Rotator Cuff Repair of the ShoulderPhase 2NCT00672568
Safety and Tolerability of 4975 in Patients Undergoing Arthroscopic Surgery to Repair the Rotator Cuff of the Shoulder
A Phase 2 study testing 4975 - Highly purified capsaicin in people with Rotator Cuff Repair of the Shoulder, run by Anesiva, Inc. at 4 sites in South Korea.
Trial summary
The purpose of this study is to evaluate the safety, tolerability and explore the efficacy of a single intraoperative injection of 4975 in patients undergoing arthroscopic surgery for rotator cuff repair of the shoulder Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rotator Cuff Repair of the Shoulder
- What is being tested?
- 4975 - Highly purified capsaicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 4 sitesSouth Korea
- Study dates
- Jul 2008to Dec 2008
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female between the ages of 18 and 75 inclusive
- In overall good health and planning to undergo unilateral arthroscopic shoulder surgery to repair at least one rotator cuff tendon involving humeral attachment
- Willing and able to complete the study procedures, pain assessments, and medication diaries, and to communicate in Korean or English with study personnel
Who cannot join
- Shoulder surgery requiring concomitant repair of biceps muscle or associated tendon(s)
- Planning to undergo shoulder surgery on both shoulders
- Use of disallowed pain medications prior to the surgery
- Female patients who are pregnant or lactating or who plan to get pregnant
- Diabetes mellitus with a known HbA1C>9.5
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Kyungpook National university Hospital
Daegu, Jung-gu, 700-721
Gyeongsang National University Hospital
Jinju, Kyungsangnamdo, 660-720
Seoul National University Hospital
Seoul, Kyunggido, 463-707
Kangnam St. Mary's Hospital
Seoul, Seocho-gu, 137-040
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Two-Stage Exploratory Study to Evaluate Safety, Tolerability, Efficacy, and Pharmacokinetics of Intraoperative Subacromial Injection With 4975 in Patients Undergoing Arthroscopic Rotator Cuff Repair of the Shoulder
The purpose of this study is to evaluate the safety, tolerability and explore the efficacy of a single intraoperative injection of 4975 in patients undergoing arthroscopic surgery for rotator cuff repair of the shoulder
Read the detailed description
This is a multicenter, randomized, double-blind, placebo-controlled, two-stage exploratory study in patients undergoing arthroscopic rotator cuff repair surgery.
Stage 1) Patients will be randomized to receive either 4975 or placebo. The dose of 4975 will be escalated in a protocolized manner based on safety and tolerability.
Stage 2) Patients will be randomized in a 1:1 ratio to receive either the selected dose of 4975 or placebo. All patients will be observed in the hospital for at least two days following surgery for safety, tolerability, and efficacy assessments. In addition there will be two planned follow-up visits after hospital discharge.
- Conditions
- Rotator Cuff Repair of the Shoulder
- Being tested
- 4975 - Highly purified capsaicin, Placebo
- Keywords
- Rotator cuff, Shoulder, Arthroscopic shoulder surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4975 - Highly purified capsaicinDrug
Also called Adlea
Solution, 0.5 mg, single dose, injection
4975 - Highly purified capsaicinDrug
Also called Adlea
Solution, 0.75 mg, single dose, injection
4975 - Highly purified capsaicinDrug
Also called Adlea
Solution, 0.1 mg, Single dose, injection
PlaceboDrug
Solution, single dose, injection
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 4975 Receives: Drug: 4975 - Highly purified capsaicin |
| 2 | Experimental | 4975 Receives: Drug: 4975 - Highly purified capsaicin |
| 3 | Experimental | 4975 Receives: Drug: 4975 - Highly purified capsaicin |
| 4 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity using a standard 11-point numerical rating system (NRS), which will be assessed at predefined times following surgery
Measured: 28 Days
Secondary outcomes (1)
Mean overall daily pain and worst daily pain. Pain intensity with physical therapy. Safety outcomes include ECG, vital signs, adverse drug reactions, and wound exams
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2008 (estimated)
- Study startJul 2008
- Primary completionOct 2008
- Study completionDec 2008
Why it stopped: Study has been halted after completing Stage 1, for corporate reasons. No future patients will be enrolled or treated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff Repair of the ShoulderStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anesiva, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Shaun Comfort, MD, Study director, Anesiva, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00672568
- Sponsor's protocol ID
- 114-04P
- Status last verified
- May 2009
- First submitted
- 2 May 2008
- Last updated
- 4 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Two-Stage Exploratory Study to Evaluate Safety, Tolerability, Efficacy, and Pharmacokinetics of Intraoperative Subacromial Injection With 4975 in Patients Undergoing Arthroscopic Rotator Cuff Repair of the Shoulder
- ClinicalTrials.gov ID
- NCT00672568
- Acronym / sponsor ID
- 114-04P
- Conditions
- Rotator Cuff Repair of the Shoulder
- Keywords
- Rotator cuff, Shoulder, Arthroscopic shoulder surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study has been halted after completing Stage 1, for corporate reasons. No future patients will be enrolled or treated.
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Anesiva, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 6 May 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 purpose of this study is to evaluate the safety, tolerability and explore the efficacy of a single intraoperative injection of 4975 in patients undergoing arthroscopic surgery for rotator cuff repair of the shoulder
Detailed description
This is a multicenter, randomized, double-blind, placebo-controlled, two-stage exploratory study in patients undergoing arthroscopic rotator cuff repair surgery.
Stage 1) Patients will be randomized to receive either 4975 or placebo. The dose of 4975 will be escalated in a protocolized manner based on safety and tolerability.
Stage 2) Patients will be randomized in a 1:1 ratio to receive either the selected dose of 4975 or placebo. All patients will be observed in the hospital for at least two days following surgery for safety, tolerability, and efficacy assessments. In addition there will be two planned follow-up visits after hospital discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: 4975 - Highly purified capsaicin4975 |
| 2 | Experimental | Drug: 4975 - Highly purified capsaicin4975 |
| 3 | Experimental | Drug: 4975 - Highly purified capsaicin4975 |
| 4 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female between the ages of 18 and 75 inclusive
- In overall good health and planning to undergo unilateral arthroscopic shoulder surgery to repair at least one rotator cuff tendon involving humeral attachment
- Willing and able to complete the study procedures, pain assessments, and medication diaries, and to communicate in Korean or English with study personnel
Key exclusion criteria (5 listed)
- Shoulder surgery requiring concomitant repair of biceps muscle or associated tendon(s)
- Planning to undergo shoulder surgery on both shoulders
- Use of disallowed pain medications prior to the surgery
- Female patients who are pregnant or lactating or who plan to get pregnant
- Diabetes mellitus with a known HbA1C>9.5
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 |
|---|---|---|
| 4975 - Highly purified capsaicinAlso: AdleaSolution, 0.5 mg, single dose, injection | Drug | 1 |
| 4975 - Highly purified capsaicinAlso: AdleaSolution, 0.75 mg, single dose, injection | Drug | 2 |
| 4975 - Highly purified capsaicinAlso: AdleaSolution, 0.1 mg, Single dose, injection | Drug | 3 |
| PlaceboSolution, single dose, injection | Drug | 4 |
Primary outcome
Pain intensity using a standard 11-point numerical rating system (NRS), which will be assessed at predefined times following surgery
Time frame: 28 Days
1 secondary outcome
Mean overall daily pain and worst daily pain. Pain intensity with physical therapy. Safety outcomes include ECG, vital signs, adverse drug reactions, and wound exams
Time frame: 28 Days
Results and safety
The study was stopped early (reason given: Study has been halted after completing Stage 1, for corporate reasons. No future patients will be enrolled or treated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2009.
- Anesiva Home PageLink provided by the sponsor.
- ADLEA Product InformationLink provided by the sponsor.
Related trials for Rotator Cuff Repair of the Shoulder
Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
Active, not recruitingPhase 2
Influence of an Anti-osteoporotic Drug on Healing After Surgical Repair of Chronic Rotator Cuff Lesions of the Shoulder
Orthopedics, Traumatology
Active, not recruiting
BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
Rotator Cuff Tears
Recruiting
Arthroscopic Rotator Cuff Repair With Long Head of Biceps Transposition and Acellular Dermal Matrix Augmentation for Large to Massive Incompletely Repairable Rotator Cuff Tears
Rotator Cuff Tears, Rotator Cuff Injuries
Active, not recruiting
Fibrin Clot Augmentation in Arthroscopic Rotator Cuff Repair
Rotator Cuff Tears, Rotator Cuff Injuries
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.
Shaun Comfort, MD study director
Anesiva, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 4975 - Highly purified capsaicin in people with Rotator Cuff Repair of the Shoulder, run by Anesiva, Inc. at 4 sites in South Korea.
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 5 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 4 May 2009. 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 South Korea. 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 was stopped early (reason given: Study has been halted after completing Stage 1, for corporate reasons. No future patients will be enrolled or treated.). 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?
Pain intensity using a standard 11-point numerical rating system (NRS), which will be assessed at predefined times following surgery (time frame: 28 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 4 May 2009.