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Dupuytren's ContracturePhase 3CORD-INCT00528606

AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Dupuytren's Contracture

A Phase 3 study testing collagenase clostridium histolyticum in people with Dupuytren's Contracture, run by Endo USA Inc., a Keenova Therapeutics Company at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This was a Phase 3, double-blind, randomized, placebo-controlled study conducted in the United States. Subjects with a diagnosis of Dupuytren's contracture in a metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint that resulted in a fixed flexion deformity of at least one finger, other than the thumb, that… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dupuytren's Contracture
What is being tested?
collagenase clostridium histolyticum
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
308 participants
Where
15 sitesUnited States
Study dates
Aug 2007to Apr 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects with a diagnosis of Dupuytren's contracture, with a fixed flexion deformity of at least one finger, other than the thumb, that had a contracture at least 20°, but not greater than 100°, for MP (80° for PIP) joints, caused by a palpable cord that had never been treated with AA4500.
  • Had a positive "table top test," defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top.
  • Judged to be in good health.

Who cannot join

  • Had a chronic muscular, neurological, or neuromuscular disorder that affected the hands.
  • Had received a treatment for Dupuytren's contracture, including surgery (fasciectomy or surgical fasciotomy), needle aponeurotomy/fasciotomy, or injection of verapamil and/or interferon on the selected primary joint within 90 days before the first dose of study drug.
  • Had a known recent history of stroke, bleeding, a disease process that affected the hands, or other medical condition, which in the investigator's opinion, would make the subject unsuitable for enrollment in the study.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

United States15 sites

  • The Hand and Upper Extremity Center of Georgia, P.C.

    Atlanta, Georgia, 30342

  • Brigham and Women's Hospital, Department of Orthopedic Surgery

    Boston, Massachusetts, 02115

  • Hand Surgery Associates, PC

    Denver, Colorado, 80210

  • Hand Microsurgery & Reconstructive Orthopaedics

    Erie, Pennsylvania, 16550

  • The Indiana Hand Center

    Indianapolis, Indiana, 46260

  • 100 UCLA Medical Plaza, Suite 305

    Los Angeles, California, 90095

  • TRIA Orthopaedic Center

    Minneapolis, Minnesota, 55431

  • Hospital for Special Surgery

    New York, New York, 10021

  • Newton-Wellesley Hospital

    Newton, Massachusetts, 02462

  • Health Research Institute

    Oklahoma City, Oklahoma, 73109

  • Hand Surgery Clinic

    Palo Alto, California, 94304

  • Department of Orthopaedics, Brown University, Rhode Island Hospital

    Providence, Rhode Island, 02905

  • Rockford Orthopedic Associates, Ltd.

    Rockford, Illinois, 61107

  • University Orthopedics Center

    State College, Pennsylvania, 16801

  • SUNY Stony Brook - Department of Orthopedics

    Stony Brook, New York, 11794

Other trials in United States

About this study

Official title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of AA4500 in the Treatment of Subjects With Dupuytren's Contracture

This was a Phase 3, double-blind, randomized, placebo-controlled study conducted in the United States. Subjects with a diagnosis of Dupuytren's contracture in a metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint that resulted in a fixed flexion deformity of at least one finger, other than the thumb, that was at least 20° as measured by finger goniometry and was suitable for injection were randomized 2:1 to receive AA4500 0.58 mg or placebo.

This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 (NCT00528606) and AUX-CC-859 (NCT00533273)) and 7 non-pivotal studies were evaluated.

Being tested
collagenase clostridium histolyticum, Placebo
Medical subject headings
Dupuytren Contracture

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • collagenase clostridium histolyticumBiological

    Also called XIAFLEX®, AA4500

    Subjects could have received up to three injections of AA4500 into the cord of the affected hand. Each injection was separated by at least 30 days. Individual cords may have received up to a maximum of three injections.

  • PlaceboBiological

    Subjects could have received up to three injections of placebo into the cord of the affected hand. Each injection was separated by at least 30 days. Individual cords may have received up to a maximum of three injections.

Study groups in NCT00528606
Study groupRoleWhat they receive
AA4500 0.58 mgExperimentalNot described
Receives: Biological: collagenase clostridium histolyticum
PlaceboPlacebo comparatorNot described
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical Success (Reduction in Contracture to 5° or Less) of the Primary Joint After the Last Injection

    The Primary Outcome Measure for patients treated with AA4500 is the percentage of joints that were successfully treated where "successfully treated" was defined as reduction in contracture to within 0-5° of normal within 30 days of injection.

    The Primary Outcome Measure for placebo treated patients is the percentage of joints that were successfully treated where "successfully treated" was defined as reduction in contracture to within 0-5° of normal within 30 days of injection.

    Measured: Within 30 days after the last injection

Secondary outcomes (8)

  1. Clinical Improvement After the Last Injection

    Clinical Improvement is defined as >= 50% reduction from baseline in degree of contracture within 30 days of the injection.

    Measured: Baseline; within 30 days after the last injection

  2. Percent Reduction From Baseline Contracture After the Last Injection

    Percent change in degree of contracture measured as 100* (baseline contracture - last available post-injection contracture)/baseline contracture.

    Measured: Baseline; within 30 days after the last injection

  3. Change From Baseline Range of Motion After the Last Injection

    Change in degree of motion measured as last available post-injection range of motion - baseline range of motion.

    Measured: Baselin; within 30 days after the last injection

  4. Time to First Achieve Success After the Last Injection

    Measured: Last evaluation visit on which clinical success is achieved through the Day 30 evaluation

  5. Clinical Success (Reduction in Contracture to 5° or Less) After the First Injection

    Clinical Success is defined as reduction in contracture to within 0-5 degrees of normal within 30 days of injection.

    Measured: Within 30 days after first injection

  6. Clinical Improvement After the First Injection

    Clinical Improvement is defined as >= 50% reduction from contracture within 30 days of the first injectionor greater of baseline contracture within 30 days of the injection.

    Measured: Baseline; within 30 days after the first injection

  7. Percent Reduction From Baseline Contracture After the First Injection

    Percent change in degree of contracture measured as 100* (baseline contracture - last available post-injection contracture)/baseline contracture.

    Measured: Baseline, within 30 days after the first injection

  8. Change From Baseline Range of Motion After the First Injection

    Change in degree of motion measured as last available post-injection range of motion - baseline range of motion.

    Measured: Baseline; within 30 days after the first injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2007 (estimated)
  2. Study startAug 2007
  3. Primary completionApr 2008
  4. Study completionApr 2008

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
308 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00528606
Sponsor's protocol ID
AUX-CC-857
Acronym
CORD-I
Status last verified
Oct 2017
First submitted
11 Sep 2007
Last updated
2 Dec 2017
Data monitoring committee
No

Publications

  • Witthaut J, Bushmakin AG, Gerber RA, Cappelleri JC, Le Graverand-Gastineau MP. Determining clinically important changes in range of motion in patients with Dupuytren's Contracture: secondary analysis of the randomized, double-blind, placebo-controlled CORD I study. Clin Drug Investig. 2011 Nov 1;31(11):791-8. doi: 10.1007/BF03256918.

    PubMed 21967070

  • Hurst LC, Badalamente MA, Hentz VR, Hotchkiss RN, Kaplan FT, Meals RA, Smith TM, Rodzvilla J; CORD I Study Group. Injectable collagenase clostridium histolyticum for Dupuytren's contracture. N Engl J Med. 2009 Sep 3;361(10):968-79. doi: 10.1056/NEJMoa0810866.

    PubMed 19726771

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing collagenase clostridium histolyticum in people with Dupuytren's Contracture, run by Endo USA Inc., a Keenova Therapeutics Company at 15 sites 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 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: finished, as of the sponsor's last update on 2 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites 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 phase mean?

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?

Yes. Results are posted in the registry (first posted 22 Oct 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Clinical Success (Reduction in Contracture to 5° or Less) of the Primary Joint After the Last Injection (time frame: Within 30 days after the last injection). 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 NCT00528606, 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 2 Dec 2017.

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