Rotator Cuff TearPhase 1NCT01122498
A Safety Study Of BMP-655/ACS As An Adjuvant Therapy For Treatment Of Rotator Cuff Tears
A Phase 1 study of Rotator Cuff Tear, run by Pfizer at 9 sites in Japan.
Trial summary
Subjects undergoing an open surgical repair for their torn Rotator Cuff (RC) will be consented, screened, and enrolled in the study if they meet all eligibility criteria. At the time of open surgical repair, subjects who are randomized to receive the test article in addition to the Standard of Care (SOC) will be… Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Rotator Cuff Tear
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 9 sitesJapan
- Study dates
- Jun 2010to Apr 2012
- Phase
- Phase 1
- 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Japanese male subjects and surgically sterile or postmenopausal Japanese female subjects between the ages of 25 and 75 years.
- without tears of the subscapularis or labral pathology requiring surgical repair, as estimated on closed magnetic resonance imaging (MRI) within 3 months before surgery.
- In the shoulder under study, subjects should be able to achieve a passive range of motion (ROM), which is at least 150 degrees in forward elevation (flexion), abduction, and elevation in the scapular plane (scapular abduction). Subjects should have at least 40 degrees of passive ROM in external rotation. In the contralateral shoulder, subjects should be able to achieve active ROM, which is at least 150 degrees in forward elevation (flexion), abduction, and elevation in the scapular plane (scapular abduction). Subjects should have at least 40 degrees of active ROM in external rotation.
Who cannot join
- Subjects who have had previous surgical intervention to the shoulder joint under study (eg, shoulder arthroscopy, acromioplasty, previous RCR, fracture). Subjects with stage 3 or 4 fatty infiltration (according to the Goutallier grading scale) of their RC muscles on MRI taken within 3 months prior to surgical repair or subjects with moderate or severe degenerative glenohumeral arthritis (according to the Samilson and Prieto arthrosis grading scale ), avascular necrosis, calcific tendonitis, chondrocalcinosis, hypertrophic osteoarthropathy, or Paget disease of the shoulder under study or any bone abnormalities (eg, HO, previous fracture) as confirmed on a radiograph within 3 months prior to surgical repair.
- Subjects with rheumatologic conditions (eg, rheumatoid arthritis, ankylosing spondylitis) affecting the shoulder joints, or autoimmune disorders. Subjects treated with more than 3 corticosteroid injections in the shoulder under study within 1 year prior to planned surgery or subjects treated with any corticosteroid injection in the shoulder under study within 3 months prior to planned surgery or subjects currently receiving oral corticosteroids or taking them within the past 3 months.
- Subjects who are either unwilling or unable (eg, because of claustrophobia or the presence of an automatic cardioverter defibrillator) to undergo examination with closed MRI. Subjects with any other major illness/condition that will substantially increase the risk associated with the subject's participation in and completion of the study.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Japan9 sites
Pfizer Investigational Site
Chikushino-shi, Fukuoka
Pfizer Investigational Site
Hiroshima
Pfizer Investigational Site
Kanagawa
Pfizer Investigational Site
Koushi, Kumamoto
Pfizer Investigational Site
Kumamoto, Kumamoto
Pfizer Investigational Site
Kumamoto
Pfizer Investigational Site
Kure, Hiroshima
Pfizer Investigational Site
Nagano
Pfizer Investigational Site
Toyonaka, Osaka
About this study
Official title: A Phase 1, Randomized, Open-Label, Standard Of Care Control, Dose-Escalating, Multicenter, Safety Study Of BMP-655/ACS As An Adjuvant Therapy For Treatment Of Full-Thickness Rotator Cuff Tears Treated By Means Of An Open Surgical Repair
Subjects undergoing an open surgical repair for their torn Rotator Cuff (RC) will be consented, screened, and enrolled in the study if they meet all eligibility criteria. At the time of open surgical repair, subjects who are randomized to receive the test article in addition to the Standard of Care (SOC) will be hospitalized and have a single dose of BMP-655/ACS surgically implanted at the site of tendon attachment to bone. Subjects who are randomized to receive SOC alone will receive no test article. Following surgery, subjects will be prescribed a rehabilitation plan. Subjects will then complete 9 follow-up visits beginning 24 hours after surgery and continuing through 52 weeks.
- Conditions
- Rotator Cuff Tear
- Being tested
- BMP-655/ACS+Standard of care or Standard of care
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMP-655/ACS+Standard of care or Standard of careBiological
BMP-655/ACS 0.015mg/mL
BMP-655/ACS+Standard of care or Standard of careBiological
BMP-655/ACS 0.05mg/mL
BMP-655/ACS+Standard of care or Standard of careBiological
BMP-655/ACS 0.15mg/mL or 0.025mg/mL
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Biological: BMP-655/ACS+Standard of care or Standard of care |
| 2 | Experimental | Not described Receives: Biological: BMP-655/ACS+Standard of care or Standard of care |
| 3 | Experimental | Not described Receives: Biological: BMP-655/ACS+Standard of care or Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the safety and tolerability of 3 concentrations of BMP-655/ACS in Japanese subjects with full-thickness RCTs treated by means of an open surgical repair.
Measured: 12, 26 and 52 weeks
Secondary outcomes (1)
Assess the feasibility of implanting BMP-655/ACS through an open surgical procedure in Japanese subjects and detect circulating levels of BMP-655 in the blood of Japanese subjects.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2010 (estimated)
- Study startJun 2010
- Primary completionApr 2012
- Study completionApr 2012
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 Rotator Cuff TearStudies of the same condition, open and under way.
- More trials run by PfizerThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01122498
- Sponsor's protocol ID
- 3202V1-1003
- Other IDs
- B1861003
- Status last verified
- Feb 2013
- First submitted
- 3 May 2010
- Last updated
- 22 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Ide J, Mochizuki Y, van Noort A, Ochi H, Sridharan S, Itoi E, Greiner S. Local rhBMP-12 on an Absorbable Collagen Sponge as an Adjuvant Therapy for Rotator Cuff Repair-A Phase 1, Randomized, Standard of Care Control, Multicenter Study: Part 2-A Pilot Study of Functional Recovery and Structural Outcomes. Orthop J Sports Med. 2017 Sep 12;5(9):2325967117726740. doi: 10.1177/2325967117726740. eCollection 2017 Sep.
PubMed 28932752
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open-Label, Standard Of Care Control, Dose-Escalating, Multicenter, Safety Study Of BMP-655/ACS As An Adjuvant Therapy For Treatment Of Full-Thickness Rotator Cuff Tears Treated By Means Of An Open Surgical Repair
- ClinicalTrials.gov ID
- NCT01122498
- Acronym / sponsor ID
- 3202V1-1003
- Conditions
- Rotator Cuff Tear
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 23 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 13 May 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.
Subjects undergoing an open surgical repair for their torn Rotator Cuff (RC) will be consented, screened, and enrolled in the study if they meet all eligibility criteria. At the time of open surgical repair, subjects who are randomized to receive the test article in addition to the Standard of Care (SOC) will be hospitalized and have a single dose of BMP-655/ACS surgically implanted at the site of tendon attachment to bone. Subjects who are randomized to receive SOC alone will receive no test article. Following surgery, subjects will be prescribed a rehabilitation plan. Subjects will then complete 9 follow-up visits beginning 24 hours after surgery and continuing through 52 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: BMP-655/ACS+Standard of care or Standard of care |
| 2 | Experimental | Biological: BMP-655/ACS+Standard of care or Standard of care |
| 3 | Experimental | Biological: BMP-655/ACS+Standard of care or Standard of care |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Japanese male subjects and surgically sterile or postmenopausal Japanese female subjects between the ages of 25 and 75 years.
- without tears of the subscapularis or labral pathology requiring surgical repair, as estimated on closed magnetic resonance imaging (MRI) within 3 months before surgery.
- In the shoulder under study, subjects should be able to achieve a passive range of motion (ROM), which is at least 150 degrees in forward elevation (flexion), abduction, and elevation in the scapular plane (scapular abduction). Subjects should have at least 40 degrees of passive ROM in external rotation. In the contralateral shoulder, subjects should be able to achieve active ROM, which is at least 150 degrees in forward elevation (flexion), abduction, and elevation in the scapular plane (scapular abduction). Subjects should have at least 40 degrees of active ROM in external rotation.
Key exclusion criteria (3 listed)
- Subjects who have had previous surgical intervention to the shoulder joint under study (eg, shoulder arthroscopy, acromioplasty, previous RCR, fracture). Subjects with stage 3 or 4 fatty infiltration (according to the Goutallier grading scale) of their RC muscles on MRI taken within 3 months prior to surgical repair or subjects with moderate or severe degenerative glenohumeral arthritis (according to the Samilson and Prieto arthrosis grading scale ), avascular necrosis, calcific tendonitis, chondrocalcinosis, hypertrophic osteoarthropathy, or Paget disease of the shoulder under study or any bone abnormalities (eg, HO, previous fracture) as confirmed on a radiograph within 3 months prior to surgical repair.
- Subjects with rheumatologic conditions (eg, rheumatoid arthritis, ankylosing spondylitis) affecting the shoulder joints, or autoimmune disorders. Subjects treated with more than 3 corticosteroid injections in the shoulder under study within 1 year prior to planned surgery or subjects treated with any corticosteroid injection in the shoulder under study within 3 months prior to planned surgery or subjects currently receiving oral corticosteroids or taking them within the past 3 months.
- Subjects who are either unwilling or unable (eg, because of claustrophobia or the presence of an automatic cardioverter defibrillator) to undergo examination with closed MRI. Subjects with any other major illness/condition that will substantially increase the risk associated with the subject's participation in and completion of 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 |
|---|---|---|
| BMP-655/ACS+Standard of care or Standard of careBMP-655/ACS 0.015mg/mL | Biological | 1 |
| BMP-655/ACS+Standard of care or Standard of careBMP-655/ACS 0.05mg/mL | Biological | 2 |
| BMP-655/ACS+Standard of care or Standard of careBMP-655/ACS 0.15mg/mL or 0.025mg/mL | Biological | 3 |
Primary outcome
Assess the safety and tolerability of 3 concentrations of BMP-655/ACS in Japanese subjects with full-thickness RCTs treated by means of an open surgical repair.
Time frame: 12, 26 and 52 weeks
1 secondary outcome
Assess the feasibility of implanting BMP-655/ACS through an open surgical procedure in Japanese subjects and detect circulating levels of BMP-655 in the blood of Japanese subjects.
Time frame: 52 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 22 Feb 2013.
- Derived from this study: PubMed 28932752Ide J, Mochizuki Y, van Noort A, Ochi H, Sridharan S, Itoi E, Greiner S. Local rhBMP-12 on an Absorbable Collagen Sponge as an Adjuvant Therapy for Rotator Cuff Repair-A Phase 1, Randomized, Standard of Care Control, Multicenter Study: Part 2-A Pilot Study of Functional Recovery and Structural Outcomes. Orthop J Sports Med. 2017 Sep 12;5(9):2325967117726740. doi: 10.1177/2325967117726740. eCollection 2017 Sep.
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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.
Pfizer CT.gov Call Center study director
Pfizer
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Rotator Cuff Tear, run by Pfizer at 9 sites in Japan.
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 3 inclusion and 3 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 22 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Japan. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Assess the safety and tolerability of 3 concentrations of BMP-655/ACS in Japanese subjects with full-thickness RCTs treated by means of an open surgical repair. (time frame: 12, 26 and 52 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 NCT01122498, 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 22 Feb 2013.