Rotator Cuff TearPhase 1NCT00936559
Study Evaluating Safety Of BMP-655/ACS As An Adjuvant Therapy For Rotator Cuff Repair
A Phase 1 study of Rotator Cuff Tear, run by Pfizer at 4 sites in 2 countries.
Trial summary
Study to assess the safety of 3 differing concentrations of BMP-655/ACS in subjects with full thickness Rotator Cuff Tears (RCTs). 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
- 13 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Sep 2010to Feb 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
- Male subjects and surgically sterile or postmenopausal female subjects between the ages of 25 and 75 years old with specific full-thickness RCTs identified on closed MRI within 3 months before surgery.
Who cannot join
- Subjects who have had previous surgical intervention to the shoulder joint under study or additional injury requiring surgical repair or a history of shoulder dislocation in the affected shoulder or physical examination findings of instability in either shoulder
- Subjects who are unable to complete functional evaluations because of any other concurrent injuries or impairment in either the arm
- Subjects identified with specific fatty infiltration of their RC muscles on MRI taken within 3 months prior to surgical repair
- Subjects with moderate or severe degenerative arthritis of the shoulder under study or any bone abnormalities as confirmed on a radiograph
- Subjects with rheumatologic conditions affecting the shoulder joints or autoimmune disorders, treated with more than 3 corticosteroid injections in the shoulder under study within 1 year of planned surgery, any recent corticosteroid injection in the shoulder or currently receiving oral corticosteroids
- Subjects who are either unwilling or unable to undergo examination with closed MRI.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Germany2 sites
Pfizer Investigational Site
Berlin, 10117
Pfizer Investigational Site
Hamburg, 20246
Netherlands2 sites
Pfizer Investigational Site
Amsterdam
Pfizer Investigational Site
Hoofddorp, 2134 TM
About this study
Official title: Randomized, Single-Blind, 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 Procedure
Study to assess the safety of 3 differing concentrations of BMP-655/ACS in subjects with full thickness Rotator Cuff Tears (RCTs).
Read the detailed description
This decision to terminate enrollment in this study is based on the company's change in prioritization for the portfolio and was not due to any safety concerns, or regulatory interactions.
Patients already enrolled in the study, should continue to complete assessments as described in the protocol.
- Conditions
- Rotator Cuff Tear
- Being tested
- BMP-655/ACS or Standard of Care
- Keywords
- rotator cuff tear repair, open surgical technique, safety
- 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 or Standard of CareBiological
Decision was made by Legal to withhold this information
BMP-655/ACS or Standard of CareBiological
Decision was made by Legal to withhold this information.
BMP-655/ACS or Standard of CareBiological
Decision was made by Legal to withhold this information,
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Arm A Receives: Biological: BMP-655/ACS or Standard of Care |
| 2 | Experimental | Arm B Receives: Biological: BMP-655/ACS or Standard of Care |
| 3 | Experimental | Arm C Receives: Biological: BMP-655/ACS or Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abnormal X-rays, MRIs, CT scans, physical examination of limb, functional evaluations, AE/SAE, vital signs, subject assessment of pain, lab tests
Measured: 1 year
Secondary outcomes (1)
Investigator Questionnaire
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2009 (estimated)
- Study startSep 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Why it stopped: See termination reason in detailed description.
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 13 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
- NCT00936559
- Sponsor's protocol ID
- 3202V1-1001
- Status last verified
- Apr 2012
- First submitted
- 2 Jul 2009
- Last updated
- 13 Apr 2012
- 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 13 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Single-Blind, 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 Procedure
- ClinicalTrials.gov ID
- NCT00936559
- Acronym / sponsor ID
- 3202V1-1001
- Conditions
- Rotator Cuff Tear
- Keywords
- rotator cuff tear repair, open surgical technique, safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See termination reason in detailed description.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 10 Jul 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.
Study to assess the safety of 3 differing concentrations of BMP-655/ACS in subjects with full thickness Rotator Cuff Tears (RCTs).
Detailed description
This decision to terminate enrollment in this study is based on the company's change in prioritization for the portfolio and was not due to any safety concerns, or regulatory interactions.
Patients already enrolled in the study, should continue to complete assessments as described in the protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: BMP-655/ACS or Standard of CareArm A |
| 2 | Experimental | Biological: BMP-655/ACS or Standard of CareArm B |
| 3 | Experimental | Biological: BMP-655/ACS or Standard of CareArm C |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male subjects and surgically sterile or postmenopausal female subjects between the ages of 25 and 75 years old with specific full-thickness RCTs identified on closed MRI within 3 months before surgery.
Key exclusion criteria (6 listed)
- Subjects who have had previous surgical intervention to the shoulder joint under study or additional injury requiring surgical repair or a history of shoulder dislocation in the affected shoulder or physical examination findings of instability in either shoulder
- Subjects who are unable to complete functional evaluations because of any other concurrent injuries or impairment in either the arm
- Subjects identified with specific fatty infiltration of their RC muscles on MRI taken within 3 months prior to surgical repair
- Subjects with moderate or severe degenerative arthritis of the shoulder under study or any bone abnormalities as confirmed on a radiograph
- Subjects with rheumatologic conditions affecting the shoulder joints or autoimmune disorders, treated with more than 3 corticosteroid injections in the shoulder under study within 1 year of planned surgery, any recent corticosteroid injection in the shoulder or currently receiving oral corticosteroids
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 or Standard of CareDecision was made by Legal to withhold this information | Biological | 1 |
| BMP-655/ACS or Standard of CareDecision was made by Legal to withhold this information. | Biological | 2 |
| BMP-655/ACS or Standard of CareDecision was made by Legal to withhold this information, | Biological | 3 |
Primary outcome
Abnormal X-rays, MRIs, CT scans, physical examination of limb, functional evaluations, AE/SAE, vital signs, subject assessment of pain, lab tests
Time frame: 1 year
1 secondary outcome
Investigator Questionnaire
Time frame: 1 year
Results and safety
The study was stopped early (reason given: See termination reason in detailed description.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2012.
- 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.
- To obtain contact information for a study center near you, click here.Link 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.
Pfizer CT.gov Call Center study director
Pfizer
4 sites in 2 countries: 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 4 sites in 2 countries.
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 6 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 13 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Netherlands. 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 (reason given: See termination reason in detailed description.). 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?
Abnormal X-rays, MRIs, CT scans, physical examination of limb, functional evaluations, AE/SAE, vital signs, subject assessment of pain, lab tests (time frame: 1 year). 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 NCT00936559, 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 13 Apr 2012.