search
Back to results

Fibromyalgia of Less Than One Year Duration. Study of Pregabalin

Primary Purpose

Fibromyalgia

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Pregabalin
Sponsored by
Newton-Wellesley Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, pregabalin, Lyrica

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • • 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

Exclusion Criteria:

  • • 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.

Sites / Locations

  • Newton-Wellesley Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pregabalin

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change in pain VAS from study entry to end of study

Secondary Outcome Measures

Change in total score FIQ from study entry to last visit.
Change in total score FM 2010 Clinical Scale from study entry to last visit.
Change in PGIC from study entry to last visit.
Change in total score for HRQOL from study entry to last visit.

Full Information

First Posted
July 15, 2011
Last Updated
April 11, 2014
Sponsor
Newton-Wellesley Hospital
Collaborators
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT01397006
Brief Title
Fibromyalgia of Less Than One Year Duration. Study of Pregabalin
Official Title
Fibromyalgia of Less Than One Year Duration in Primary Care: Treatment Response in a Double Blind, Placebo Controlled Study of Pregabalin
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Withdrawn
Study Start Date
September 2011 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Newton-Wellesley Hospital
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The randomized clinical trial of pregabalin in early-onset fibromyalgia. At the baseline visit, each subject will be asked if they wish to consider enrolling in Part II. If they agree, the details of the study will be explained and Dr Goldenberg will consent those who wish to enroll in Part II. The first 75 patients who consent will be enrolled in the study, the randomized clinical trial of pregabalin in early-onset fibromyalgia. After a study subject has been enrolled, they will be randomized to one of two treatment groups. All subjects will be randomized, 1:1 either to the pregabalin group (group A) or the placebo group (group B). Randomization will take place after enrollment via selection of one of a multitude of envelopes containing a random number. Each random number will have been preassigned to either Group A or group B.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia, pregabalin, Lyrica

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pregabalin
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Other Intervention Name(s)
Lyrica
Intervention Description
Pregabalin dose escalating every 2 weeks. Starting dose is 75 mg. Titrated up to maximum of 450mg
Primary Outcome Measure Information:
Title
Change in pain VAS from study entry to end of study
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in total score FIQ from study entry to last visit.
Time Frame
12 weeks
Title
Change in total score FM 2010 Clinical Scale from study entry to last visit.
Time Frame
12 Weeks
Title
Change in PGIC from study entry to last visit.
Time Frame
12 weeks
Title
Change in total score for HRQOL from study entry to last visit.
Time Frame
12 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • 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 Exclusion Criteria: • 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Don Goldenberg, MD
Organizational Affiliation
Newton-Wellesley Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Newton-Wellesley Hospital
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02462
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
10219923
Citation
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.
Results Reference
background
PubMed Identifier
12849719
Citation
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.
Results Reference
background
PubMed Identifier
2306288
Citation
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.
Results Reference
background
PubMed Identifier
18537456
Citation
Goldenberg DL. Introduction: fibromyalgia and its related disorders. J Clin Psychiatry. 2008;69 Suppl 2:4-5. No abstract available.
Results Reference
background
PubMed Identifier
17602996
Citation
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.
Results Reference
background
PubMed Identifier
3553636
Citation
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.
Results Reference
result
PubMed Identifier
20461783
Citation
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.
Results Reference
result
PubMed Identifier
15818684
Citation
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.
Results Reference
result
PubMed Identifier
18278830
Citation
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.
Results Reference
result
PubMed Identifier
18400400
Citation
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.
Results Reference
result
PubMed Identifier
19539427
Citation
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.
Results Reference
result

Learn more about this trial

Fibromyalgia of Less Than One Year Duration. Study of Pregabalin

We'll reach out to this number within 24 hrs