FibromyalgiaPhase 2NCT00445705

Safety and Efficacy of AGN 203818 for Pain Associated With Fibromyalgia Syndrome

A Phase 2 study testing AGN 203818 in people with Fibromyalgia, run by Allergan at 3 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

This study will explore the safety and effectiveness of different doses of AGN 203818 in treating the pain associated with fibromyalgia syndrome. The study is being conducted in 2 parts. Part A enrolled 211 pts dosed with either 3, 20, 60 mg BID AGN 203818 or placebo over 4 week treatment duration. Read more about this study

Who is it for?: Ages 18 to 75 years, women only
Conditions the study is for: Fibromyalgia
What is being tested?: AGN 203818
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 211 participants
Where: 3 sitesin 3 countries
Study dates: Mar 2007to Jan 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 75 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of fibromyalgia syndrome
Moderate or severe pain associated with fibromyalgia

Who cannot join

Any other uncontrolled disease
Pregnant or nursing females

Trial locations and contacts

3 sites in 3 countries.

Country

City, postcode or hospital

3 sites in 3 countries

United States1 site

Study site
Canton, Ohio

Other trials in United States

Switzerland1 site

Study site
Geneva

Other trials in Switzerland

United Kingdom1 site

Study site
Stanmore

Other trials in United Kingdom

About this study

Conditions: Fibromyalgia
Being tested: placebo, AGN 203818
Medical subject headings: Fibromyalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

placeboDrug
Part A: Placebo every 12 hours for 4 weeks
AGN 203818Drug
Part A: AGN 203818 3 mg every 12 hours for 4 weeks
AGN 203818Drug
Part A: AGN 203818 20 mg every 12 hours for 4 weeks
AGN 203818Drug
Part A: AGN 203818 60 mg every 12 hours for 4 weeks

Study groups in NCT00445705
Study group	Role	What they receive
Placebo	Placebo comparator	Part A: Placebo every 12 hours for 4 weeks Receives: Drug: placebo
AGN 203818 3 mg	Experimental	Part A: 3 mg AGN 203818 every 12 hours for 4 weeks Receives: Drug: AGN 203818
AGN 203818 20 mg	Experimental	Part A: 20 mg AGN 203818 every 12 hours for 4 weeks Receives: Drug: AGN 203818
AGN 203818 60 mg	Experimental	Part A: 60 mg AGN 203818 every 12 hours for 4 weeks Receives: Drug: AGN 203818

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Mean Daily-Average-Pain Score at Week 4
Change from Baseline in mean daily-average-pain score at week 4. Patients recorded their daily average pain on a 11-point scale (where 0 equals no pain and 10 equals worst pain imaginable) using a diary during the 4-week treatment period. A negative number change from baseline represents a decrease in average pain (improvement).
Measured: Baseline, Week 4

Secondary outcomes (3)

Change From Baseline in the Short Form Brief Pain Inventory (SF-BPI) Average Pain Score at Week 4
Change from baseline in the SF-BPI average pain question score at week 4. The SF-BPI is a patient-rated questionnaire that assesses certain aspects of pain including location, intensity, and interference with certain daily activities. The "average pain" question was rated on an 11-point scale (where 0=no pain and 10=worst pain imaginable). A negative number change from baseline indicates a reduction in average pain.
Measured: Baseline, Week 4
Change From Baseline in the Fibromyalgia Impact Questionnaire (FIQ) Total Score of Physical Impairment at Week 4
Change from baseline in FIQ total score of physical impairment at week 4. The FIQ is a disease-specific questionnaire consisting of 10 questions and visual analog scales regarding functional disability, pain intensity, sleep function, stiffness, anxiety, depression, and overall sense of wellbeing. Each question is scored from 0 to 10 with 0 = no impairment (best) and 10 indicates maximum impairment (worst), for a minimum possible score (best) of 0 and a maximum possible (worst) total score of 100. A negative number change from baseline indicates improvement.
Measured: Baseline, Week 4
Patient Global Impression of Change (PGIC) for Fibromyalgia Syndrome Status at Week 4
PGIC status for fibromyalgia syndrome at week 4. The PGIC consists of a self-evaluation by the patient of the overall change of their fibromyalgia syndrome since the beginning of the study, rated on a 7-point scale (score of 1-3 = very much improved to minimally improved; 4= no change; 5-7 = minimally worse to very much worse). Results are presented for the percentage of patients reporting each status: "improved"= score of 1-3; "no change"=score of 4; and "worse"=score of 5-7.
Measured: Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2007Jan 2008

First posted9 Mar 2007 (estimated)
Study startMar 2007
Primary completionJan 2008
Study completionJan 2008

Why it stopped: This study was terminated early due to company decision. Part B was never conducted.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 211 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00445705
Sponsor's protocol ID: 203818-503
Status last verified: Aug 2015
First submitted: 7 Mar 2007
Last updated: 7 Sep 2015
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Fibromyalgia trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of AGN 203818 for Pain Associated With Fibromyalgia Syndrome
ClinicalTrials.gov ID: NCT00445705
Acronym / sponsor ID: 203818-503
Conditions: Fibromyalgia
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: This study was terminated early due to company decision. Part B was never conducted.
Enrolment: 211 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Mar 2007
Primary completion: Jan 2008 (actual)
Study completion: Jan 2008 (actual)
First posted: 9 Mar 2007 (estimated)
Results: Posted 20 Jan 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Placebo	Placebo comparator	Drug: placeboPart A: Placebo every 12 hours for 4 weeks
AGN 203818 3 mg	Experimental	Drug: AGN 203818Part A: 3 mg AGN 203818 every 12 hours for 4 weeks
AGN 203818 20 mg	Experimental	Drug: AGN 203818Part A: 20 mg AGN 203818 every 12 hours for 4 weeks
AGN 203818 60 mg	Experimental	Drug: AGN 203818Part A: 60 mg AGN 203818 every 12 hours for 4 weeks

Who may qualify

Ages: 18 to 75 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Diagnosis of fibromyalgia syndrome
Moderate or severe pain associated with fibromyalgia

Key exclusion criteria (2 listed)

Any other uncontrolled disease
Pregnant or nursing females

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
placeboPart A: Placebo every 12 hours for 4 weeks	Drug	Placebo
AGN 203818Part A: AGN 203818 3 mg every 12 hours for 4 weeks	Drug	AGN 203818 3 mg
AGN 203818Part A: AGN 203818 20 mg every 12 hours for 4 weeks	Drug	AGN 203818 20 mg
AGN 203818Part A: AGN 203818 60 mg every 12 hours for 4 weeks	Drug	AGN 203818 60 mg

Primary outcome

Change From Baseline in Mean Daily-Average-Pain Score at Week 4
Time frame: Baseline, Week 4
Change from Baseline in mean daily-average-pain score at week 4. Patients recorded their daily average pain on a 11-point scale (where 0 equals no pain and 10 equals worst pain imaginable) using a diary during the 4-week treatment period. A negative number change from baseline represents a decrease in average pain (improvement).

3 secondary outcomes

Change From Baseline in the Short Form Brief Pain Inventory (SF-BPI) Average Pain Score at Week 4
Time frame: Baseline, Week 4
Change From Baseline in the Fibromyalgia Impact Questionnaire (FIQ) Total Score of Physical Impairment at Week 4
Time frame: Baseline, Week 4
Patient Global Impression of Change (PGIC) for Fibromyalgia Syndrome Status at Week 4
Time frame: Week 4

Results and safety

Results posted to the registry on 20 Jan 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	53	44
AGN 203818 3 mg	53	42
AGN 203818 20 mg	52	41
AGN 203818 60 mg	53	39

Primary outcome: Change From Baseline in Mean Daily-Average-Pain Score at Week 4

Time frame: Baseline, Week 4. Mean (Standard Deviation). Unit: Scores on a Scale

Measure	Placebo n = 50	AGN 203818 3 mg n = 51	AGN 203818 20 mg n = 50	AGN 203818 60 mg n = 50
Baseline	6.7 (1.04)	6.7 (1.10)	6.6 (0.96)	6.7 (1.14)
Change from Baseline at Week 4	-1.3 (1.66)	-1.2 (1.82)	-1.5 (1.79)	-1.5 (1.85)

Population analysed: Modified Intent-To-Treat (m-ITT). The m-ITT population included all patients who started the study (randomized) and received study medication with at least one post-treatment mean daily-average-pain score.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 52 (0%)	36 of 52 (69.2%)	Not reported
AGN 203818 3 mg	0 of 53 (0%)	37 of 53 (69.8%)	Not reported
AGN 203818 20 mg	1 of 52 (1.9%)	34 of 52 (65.4%)	Not reported
AGN 203818 60 mg	2 of 52 (3.8%)	38 of 52 (73.1%)	Not reported

Limitations and caveats (from the sponsor): This study was terminated early due to company decision. Only Part A results are presented; Part B was never conducted.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Fibromyalgia

Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
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Recruiting
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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.

Medical Director study director

Allergan

3 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AGN 203818 in people with Fibromyalgia, run by Allergan at 3 sites in 3 countries.

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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 7 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States, Switzerland, United Kingdom. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in Mean Daily-Average-Pain Score at Week 4 (time frame: Baseline, Week 4). 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 NCT00445705.

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 7 Sep 2015.