best Pract Res Clin Rheumatol. 2007 Jun;21(3):499-511. doi: 10.1016/j.berh.2007.02.012.

  PMID: 17602996 BACKGROUND

• Goldenberg DL. Fibromyalgia syndrome. An emerging but controversial condition. JAMA. 1987 May 22-29;257(20):2782-7. doi: 10.1001/jama.257.20.2782.

  PMID: 3553636 RESULT

• Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010 May;62(5):600-10. doi: 10.1002/acr.20140.

  PMID: 20461783 RESULT

• Crofford LJ, Rowbotham MC, Mease PJ, Russell IJ, Dworkin RH, Corbin AE, Young JP Jr, LaMoreaux LK, Martin SA, Sharma U; Pregabalin 1008-105 Study Group. Pregabalin for the treatment of fibromyalgia syndrome: results of a randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2005 Apr;52(4):1264-73. doi: 10.1002/art.20983.

  PMID: 15818684 RESULT

• Mease PJ, Russell IJ, Arnold LM, Florian H, Young JP Jr, Martin SA, Sharma U. A randomized, double-blind, placebo-controlled, phase III trial of pregabalin in the treatment of patients with fibromyalgia. J Rheumatol. 2008 Mar;35(3):502-14. Epub 2008 Feb 15.

  PMID: 18278830 RESULT

• Crofford LJ, Mease PJ, Simpson SL, Young JP Jr, Martin SA, Haig GM, Sharma U. Fibromyalgia relapse evaluation and efficacy for durability of meaningful relief (FREEDOM): a 6-month, double-blind, placebo-controlled trial with pregabalin. Pain. 2008 Jun;136(3):419-431. doi: 10.1016/j.pain.2008.02.027. Epub 2008 Apr 8.

  PMID: 18400400 RESULT

• Hauser W, Bernardy K, Uceyler N, Sommer C. Treatment of fibromyalgia syndrome with gabapentin and pregabalin--a meta-analysis of randomized controlled trials. Pain. 2009 Sep;145(1-2):69-81. doi: 10.1016/j.pain.2009.05.014. Epub 2009 Jun 17.

  PMID: 19539427 RESULT

MeSH Terms

Conditions

Fibromyalgia

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Don Goldenberg, MD

  Newton-Wellesley Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: July 15, 2011
• First Posted: July 19, 2011
• Study Start: September 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: April 14, 2014

Record last verified: 2014-04

Locations

US (1)