FibromyalgiaPhase 4FlexdoseNCT01226667
Fixed Versus Flexible Dosing of Pregabalin in Patients With Fibromyalgia
A Phase 4 study testing Pregabalin in people with Fibromyalgia, run by Osteoporosis Medical Center, Beverly Hills, CA at 5 sites in United States.
Trial summary
A 9-week randomized double-blind, multi-center study of 172 patients, who after 1 week baseline evaluation are randomized to either fixed dose pregabalin starting at 75 mg BID for one week and increased to 150 mg BID for 7 weeks or flexibly dosed pregabalin given BID (75-300 mg/d) increased gradually over 4 weeks then… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Pregabalin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 5 sitesUnited States
- Study dates
- Jul 2010to Jul 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of fibromyalgia by ACR criteria
- ambulatory patients
- complete of 5 pain diaries during 1 week evaluation
- other inclusion criteria may apply
Who cannot join
- pregnant or of childbearing potential not using contraceptives
- use of pregabalin in the past
- concomitant use of opioids or gabapentin
- estimated creatinine clearance less than 60
- other criteria may apply
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
David Silver MD Inc
Beverly Hills, California, 90211
Stuart L Silverman MD Inc.
Beverly Hills, California, 90211
Talbert Medical Group
Huntington Beach, California, 92646
Catalina Pointe Clinial Research
Tucson, California, 85704
Affilaites in Medical Specialty
West Hills, California, 91307
About this study
A 9-week randomized double-blind, multi-center study of 172 patients, who after 1 week baseline evaluation are randomized to either fixed dose pregabalin starting at 75 mg BID for one week and increased to 150 mg BID for 7 weeks or flexibly dosed pregabalin given BID (75-300 mg/d) increased gradually over 4 weeks then maintained at that same dosing for 4 weeks.It is proposed that use of flexible dosing combined with nightly dosing would have similar pain relief to fixed dosing, would improve adherence, would have less side effects and would be more likely to improve sleep.
- Conditions
- Fibromyalgia
- Being tested
- Pregabalin
- Keywords
- fibromyalgia, lyrica, pregabalin
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Fixed dosing of pregabalin: Week 1: 75 mg bid. Weeks 2 - 8: 150 mg bid. Week 9 (Days 57-60 and Days 61-63): 75 mg bid.
Flexible dosing of pregabalin: Week 1: placebo in the AM and 75 mg nightly; Week 2: placebo in the AM and 150 mg nightly.; Week 3 placebo in the a.m., 225 mg nightly; Weeks 4 - 8 placebo in the a.m., 300 mg nightly. Week 9 (Days 57-60) placebo in the a.m,, 150 mg bid nightly and Days 61-63: placebo in the a.m., and 75 mg bid nightly.
| Study group | Role | What they receive |
|---|---|---|
| Flexible Dose | Active comparator | flexibly dosed pregabalin given BID (75-300 mg/d) increased gradually over 4 weeks then maintained at that same dosing for 4 weeks Receives: Drug: Pregabalin |
| Fixed Dosing | Active comparator | 75 mg BID for one week and increased to 150 mg BID for 7 weeks Receives: Drug: Pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score evaluation by NRS
Least square mean change in Fibromyalgia pain at 8weeks compared to baseline utilizing an 11 point numerical rating scale daily pain diary (0 = no pain to 10 =worst possible pain) performed at daily awakening.
Measured: 8 weeks
Secondary outcomes (3)
Patient Global Impression of Change
Measured: At weeks 4 and 8
Discontinuation rate
Discontinuation rates due to lack of efficacy and discontinuation rates due to adverse event.
Measured: 9 weeks
Improvements in Wolfe Symptom Severity Score
Wolfe Symptom Severity scales for pain, fatigue, trouble sleeping, trouble with anxiety or depression, trouble thinking or remembering, overall FM severity, problems awaking feeling unrefreshed
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osteoporosis Medical Center, Beverly Hills, CA
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Keaton Nasser, Study director, Osteoporosis Medical CenterStuart L Silverman, M.D., Principal investigator, Osteoporosis Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01226667
- Sponsor's protocol ID
- SLS2009001
- Acronym
- Flexdose
- Status last verified
- Jul 2012
- First submitted
- 1 Oct 2010
- Last updated
- 31 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Nasser K, Kivitz AJ, Maricic MJ, Silver DS, Silverman SL. Twice daily versus once nightly dosing of pregabalin for fibromyalgia: a double-blind randomized clinical trial of efficacy and safety. Arthritis Care Res (Hoboken). 2014 Feb;66(2):293-300. doi: 10.1002/acr.22111.
PubMed 23983064
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fixed Versus Flexible Dosing of Pregabalin in Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT01226667
- Acronym / sponsor ID
- Flexdose / SLS2009001
- Conditions
- Fibromyalgia
- Keywords
- fibromyalgia, lyrica, pregabalin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Osteoporosis Medical Center, Beverly Hills, CAUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jul 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 22 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A 9-week randomized double-blind, multi-center study of 172 patients, who after 1 week baseline evaluation are randomized to either fixed dose pregabalin starting at 75 mg BID for one week and increased to 150 mg BID for 7 weeks or flexibly dosed pregabalin given BID (75-300 mg/d) increased gradually over 4 weeks then maintained at that same dosing for 4 weeks.It is proposed that use of flexible dosing combined with nightly dosing would have similar pain relief to fixed dosing, would improve adherence, would have less side effects and would be more likely to improve sleep.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flexible Dose | Active comparator | Drug: Pregabalinflexibly dosed pregabalin given BID (75-300 mg/d) increased gradually over 4 weeks then maintained at that same dosing for 4 weeks |
| Fixed Dosing | Active comparator | Drug: Pregabalin75 mg BID for one week and increased to 150 mg BID for 7 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of fibromyalgia by ACR criteria
- ambulatory patients
- complete of 5 pain diaries during 1 week evaluation
- other inclusion criteria may apply
Key exclusion criteria (5 listed)
- pregnant or of childbearing potential not using contraceptives
- use of pregabalin in the past
- concomitant use of opioids or gabapentin
- estimated creatinine clearance less than 60
- other criteria may apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PregabalinFixed dosing of pregabalin: Week 1: 75 mg bid. Weeks 2 - 8: 150 mg bid. Week 9 (Days 57-60 and Days 61-63): 75 mg bid. Flexible dosing of pregabalin: Week 1: placebo in the AM and 75 mg nightly; Week 2: placebo in the AM and 150 mg nightly.; Week 3 placebo in the a.m., 225 mg nightly; Weeks 4 - 8 placebo in the a.m., 300 mg nightly. Week 9 (Days 57-60) placebo in the a.m,, 150 mg bid nightly and Days 61-63: placebo in the a.m., and 75 mg bid nightly. | Drug | Fixed Dosing, Flexible Dose |
Primary outcome
Pain score evaluation by NRS
Time frame: 8 weeks
Least square mean change in Fibromyalgia pain at 8weeks compared to baseline utilizing an 11 point numerical rating scale daily pain diary (0 = no pain to 10 =worst possible pain) performed at daily awakening.
3 secondary outcomes
Patient Global Impression of Change
Time frame: At weeks 4 and 8
Discontinuation rate
Time frame: 9 weeks
Improvements in Wolfe Symptom Severity Score
Time frame: 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2012.
- Derived from this study: PubMed 23983064Nasser K, Kivitz AJ, Maricic MJ, Silver DS, Silverman SL. Twice daily versus once nightly dosing of pregabalin for fibromyalgia: a double-blind randomized clinical trial of efficacy and safety. Arthritis Care Res (Hoboken). 2014 Feb;66(2):293-300. doi: 10.1002/acr.22111.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keaton Nasser study director
Osteoporosis Medical Center
Stuart L Silverman, M.D. principal investigator
Osteoporosis Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pregabalin in people with Fibromyalgia, run by Osteoporosis Medical Center, Beverly Hills, CA at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score evaluation by NRS (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01226667, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2012.