Acute GoutPhase 2NCT00997581
Apremilast Therapy for Acute Gouty Arthritis
A Phase 2 study testing apremilast and indomethacin SR in people with Acute Gout, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
The purpose of the study is to learn about a possible new medicine, apremilast, for treating acute gout and compare how it works to indomethacin, a medication that has been used to treat gout for over 50 years. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Acute Gout
- What is being tested?
- apremilast and indomethacin SR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Dec 2010
- Phase
- Phase 2
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must understand and voluntarily sign the informed consent
- Must have the diagnosis of gout proven by identification of urate crystals from body fluids
- Must be male age >18 years at the time of consent
- Must be able to adhere to the study visit schedule and other protocol requirements
- Must meet the following laboratory criteria:
- Hemoglobin > 9.0 g/dL
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- White blood cell (WBC) count > 3000/μL and < 14,000/μL
- Platelet count >100,000/μL
- Serum creatinine < 2.0mg/dL
- Total bilirubin < 2.0 mg/dL
- Aspartate transaminase (AST) and alanine transaminase (ALT) <1.5 X upper limit of normal
- Males, including those who have had a vasectomy, must agree to use barrier contraception (latex condom) when engaging in sexual activity with a female of child-bearing potential (FCBP) while on study medications and for 84 days after taking the last does of the medication
Who cannot join
- Inability to provide voluntary consent
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he were to participate in the study or confounds the ability to interpret the data from the study
- Females
- Systemic fungal infection
- History of recurrent bacterial infection (at least 3 major infections resulting in hospitalization and/or requiring intravenous antibiotic treatment in the past 2 years
- An active infection at presentation
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- Use of any investigational medication within 4 weeks prior to start of study or 5 pharmacokinetic/pharmacodynamic half-lives, whichever is longer
- Any use of corticosteroids, cyclosporine, methotrexate, cyclophosphamide, azathioprine, mycophenolate within 4 weeks prior to start of study
- Any clinically significant abnormality on 12-lead ECG screening
- Malignancy or history of malignancy (except for treated and cured basal-cell skin carcinomas > 3 years prior to screening)
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
The purpose of the study is to learn about a possible new medicine, apremilast, for treating acute gout and compare how it works to indomethacin, a medication that has been used to treat gout for over 50 years.
In order to learn about apremilast, half the participants in this study will receive apremilast and half the participants in this study will receive indomethacin.
Read more
This study will measure the severity and duration of acute gout attacks in research participants, as well as measures of quality of life and any side effects or adverse reactions to the medication.
There will be three study visits: a screening/baseline visit on Day 1, a visit to evaluate response to treatment with study medication at Day 7, and a follow-up visit at Day 21.
Read the detailed description
WITHDRAWN
- Conditions
- Acute Gout
- Being tested
- apremilast, indomethacin SR
- Keywords
- Gout
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apremilastDrug
apremilast 20 mg taken twice daily by mouth
indomethacin SRDrug
indomethacin SR 75 mg taken twice daily by mouth
| Study group | Role | What they receive |
|---|---|---|
| apremilast | Experimental | Experimental treatment for acute gout Receives: Drug: apremilast |
| indomethacin | Active comparator | Medication currently used for the treatment of acute gout Receives: Drug: indomethacin SR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject-reported number of swollen joints, the number of tender joints, the number of warm joints, as well as self-report pain, global assessment, and functional status. Subject-reported time to resolution of symptoms will be measured.
Measured: Day 1, Day 7 and Day 21.
Secondary outcomes (2)
Safety (type, frequency, severity, and relationship of adverse events to apremilast, laboratory, ECG, physical exam or other changes) and tolerability
Measured: Day 1, Day 7 and Day 21.
Quality of Life
Measured: Assessed at Day 1, Day 7 and Day 21 study visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2009 (estimated)
- Study startApr 2010 (estimated)
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Why it stopped: Colaborator withdrew support.
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 Acute GoutStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00997581
- Sponsor's protocol ID
- AP-GOUT-PI-0038
- Status last verified
- Mar 2018
- First submitted
- 9 Oct 2009
- Last updated
- 2 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
van Durme CM, Wechalekar MD, Landewe RB, Pardo Pardo J, Cyril S, van der Heijde D, Buchbinder R. Non-steroidal anti-inflammatory drugs for acute gout. Cochrane Database Syst Rev. 2021 Dec 9;12(12):CD010120. doi: 10.1002/14651858.CD010120.pub3.
PubMed 34882311
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apremilast Therapy for Acute Gouty Arthritis
- ClinicalTrials.gov ID
- NCT00997581
- Acronym / sponsor ID
- AP-GOUT-PI-0038
- Conditions
- Acute Gout
- Keywords
- Gout
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Colaborator withdrew support.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Apr 2010 (estimated)
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 19 Oct 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 purpose of the study is to learn about a possible new medicine, apremilast, for treating acute gout and compare how it works to indomethacin, a medication that has been used to treat gout for over 50 years.
In order to learn about apremilast, half the participants in this study will receive apremilast and half the participants in this study will receive indomethacin.
This study will measure the severity and duration of acute gout attacks in research participants, as well as measures of quality of life and any side effects or adverse reactions to the medication.
There will be three study visits: a screening/baseline visit on Day 1, a visit to evaluate response to treatment with study medication at Day 7, and a follow-up visit at Day 21.
Detailed description
WITHDRAWN
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| apremilast | Experimental | Drug: apremilastExperimental treatment for acute gout |
| indomethacin | Active comparator | Drug: indomethacin SRMedication currently used for the treatment of acute gout |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Must understand and voluntarily sign the informed consent
- Must have the diagnosis of gout proven by identification of urate crystals from body fluids
- Must be male age >18 years at the time of consent
- Must be able to adhere to the study visit schedule and other protocol requirements
- Must meet the following laboratory criteria:
Key exclusion criteria (10 listed)
- Inability to provide voluntary consent
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he were to participate in the study or confounds the ability to interpret the data from the study
- Females
- Systemic fungal infection
- History of recurrent bacterial infection (at least 3 major infections resulting in hospitalization and/or requiring intravenous antibiotic treatment in the past 2 years
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 |
|---|---|---|
| apremilastapremilast 20 mg taken twice daily by mouth | Drug | apremilast |
| indomethacin SRindomethacin SR 75 mg taken twice daily by mouth | Drug | indomethacin |
Primary outcome
Subject-reported number of swollen joints, the number of tender joints, the number of warm joints, as well as self-report pain, global assessment, and functional status. Subject-reported time to resolution of symptoms will be measured.
Time frame: Day 1, Day 7 and Day 21.
2 secondary outcomes
Safety (type, frequency, severity, and relationship of adverse events to apremilast, laboratory, ECG, physical exam or other changes) and tolerability
Time frame: Day 1, Day 7 and Day 21.
Quality of Life
Time frame: Assessed at Day 1, Day 7 and Day 21 study visits
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2018.
- Derived from this study: PubMed 34882311van Durme CM, Wechalekar MD, Landewe RB, Pardo Pardo J, Cyril S, van der Heijde D, Buchbinder R. Non-steroidal anti-inflammatory drugs for acute gout. Cochrane Database Syst Rev. 2021 Dec 9;12(12):CD010120. doi: 10.1002/14651858.CD010120.pub3.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing apremilast and indomethacin SR in people with Acute Gout, run by Dartmouth-Hitchcock Medical Center 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 12 inclusion and 10 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: withdrawn, as of the sponsor's last update on 2 Apr 2018. 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Subject-reported number of swollen joints, the number of tender joints, the number of warm joints, as well as self-report pain, global assessment, and functional status. Subject-reported time to resolution of symptoms will be measured. (time frame: Day 1, Day 7 and Day 21.). 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 NCT00997581, 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 2 Apr 2018.