FibromyalgiaPhase 3KetoforFMSNCT01553318
Novel Use of (Oral) Ketotifen for the Treatment of Fibromyalgia: A Pilot Study
A Phase 3 study testing Ketotifen in people with Fibromyalgia, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this 10-week study is to determine the effects of a medication called Ketotifen on pain sensitivity; and fibromyalgia-related pain. Ketotifen works by inhibiting (to prevent or slow down) certain substances in the body that are known to cause inflammation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Ketotifen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Dec 2012
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to qualify the subject:
- must have been diagnosed with fibromyalgia by a medical doctor
- must be between the ages of 18 to 65 years of age
- must have a weekly overall body pain average score ≥ 4
- must pass a screening questionnaire that calculates a physical impairment of ≥ 10
- must be on stable doses of his/her current medication for at least past four weeks
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- must limit any changes in his/her medication(s) (e.g., dose change, addition or discontinuation of any medication that effects the central nervous system, e.g., benzodiazepines, sedative/hypnotic, etc. ) during the 10-week study period unless medically necessary
- must report all medication including herbal supplements and over-the-counter medications, e.g. cold medication, eye drops, etc. that he/she is currently taking to a member of the research team
- must be willing to maintain a medication diary provided to him/her during the 10-week study period
- must be willing to abstain (not take) any fibromyalgia related medication including over-the-counter for at least 8-hours prior to each of the two testing visits (Otherwise, he/she may take these medication(s) immediately after pain sensitivity testing has been completed and as prescribed in-between visits)
- must agree to use a proven method of contraception to prevent pregnancy throughout this study
Who cannot join
- The subject will not be allowed to participate if:
- he/she has a history of seizures
- he/she has atopic dermatitis (also called eczema) or chronic urticaria (hives)
- he/she has chronic thrombocytopenia (a low blood platelet count)
- she is currently pregnant, are planning to become pregnant, or is breastfeeding
- he/she has been diagnosed by a psychiatrist with Schizophrenia or bipolar disorder
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- he/she has been diagnosed with another major rheumatic conditions (i.e. rheumatoid arthritis, systemic lupus erythematosus, scleroderma and/or other connective tissue diseases)
- he/she plans to undergo an elective surgery within the study timeline
- he/she is in the process of filing, or plan to file for disability benefits within the study timeline
- his/her screening labs results are abnormal (i.e., elevated SGPT and low platelet count)
- he/she is currently using any anti-allergy drugs (ophthalmic or oral histamine antagonist), leukotriene inhibitors (e.g., montelukast) or prednisone
Trial locations and contacts
1 site in 1 country.
United States1 site
IU Clincial Research Center for Pain and Fibromyalgia
Indianapolis, Indiana, 46202
About this study
Official title: Novel Use of Ketotifen (Mast Cell Stabilizer) in Fibromyalgia: A Pilot Study
The purpose of this 10-week study is to determine the effects of a medication called Ketotifen on pain sensitivity; and fibromyalgia-related pain.
Ketotifen works by inhibiting (to prevent or slow down) certain substances in the body that are known to cause inflammation. It is an antihistamine that reduces the harmful effects of histamine. The ophthalmic (eye drops) formulation of ketotifen has been approved by the Food and Drug Administration (FDA) and has been available in the United States for more than a decade. Oral (taken by mouth) ketotifen has been in available in other countries for several decades. Commonly prescribed for the maintenance treatment of asthma and allergic rhinitis, ketotifen has long track record of safety. To date, the oral form of ketotifen has not been approved by the FDA, therefore this study is referred to as an "investigational drug study." Prior to opening recruitment an "investigational new drug" (IND) application which included scientific data and information regarding human safety plans was submitted to and approved by the FDA.
Read the detailed description
Approximately 46 subjects will be participating in this research. Each subject will be randomized (like flipping a coin) to one of two groups; approximately 23 volunteers will be randomized to receive the active medication and 23 will receive the placebo. Both groups will be "blinded" (will not know) to which group they have been assigned.
The study will be conducted at the Indiana University Clinical Research Center for Pain (CRCP), located on the IUPUI campus in the National Institute of Fitness and Sport building,at 250 University Blvd.,Suite 118 Indianapolis, Indiana, 46202.
To summarize: The subject will be asked to visit the CRCP on four separate occasions: Initial Screening, Week 1, Week 2, and Week 10. This study also includes, answering questionnaires, taking study medication, maintaining a written medication diary and agreeing to remain in weekly contact with the study team to answer a short side effect questionnaire. The side effect questionnaire will be conducted from week 1-4 and then once every 2 weeks from week 4-10.
Study Overview:
Week 0 (clinic visit 1):
- Informed consent and initial screening questionnaire,
- Review of all current medications
- Light physical assessment, e.g. blood pressure, height, weight
- The investigators will obtain a urine sample for a urine pregnancy test (UPT)
- Complete short thumb pressure testing in order to set the testing parameters for futures tests (week 1 and week 10)
- Receive 'pain score' wrist monitor with instructions to record his/her pain level three times each day for one week
- Receive a one-week medication packet along with instructions to take one tablet twice a day for seven days along with entering dosing information in a medication diary.
Week 1 (clinic visit 2):
- Submit his/her pain score wrist monitor
- Submit his/her medication diary for review and return any unused medication
- Complete the self-assessment questionnaires via computer
- Undergo a thumb pressures pain sensitivity test
- If qualified to continue, the subject will receive the next 7-day supply of either a placebo or the active medication, ketotifen 1 mg. along with verbal and written instructions and a medication diary.
Week 2 (visit 3):
- The investigators will assess the subject's willingness to continue study participation.
- Review medication diary and medication side-effect/benefit checklist along with any unused study medication. If the subject has not experienced any bothersome side effect and agree to continue,he/she will be issued the next level of either the placebo or the active medication Ketotifen (2 mg.).
- To assure the subjects' safety, the project coordinator or a member of the research team will complete a medication side-effect questionnaire. The subject will be asked to schedule a weekly check-in call for week 3 and 4 and once every 2 weeks from week 4 to week 10 (weeks 6, 8, and 10)
Week 10 (visit 4):
- One week prior to this visit, the subject will receive a 'pain score' wrist monitor via an express delivery service (e.g., FedEx) and will be asked to enter his/her pain level three times a day for one week. Then return it during this visit.
- Review medication side effect/benefit checklist, medication diary and return any unused medication.
- Completion of self-assessment questionnaires via computer
- Undergo a thumb pressures pain sensitivity test.
- Conditions
- Fibromyalgia
- Being tested
- Ketotifen, Placebo (Sugar Pill)
- Keywords
- Fibromyalgia, FMS
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetotifenDrug
Also called Zaditor
After meeting the full eligibility requirement, participants will be randomized. From week 1 to 2, subjects will receive either ketotifen 1 mg by mouth, twice a day or the equivalent placebo. Thereafter, subjects will take ketotifen to 2 mg by mouth twice a day or the equivalent placebo.
Placebo (Sugar Pill)Drug
Also called Placebo, Sugar Pill
After meeting the full eligibility requirement, participants will be randomized. From week 1 to 2, subjects will receive either ketotifen 1 mg BID or the equivalent placebo. Thereafter, subjects will take ketotifen to 2 mg BID or the equivalent placebo.
| Study group | Role | What they receive |
|---|---|---|
| Active Ketotifen | Active comparator | After meeting the full eligibility requirement, participants will be randomized. Approximately 26 of the 51 participants will assigned to this arm of the study. Receives: Drug: Ketotifen |
| Placebo for Ketotifen | Placebo comparator | After meeting the full eligibility requirement, participants will be randomized. Approximately 25 of the 51 participants will assigned to this arm of the study. Subjects in this arm will receive the placebo drug. Receives: Drug: Placebo (Sugar Pill) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Weekly Average Pain Score on the Visual Analog Scale at Week 10
Change in weekly average pain score from baseline to week 10 (range from -10 to +10): interpretation= the more negative the value is, the larger reduction in pain severity at week 10 is
Measured: baseline and week 10
Secondary outcomes (3)
Change From Baseline in Evoked Pain Score at Week 10
Change in evoked pain score from baseline to week 10 (scale range -20 to +20): interpretation= the more negative the value is, the larger the reduction in sensitivity to pressure pain stimuli
Measured: baseline and week 10
Fibromyalgia Impact Questionnaire
Change in global symptom severity [scale range from -100 to +100] = the more negative the value is, the greater the improvement in overall symptom severity
Measured: baseline and week 10
Change From Baseline in the Blood Levels of IL-8, MCP-1 and Eotaxin at Week 10
Change in peripheral blood levels of IL-8, MCP-1 and Eotaxin from baseline to week 10
Measured: baseline and week10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2012
- Study completionDec 2012
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.
- More trials run by Indiana UniversityThe 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 3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dennis C. Ang, MD, Principal investigator, Wake Forest University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01553318
- Sponsor's protocol ID
- 1106005839 (1106-01)
- Acronym
- KetoforFMS
- Status last verified
- Sep 2016
- First submitted
- 1 Mar 2012
- Last updated
- 17 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Use of Ketotifen (Mast Cell Stabilizer) in Fibromyalgia: A Pilot Study
- ClinicalTrials.gov ID
- NCT01553318
- Acronym / sponsor ID
- KetoforFMS / 1106005839 (1106-01)
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, FMS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 14 Mar 2012 (estimated)
- Results
- Posted 17 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this 10-week study is to determine the effects of a medication called Ketotifen on pain sensitivity; and fibromyalgia-related pain.
Ketotifen works by inhibiting (to prevent or slow down) certain substances in the body that are known to cause inflammation. It is an antihistamine that reduces the harmful effects of histamine. The ophthalmic (eye drops) formulation of ketotifen has been approved by the Food and Drug Administration (FDA) and has been available in the United States for more than a decade. Oral (taken by mouth) ketotifen has been in available in other countries for several decades. Commonly prescribed for the maintenance treatment of asthma and allergic rhinitis, ketotifen has long track record of safety. To date, the oral form of ketotifen has not been approved by the FDA, therefore this study is referred to as an "investigational drug study." Prior to opening recruitment an "investigational new drug" (IND) application which included scientific data and information regarding human safety plans was submitted to and approved by the FDA.
Detailed description
Approximately 46 subjects will be participating in this research. Each subject will be randomized (like flipping a coin) to one of two groups; approximately 23 volunteers will be randomized to receive the active medication and 23 will receive the placebo. Both groups will be "blinded" (will not know) to which group they have been assigned.
The study will be conducted at the Indiana University Clinical Research Center for Pain (CRCP), located on the IUPUI campus in the National Institute of Fitness and Sport building,at 250 University Blvd.,Suite 118 Indianapolis, Indiana, 46202.
To summarize: The subject will be asked to visit the CRCP on four separate occasions: Initial Screening, Week 1, Week 2, and Week 10. This study also includes, answering questionnaires, taking study medication, maintaining a written medication diary and agreeing to remain in weekly contact with the study team to answer a short side effect questionnaire. The side effect questionnaire will be conducted from week 1-4 and then once every 2 weeks from week 4-10.
Study Overview:
Week 0 (clinic visit 1):
- Informed consent and initial screening questionnaire,
- Review of all current medications
- Light physical assessment, e.g. blood pressure, height, weight
- The investigators will obtain a urine sample for a urine pregnancy test (UPT)
- Complete short thumb pressure testing in order to set the testing parameters for futures tests (week 1 and week 10)
- Receive 'pain score' wrist monitor with instructions to record his/her pain level three times each day for one week
- Receive a one-week medication packet along with instructions to take one tablet twice a day for seven days along with entering dosing information in a medication diary.
Week 1 (clinic visit 2):
- Submit his/her pain score wrist monitor
- Submit his/her medication diary for review and return any unused medication
- Complete the self-assessment questionnaires via computer
- Undergo a thumb pressures pain sensitivity test
- If qualified to continue, the subject will receive the next 7-day supply of either a placebo or the active medication, ketotifen 1 mg. along with verbal and written instructions and a medication diary.
Week 2 (visit 3):
- The investigators will assess the subject's willingness to continue study participation.
- Review medication diary and medication side-effect/benefit checklist along with any unused study medication. If the subject has not experienced any bothersome side effect and agree to continue,he/she will be issued the next level of either the placebo or the active medication Ketotifen (2 mg.).
- To assure the subjects' safety, the project coordinator or a member of the research team will complete a medication side-effect questionnaire. The subject will be asked to schedule a weekly check-in call for week 3 and 4 and once every 2 weeks from week 4 to week 10 (weeks 6, 8, and 10)
Week 10 (visit 4):
- One week prior to this visit, the subject will receive a 'pain score' wrist monitor via an express delivery service (e.g., FedEx) and will be asked to enter his/her pain level three times a day for one week. Then return it during this visit.
- Review medication side effect/benefit checklist, medication diary and return any unused medication.
- Completion of self-assessment questionnaires via computer
- Undergo a thumb pressures pain sensitivity test.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Ketotifen | Active comparator | Drug: KetotifenAfter meeting the full eligibility requirement, participants will be randomized. Approximately 26 of the 51 participants will assigned to this arm of the study. |
| Placebo for Ketotifen | Placebo comparator | Drug: Placebo (Sugar Pill)After meeting the full eligibility requirement, participants will be randomized. Approximately 25 of the 51 participants will assigned to this arm of the study. Subjects in this arm will receive the placebo drug. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- must have been diagnosed with fibromyalgia by a medical doctor
- must be between the ages of 18 to 65 years of age
- must have a weekly overall body pain average score ≥ 4
- must pass a screening questionnaire that calculates a physical impairment of ≥ 10
- must be on stable doses of his/her current medication for at least past four weeks
Key exclusion criteria (11 listed)
- he/she has a history of seizures
- he/she has atopic dermatitis (also called eczema) or chronic urticaria (hives)
- he/she has chronic thrombocytopenia (a low blood platelet count)
- she is currently pregnant, are planning to become pregnant, or is breastfeeding
- he/she has been diagnosed by a psychiatrist with Schizophrenia or bipolar disorder
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 |
|---|---|---|
| KetotifenAlso: ZaditorAfter meeting the full eligibility requirement, participants will be randomized. From week 1 to 2, subjects will receive either ketotifen 1 mg by mouth, twice a day or the equivalent placebo. Thereafter, subjects will take ketotifen to 2 mg by mouth twice a day or the equivalent placebo. | Drug | Active Ketotifen |
| Placebo (Sugar Pill)Also: Placebo, Sugar PillAfter meeting the full eligibility requirement, participants will be randomized. From week 1 to 2, subjects will receive either ketotifen 1 mg BID or the equivalent placebo. Thereafter, subjects will take ketotifen to 2 mg BID or the equivalent placebo. | Drug | Placebo for Ketotifen |
Primary outcome
Change From Baseline in Weekly Average Pain Score on the Visual Analog Scale at Week 10
Time frame: baseline and week 10
Change in weekly average pain score from baseline to week 10 (range from -10 to +10): interpretation= the more negative the value is, the larger reduction in pain severity at week 10 is
3 secondary outcomes
Change From Baseline in Evoked Pain Score at Week 10
Time frame: baseline and week 10
Fibromyalgia Impact Questionnaire
Time frame: baseline and week 10
Change From Baseline in the Blood Levels of IL-8, MCP-1 and Eotaxin at Week 10
Time frame: baseline and week10
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Dennis C. Ang, MD principal investigator
Wake Forest University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ketotifen in people with Fibromyalgia, run by Indiana University at 1 site 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 11 inclusion and 11 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 17 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 17 Nov 2016). 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 Weekly Average Pain Score on the Visual Analog Scale at Week 10 (time frame: baseline and week 10). 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 17 Nov 2016; AzTrials last refreshed its copy on 8 Nov 2026.