Polymyalgia RheumaticaPhase 3NCT01821040
A Study Assessing the Efficacy and Safety of Lodotra® Compared to Prednisone IR in Subjects Suffering From PMR
A Phase 3 study testing Lodotra® and Prednisone IR (immediate release) in people with Polymyalgia Rheumatica, run by Mundipharma Research Limited at 1 site in United Kingdom.
Trial summary
The study compares the efficacy and safety of modified release prednisone versus immediate release prednisone in patients suffering from polymyalgia rheumatica. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Polymyalgia Rheumatica
- What is being tested?
- Lodotra® and Prednisone IR (immediate release)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2013to Apr 2014
- Phase
- Phase 3
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females, 50 years of age or older who provided written informed consent.
- Females less than one year post-menopausal must have a negative serum or urine pregnancy test recorded prior to the first dose of study medication, be non-lactating, and willing to use adequate and highly effective methods of contraception throughout the study. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilisation, implants, injectables, combined oral contraceptives, some IUDs (Intrauterine Device, hormonal), sexual abstinence or vasectomised partner).
- Subjects newly diagnosed with polymyalgia rheumatica and previously untreated with glucocorticoids for PMR. The diagnosis of polymyalgia rheumatica must be confirmed by all of the following criteria:
- New onset bilateral shoulder pain or new onset bilateral shoulder and hip girdle pain.
- PMR VAS score over the last 24 hours before the Screening Visit ≥ 50 (on a 0 - 100 scale).
- Morning stiffness duration of ≥ 45 min on the day before the Screening Visit.
- Acute phase response shown by elevated C-reactive protein (CRP; ≥ 2 times ULN).
- Subjects willing and able to participate in all aspects of the study and comply with the use of study medication.
Who cannot join
- Females who are pregnant (positive β-hCG test) or lactating.
- Subjects with any contraindication/history of hypersensitivity to predniso(lo)ne or other ingredients.
- Significant renal impairment (serume creatinine > 150 µmol/L).
- Significant hepatic impairment (ALT, AST and GGT > 2.5 ULN).
- Subjects suffering from another disease which requires glucocorticosteroid treatment. Topical glucocorticosteroids, e.g. intra-nasal or inhaled glucocorticosteroids are allowed but should be kept at a stable dose throughout the study.
- Continued use of systemic glucocorticoids within 4 weeks prior to the Screening Visit.
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- Joint injections with glucocorticoids within 6 weeks prior to the Screening Visit.
- Subjects who require treatment with non-permitted concomitant therapies.
- Evidence of clinically significant cardiovascular, renal, hepatic, gastrointestinal or psychiatric disease at the time of screening, as determined by medical history, clinical laboratory tests, ECG results, and physical examination, that would place the subject at risk upon exposure to the study medication or that may confound the analysis and/or interpretation of the study results.
- Active alcohol or drug abuse.
- Subjects suffering from giant cell arteritis, late onset rheumatoid arthritis or other inflammatory rheumatoid diseases.
- Subjects suffering from drug-induced myalgia.
- Subjects suffering from fibromyalgia
- Subjects suffering from systemic lupus erythemathosus.
- Subjects suffering from neurological conditions, e.g. Parkinson's disease.
- Subjects suffering from active cancer.
- Subjects suffering from an active infection.
- Subjects who participated in a clinical research study involving a new chemical entity or an experimental drug within 30 days prior to the Screening Visit.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Southend University Hospital
Westcliff-on-Sea, SS9 9RY
About this study
Official title: A Randomised, Multi-centre, Double-blind, Active-controlled, Parallel Group Study to Assess the Efficacy and Safety of Modified Release Prednisone (Lodotra®) Compared to Immediate Release Prednisone (Prednisone IR) in Subjects Suffering From Polymyalgia Rheumatica (PMR).
The study compares the efficacy and safety of modified release prednisone versus immediate release prednisone in patients suffering from polymyalgia rheumatica.
Read the detailed description
The study consists of a screening phase, followed by a 4 week double-blind phase. During the double-blind phase, the patients will be randomised in a 1:1 ratio to either Lodotra® or immediate release prednisone (prednisone IR) plus respective placebo.
After completion of the double-blind phase, patients will be re-randomised in a 1:1 ratio to open-label Lodotra® or prednisone IR for 48 weeks. During the open-label phase, the dose of study medication will be tapered based on titration criteria.
- Conditions
- Polymyalgia Rheumatica
- Being tested
- Lodotra®, Prednisone IR (immediate release)
- Keywords
- Polymyalgia rheumatica, PMR, Modified release prednisone
- Medical subject headings
- Polymyalgia Rheumatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lodotra®Drug
Also called Modified release prednisone
Lodotra, starting dose of 15mg administered in the evening
Prednisone IR (immediate release)Drug
Prednisone IR 15mg daily start dose (immediate release) administered in the morning,
| Study group | Role | What they receive |
|---|---|---|
| Lodotra® | Experimental | Lodotra, starting dose of 15mg administered in the evening Receives: Drug: Lodotra® |
| Prednisone IR | Active comparator | Prednisone IR 15mg daily start dose (immediate release) administered in the morning Receives: Drug: Prednisone IR (immediate release) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To show that treatment with Lodotra® is noninferior to treatment with prednisone IR with regards to the percentage of complete responders.
Measured: 4 weeks
Secondary outcomes (1)
Patient reported outcomes
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 posted29 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polymyalgia RheumaticaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mundipharma Research Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01821040
- Sponsor's protocol ID
- LOD3501
- Other IDs
- 2011-002353-57
- Status last verified
- Oct 2018
- First submitted
- 14 Mar 2013
- Last updated
- 24 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Multi-centre, Double-blind, Active-controlled, Parallel Group Study to Assess the Efficacy and Safety of Modified Release Prednisone (Lodotra®) Compared to Immediate Release Prednisone (Prednisone IR) in Subjects Suffering From Polymyalgia Rheumatica (PMR).
- ClinicalTrials.gov ID
- NCT01821040
- Acronym / sponsor ID
- LOD3501
- Conditions
- Polymyalgia Rheumatica
- Keywords
- Polymyalgia rheumatica, PMR, Modified release prednisone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Mundipharma Research LimitedIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 29 Mar 2013 (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 compares the efficacy and safety of modified release prednisone versus immediate release prednisone in patients suffering from polymyalgia rheumatica.
Detailed description
The study consists of a screening phase, followed by a 4 week double-blind phase. During the double-blind phase, the patients will be randomised in a 1:1 ratio to either Lodotra® or immediate release prednisone (prednisone IR) plus respective placebo.
After completion of the double-blind phase, patients will be re-randomised in a 1:1 ratio to open-label Lodotra® or prednisone IR for 48 weeks. During the open-label phase, the dose of study medication will be tapered based on titration criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lodotra® | Experimental | Drug: Lodotra®Lodotra, starting dose of 15mg administered in the evening |
| Prednisone IR | Active comparator | Drug: Prednisone IR (immediate release)Prednisone IR 15mg daily start dose (immediate release) administered in the morning |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males or females, 50 years of age or older who provided written informed consent.
- Females less than one year post-menopausal must have a negative serum or urine pregnancy test recorded prior to the first dose of study medication, be non-lactating, and willing to use adequate and highly effective methods of contraception throughout the study. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilisation, implants, injectables, combined oral contraceptives, some IUDs (Intrauterine Device, hormonal), sexual abstinence or vasectomised partner).
- Subjects newly diagnosed with polymyalgia rheumatica and previously untreated with glucocorticoids for PMR. The diagnosis of polymyalgia rheumatica must be confirmed by all of the following criteria:
- Subjects willing and able to participate in all aspects of the study and comply with the use of study medication.
Key exclusion criteria (18 listed)
- Females who are pregnant (positive β-hCG test) or lactating.
- Subjects with any contraindication/history of hypersensitivity to predniso(lo)ne or other ingredients.
- Significant renal impairment (serume creatinine > 150 µmol/L).
- Significant hepatic impairment (ALT, AST and GGT > 2.5 ULN).
- Subjects suffering from another disease which requires glucocorticosteroid treatment. Topical glucocorticosteroids, e.g. intra-nasal or inhaled glucocorticosteroids are allowed but should be kept at a stable dose throughout the study.
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 |
|---|---|---|
| Lodotra®Also: Modified release prednisoneLodotra, starting dose of 15mg administered in the evening | Drug | Lodotra® |
| Prednisone IR (immediate release)Prednisone IR 15mg daily start dose (immediate release) administered in the morning, | Drug | Prednisone IR |
Primary outcome
To show that treatment with Lodotra® is noninferior to treatment with prednisone IR with regards to the percentage of complete responders.
Time frame: 4 weeks
1 secondary outcome
Patient reported outcomes
Time frame: 4 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2018.
- Link to ResultsLink 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.
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 3 study testing Lodotra® and Prednisone IR (immediate release) in people with Polymyalgia Rheumatica, run by Mundipharma Research Limited at 1 site in United Kingdom.
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 8 inclusion and 18 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 24 Oct 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 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. 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?
The study was stopped early. Results are not available in the source record.
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?
To show that treatment with Lodotra® is noninferior to treatment with prednisone IR with regards to the percentage of complete responders. (time frame: 4 weeks). 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 24 Oct 2018.