FibromyalgiaNCT00819624
A Study to Compare Two Ways of Completing Pain and Sleep Questions and to Evaluate a New Daily Questionaire for Assessing Fatigue in Fibromyalgia Patients
A study testing Interactive Voice Response System (IVRS) and Personal Digital Assisstant (PDA) in people with Fibromyalgia, run by Pfizer at 15 sites in United States.
Trial summary
The study has two goals. The first goal of the study is to compare two methods of administering questions about pain and sleep interference. The two methods being compared are a telephone based system and an electronic hand held diary. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Interactive Voice Response System (IVRS) and Personal Digital Assisstant (PDA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 15 sitesUnited States
- Study dates
- Jan 2009to Mar 2009
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fibromyalgia using ACR diagnosis
Who cannot join
- Other confounding disease including other inflammatory disease, pain and depression
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Pfizer Investigational Site
Baton Rouge, Louisiana, 70809
Pfizer Investigational Site
Charlottesville, Virginia, 22911
Pfizer Investigational Site
Cincinnati, Ohio, 45219
Pfizer Investigational Site
Jefferson City, Missouri, 65109
Pfizer Investigational Site
Johnson City, New York, 13790
Pfizer Investigational Site
Johnson City, Tennessee, 37601
Pfizer Investigational Site
Lake Jackson, Texas, 77566
Pfizer Investigational Site
New Tazewell, Tennessee, 37825
Pfizer Investigational Site
North Dartmouth, Massachusetts, 02747
Pfizer Investigational Site
Omaha, Nebraska, 68114
Pfizer Investigational Site
Richmond, Virginia, 23294
Pfizer Investigational Site
Roseville, California, 95661
Pfizer Investigational Site
Spokane, Washington, 99216
Pfizer Investigational Site
St Louis, Missouri, 63141
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103
About this study
Official title: A Non-Drug Methodology Study To Explore The Psychometric Properties Of A Daily Diary Of Fatigue Symptoms And To Compare Two Modes Of Administration Of Pain And Sleep Interference Questions For Use With Fibromyalgia Patients
The study has two goals. The first goal of the study is to compare two methods of administering questions about pain and sleep interference. The two methods being compared are a telephone based system and an electronic hand held diary. The second goal of the study is to evaluate a daily diary to evaluate fatigue symptoms in patients with fibromyalgia.
- Conditions
- Fibromyalgia
- Being tested
- Interactive Voice Response System (IVRS), Personal Digital Assisstant (PDA)
- Keywords
- fibromyalgia methodology pain sleep fatigue
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive Voice Response System (IVRS)Other
Telephone based system
Personal Digital Assisstant (PDA)Other
Electronic Hand Held diary
| Study group | Role | What they receive |
|---|---|---|
| Interactive Voice Response System | Other | Not described Receives: Other: Interactive Voice Response System (IVRS) |
| Personal Digital Assisstant | Other | Not described Receives: Other: Personal Digital Assisstant (PDA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily questions about pain asked using a telephone based system and a hand held diary
Measured: 4 weeks
Daily questions about sleep asked using a telephone based system and a hand held diary
Measured: 4 weeks
Daily questions about fatigue asked hand held electronic diary
Measured: 2 weeks
Questionaires about pain, fatigue, function, quality of life, patients impression of change and diary ease of use
Measured: 4 weeks
Secondary outcomes (1)
Questionaires about sleep, mood and fibromyalgia severity
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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 N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00819624
- Sponsor's protocol ID
- A9001393
- Status last verified
- Feb 2010
- First submitted
- 7 Jan 2009
- Last updated
- 15 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Drug Methodology Study To Explore The Psychometric Properties Of A Daily Diary Of Fatigue Symptoms And To Compare Two Modes Of Administration Of Pain And Sleep Interference Questions For Use With Fibromyalgia Patients
- ClinicalTrials.gov ID
- NCT00819624
- Acronym / sponsor ID
- A9001393
- Conditions
- Fibromyalgia
- Keywords
- fibromyalgia methodology pain sleep fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 9 Jan 2009 (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.
The study has two goals. The first goal of the study is to compare two methods of administering questions about pain and sleep interference. The two methods being compared are a telephone based system and an electronic hand held diary. The second goal of the study is to evaluate a daily diary to evaluate fatigue symptoms in patients with fibromyalgia.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interactive Voice Response System | Other | Other: Interactive Voice Response System (IVRS) |
| Personal Digital Assisstant | Other | Other: Personal Digital Assisstant (PDA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Fibromyalgia using ACR diagnosis
Key exclusion criteria (1 listed)
- Other confounding disease including other inflammatory disease, pain and depression
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 |
|---|---|---|
| Interactive Voice Response System (IVRS)Telephone based system | Other | Interactive Voice Response System |
| Personal Digital Assisstant (PDA)Electronic Hand Held diary | Other | Personal Digital Assisstant |
Primary outcome
Daily questions about pain asked using a telephone based system and a hand held diary
Time frame: 4 weeks
Daily questions about sleep asked using a telephone based system and a hand held diary
Time frame: 4 weeks
Daily questions about fatigue asked hand held electronic diary
Time frame: 2 weeks
Questionaires about pain, fatigue, function, quality of life, patients impression of change and diary ease of use
Time frame: 4 weeks
1 secondary outcome
Questionaires about sleep, mood and fibromyalgia severity
Time frame: 4 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 15 Feb 2010.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive Voice Response System (IVRS) and Personal Digital Assisstant (PDA) in people with Fibromyalgia, run by Pfizer at 15 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 1 inclusion and 1 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 15 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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.
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?
Daily questions about pain asked using a telephone based system and a hand held diary (time frame: 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2010.