Rotator Cuff TendonitisPhase 2/3NCT00640939
Diclofenac Patch for Treatment of Mild to Moderate Tendonitis or Bursitis
A Phase 2/3 study testing diclofenac sodium in people with Rotator Cuff Tendonitis and Bicipital Tendonitis, run by Cerimon Pharmaceuticals at 1 site in United States.
Trial summary
The primary purpose of this study is to assess the effectiveness of once daily application of a diclofenac sodium patch to the skin near or over the painful area. In this study, the location being studied will be one of the following: the affected shoulder, elbow, or wrist. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rotator Cuff Tendonitis, Bicipital Tendonitis, Subdeltoid Bursitis of the Shoulder
- What is being tested?
- diclofenac sodium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 308 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Jun 2008
- Phase
- Phase 2/3
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years to 75 years of age
- Onset of painful upper extremity tendonitis or bursitis, no more than 21 days prior to study entry
- Eligible diagnoses are rotator cuff tendonitis, bicipital tendonitis or subdeltoid/subacromial bursitis of the shoulder, medial or lateral epicondylitis of the elbow, and DeQuervain's tenosynovitis of the wrist
- Spontaneous pain with motion or resisted motion and tenderness to palpation over the involved tendon(s), bursa, or epicondyle
- Presence of pain of at least 5, with a maximum of 9, on an 11-point Numerical Rating Scale (NRS)
Who cannot join
- Aspirin, or short half-life NSAID use within 12 hours, or longer half-life NSAID use within 24 hours prior to study entry (see Appendix B: for table of NSAIDs)
- Opioid use within 3 days prior to study entry
- Topical treatment, other than local ice or heat, applied to the painful region within 3 days prior to study entry
- History of peptic ulcer disease within 1 year prior to study entry, any history of gastrointestinal bleeding, or coagulation disorder
- A history of, or evidence for underlying articular disease such as osteoarthritis, rheumatoid arthritis, gout, or pseudogout (calcium pyrophosphate deposition disease)
- Clinically significant and poorly controlled pulmonary, gastrointestinal, hepatic, renal, endocrine, or cardiovascular disease
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- A history of hypersensitivity to diclofenac or diclofenac-containing products
- A history of intolerance to acetaminophen (rescue medication in this trial)
- A history of skin sensitivity to adhesives (e.g. adhesive tape)
- Pregnant or breastfeeding women and women of child-bearing potential not using effective means of contraception
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of a Diclofenac Sodium Patch for the Topical Treatment of Pain Due to Mild to Moderate Tendonitis or Bursitis
The primary purpose of this study is to assess the effectiveness of once daily application of a diclofenac sodium patch to the skin near or over the painful area. In this study, the location being studied will be one of the following: the affected shoulder, elbow, or wrist.
The secondary purpose of this study is to assess the safety and tolerability of the diclofenac patch on the subject's skin, in the location being studied.
Read the detailed description
Cerimon Pharmaceuticals is investigating a topical patch formulation of diclofenac sodium containing 15 mg of diclofenac sodium for the local treatment of acute musculoskeletal pain.
- Conditions
- Rotator Cuff Tendonitis, Bicipital Tendonitis, Subdeltoid Bursitis of the Shoulder, Subacromial Bursitis of the Shoulder, Medial Epicondylitis of the Elbow, Lateral Epicondylitis of the Elbow
- Being tested
- diclofenac sodium, Matching Placebo
- Keywords
- Tendonitis, Bursitis
- Medical subject headings
- Rotator Cuff Injuries, Tendinopathy, Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diclofenac sodiumDrug
Also called diclofenac
15 mg (1%) topical patch; measuring 7 cm by 10 cm; applied once daily
Matching PlaceboDrug
Also called placebo
Matching placebo patch, containing identical constituents to active patch except for diclofenac sodium; measuring 7 cm by 10 cm; applied once daily
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Topical diclofenac sodium patch Receives: Drug: diclofenac sodium |
| B | Placebo comparator | Topical patch identical in appearance to active comparator Receives: Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the efficacy of diclofenac in subjects with tendonitis or bursitis of the shoulder, elbow, or wrist.
Measured: 14 days
Secondary outcomes (1)
Assess the safety and tolerability of diclofenac in subjects with tendonitis or bursitis of the shoulder, elbow, or wrist.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2008 (estimated)
- Study startDec 2007
- Primary completionApr 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TendonitisStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cerimon Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Investigators
- Dan Levitt, MD, Study director, Cerimon Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00640939
- Sponsor's protocol ID
- DCF-003
- Status last verified
- Aug 2008
- First submitted
- 18 Mar 2008
- Last updated
- 6 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of a Diclofenac Sodium Patch for the Topical Treatment of Pain Due to Mild to Moderate Tendonitis or Bursitis
- ClinicalTrials.gov ID
- NCT00640939
- Acronym / sponsor ID
- DCF-003
- Conditions
- Rotator Cuff Tendonitis, Bicipital Tendonitis, Subdeltoid Bursitis of the Shoulder, Subacromial Bursitis of the Shoulder, Medial Epicondylitis of the Elbow, Lateral Epicondylitis of the Elbow
- Keywords
- Tendonitis, Bursitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- Cerimon PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Study start
- Dec 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 21 Mar 2008 (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 primary purpose of this study is to assess the effectiveness of once daily application of a diclofenac sodium patch to the skin near or over the painful area. In this study, the location being studied will be one of the following: the affected shoulder, elbow, or wrist.
The secondary purpose of this study is to assess the safety and tolerability of the diclofenac patch on the subject's skin, in the location being studied.
Detailed description
Cerimon Pharmaceuticals is investigating a topical patch formulation of diclofenac sodium containing 15 mg of diclofenac sodium for the local treatment of acute musculoskeletal pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: diclofenac sodiumTopical diclofenac sodium patch |
| B | Placebo comparator | Drug: Matching PlaceboTopical patch identical in appearance to active comparator |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years to 75 years of age
- Onset of painful upper extremity tendonitis or bursitis, no more than 21 days prior to study entry
- Eligible diagnoses are rotator cuff tendonitis, bicipital tendonitis or subdeltoid/subacromial bursitis of the shoulder, medial or lateral epicondylitis of the elbow, and DeQuervain's tenosynovitis of the wrist
- Spontaneous pain with motion or resisted motion and tenderness to palpation over the involved tendon(s), bursa, or epicondyle
- Presence of pain of at least 5, with a maximum of 9, on an 11-point Numerical Rating Scale (NRS)
Key exclusion criteria (10 listed)
- Aspirin, or short half-life NSAID use within 12 hours, or longer half-life NSAID use within 24 hours prior to study entry (see Appendix B: for table of NSAIDs)
- Opioid use within 3 days prior to study entry
- Topical treatment, other than local ice or heat, applied to the painful region within 3 days prior to study entry
- History of peptic ulcer disease within 1 year prior to study entry, any history of gastrointestinal bleeding, or coagulation disorder
- A history of, or evidence for underlying articular disease such as osteoarthritis, rheumatoid arthritis, gout, or pseudogout (calcium pyrophosphate deposition disease)
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 |
|---|---|---|
| diclofenac sodiumAlso: diclofenac15 mg (1%) topical patch; measuring 7 cm by 10 cm; applied once daily | Drug | A |
| Matching PlaceboAlso: placeboMatching placebo patch, containing identical constituents to active patch except for diclofenac sodium; measuring 7 cm by 10 cm; applied once daily | Drug | B |
Primary outcome
Assess the efficacy of diclofenac in subjects with tendonitis or bursitis of the shoulder, elbow, or wrist.
Time frame: 14 days
1 secondary outcome
Assess the safety and tolerability of diclofenac in subjects with tendonitis or bursitis of the shoulder, elbow, or wrist.
Time frame: 14 days
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 6 Aug 2008.
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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.
Dan Levitt, MD study director
Cerimon Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing diclofenac sodium in people with Rotator Cuff Tendonitis and Bicipital Tendonitis, run by Cerimon Pharmaceuticals 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 5 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: finished, as of the sponsor's last update on 6 Aug 2008. 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 combined 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.
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 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?
Assess the efficacy of diclofenac in subjects with tendonitis or bursitis of the shoulder, elbow, or wrist. (time frame: 14 days). 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 6 Aug 2008.