BursitisPhase 2NCT01205477
Safety and Efficacy of Methylprednisolone Infiltration in Anserine Bursitis Treatment
A Phase 2 study testing EXPERIMENTAL in people with Bursitis, run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.
Trial summary
To investigate the safety and efficacy of methylprednisolone infiltration in anserine bursitis treatment Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Bursitis
- What is being tested?
- EXPERIMENTAL
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteMexico
- Study dates
- Sep 2009to Jul 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of anserine bursitis
Who cannot join
- Intraarticular pathology that reflects pain in the medial part of the knee
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Universitario "José Eleuterio González"
Monterrey, Nuevo León, 66024
About this study
Official title: Phase 2 Double-blinded, Placebo-controlled, Clinical Trial for Safety and Efficacy of Methylprednisolone Infiltration in Anserine Bursitis Treatment
To investigate the safety and efficacy of methylprednisolone infiltration in anserine bursitis treatment
- Conditions
- Bursitis
- Being tested
- EXPERIMENTAL, PLACEBO
- Keywords
- Anserine bursitis
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXPERIMENTALDrug
Also called DEPOMEDROL
Infiltration of 40 mg of methylprednisolone acetate plus 1 mL of xylocaine and Diclofenac sodium 100 mg PO QD for 10 days
PLACEBODrug
Infiltration of 1 mL of xylocaine and Diclofenac sodium 100 mg PO QD for 10 days
| Study group | Role | What they receive |
|---|---|---|
| Methylprednisolone | Experimental | Infiltration of 40 mg of methylprednisolone acetate plus 1 mL of xylocaine Receives: Drug: EXPERIMENTAL |
| Placebo | Placebo comparator | Infiltration of 1 mL of xylocaine Receives: Drug: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC score
The WOMAC (Westren Ontario and McMaster Universities) index is used to assess patients with osteoarthritis of the hip or knee using 24 parameters. It can be used to monitor the course of the disease or to determine the effectiveness of anti-rheumatic medications.
Pain, Stiffness and Physical functionVisual analogue scale (VAS) may be used ranging from 0 to 10.
Measured: 4 weeks
Secondary outcomes (3)
VAS satisfaction
Visual Analoge Scale for satisfaction
Measured: 4 weeks
Improvement
Percentage of improvement
Measured: 4 weeks
SAFETY
Pain at infiltration site, ecchymosis, bleeding, paresthesias, skin infection, anaphilaxy, vasovagal reaction
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 posted20 Sep 2010 (estimated)
- Study startSep 2009
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BursitisStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Nuevo Leon
- Sponsor type
- University, hospital or other
- Investigators
- Mario Alberto Garza Elizondo, MD, Study director, Universidad Autónoma de Nuevo León
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01205477
- Sponsor's protocol ID
- RE09-009
- Status last verified
- Jun 2009
- First submitted
- 28 Jul 2010
- Last updated
- 20 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Alvarez-Nemegyei J, Canoso JJ. Evidence-Based Soft Tissue Rheumatology IV: Anserine Bursitis. J Clin Rheumatol. 2004 Aug;10(4):205-6. doi: 10.1097/01.rhu.0000135561.41660.b0.
PubMed 17043509Calvo-Alén J, Rua-Figueroa I, Erausquin C. Anserine bursitis treatment: local corticoesteroid injction against NSAID: a prospective study [Spanish]. Rev Esp Reumatol. 1993;20:13-15.
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Double-blinded, Placebo-controlled, Clinical Trial for Safety and Efficacy of Methylprednisolone Infiltration in Anserine Bursitis Treatment
- ClinicalTrials.gov ID
- NCT01205477
- Acronym / sponsor ID
- RE09-009
- Conditions
- Bursitis
- Keywords
- Anserine bursitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Universidad Autonoma de Nuevo LeonUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 20 Sep 2010 (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.
To investigate the safety and efficacy of methylprednisolone infiltration in anserine bursitis treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylprednisolone | Experimental | Drug: EXPERIMENTALInfiltration of 40 mg of methylprednisolone acetate plus 1 mL of xylocaine |
| Placebo | Placebo comparator | Drug: PLACEBOInfiltration of 1 mL of xylocaine |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of anserine bursitis
Key exclusion criteria (1 listed)
- Intraarticular pathology that reflects pain in the medial part of the knee
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 |
|---|---|---|
| EXPERIMENTALAlso: DEPOMEDROLInfiltration of 40 mg of methylprednisolone acetate plus 1 mL of xylocaine and Diclofenac sodium 100 mg PO QD for 10 days | Drug | Methylprednisolone |
| PLACEBOInfiltration of 1 mL of xylocaine and Diclofenac sodium 100 mg PO QD for 10 days | Drug | Placebo |
Primary outcome
WOMAC score
Time frame: 4 weeks
The WOMAC (Westren Ontario and McMaster Universities) index is used to assess patients with osteoarthritis of the hip or knee using 24 parameters. It can be used to monitor the course of the disease or to determine the effectiveness of anti-rheumatic medications. Pain, Stiffness and Physical functionVisual analogue scale (VAS) may be used ranging from 0 to 10.
3 secondary outcomes
VAS satisfaction
Time frame: 4 weeks
Improvement
Time frame: 4 weeks
SAFETY
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 20 Sep 2010.
- Background: PubMed 17043509Alvarez-Nemegyei J, Canoso JJ. Evidence-Based Soft Tissue Rheumatology IV: Anserine Bursitis. J Clin Rheumatol. 2004 Aug;10(4):205-6. doi: 10.1097/01.rhu.0000135561.41660.b0.
- BackgroundCalvo-Alén J, Rua-Figueroa I, Erausquin C. Anserine bursitis treatment: local corticoesteroid injction against NSAID: a prospective study [Spanish]. Rev Esp Reumatol. 1993;20:13-15.
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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.
Mario Alberto Garza Elizondo, MD study director
Universidad Autónoma de Nuevo León
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 EXPERIMENTAL in people with Bursitis, run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.
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 20 Sep 2010. 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 Mexico. 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?
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?
WOMAC score (time frame: 4 weeks). 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 NCT01205477, which also lists 2 linked publications.
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 20 Sep 2010.