Dupuytren's DiseasePhase 4NCT01226121

Safety and Efficacy of Delayed Manipulation After Xiaflex Treatment in Subjects With Dupuytren's Contracture

A Phase 4 study testing Clostridial collagenase injectable in people with Dupuytren's Disease, run by Indiana Hand to Shoulder Center at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to determine if of manipulation of digits following collagenase injection for treatment of Dupuytren's contracture is effected by the amount of time between injection and manipulation. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Dupuytren's Disease
What is being tested?: Clostridial collagenase injectable
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 37 participants
Where: 2 sitesUnited States
Study dates: Dec 2010to Dec 2012
Phase: Phase 4
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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Adult subjects (> 18 years) of either gender with an metacarpophalangeal joint contracture and a palpable cord of > 20 degrees of a digit (excluding the thumb) due to Dupuytren's contracture

Who cannot join

Any subject who has had prior surgical, percutaneous needle aponeurotomy or Xiaflex treatment for Dupuytren's contracture.
Any subject using anti-coagulant therapy other than low dose aspirin (up to 150mg/day).
Any subject in the opinion of the MD investigators with chronic, severe or terminal medical illness which would make them unsuitable for study participation.
Any subject with known allergy to Xiaflex (Clostridial collagenase).
Any subject who cannot conform to the study visit schedule

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Indiana Hand to Shoulder Center
Indianaplis, Indiana, 46260
Stony Brook University
Stony Brook, New York, 11794

Other trials in United States

About this study

Official title: A Post Market, Open-Label Study of the Safety and Efficacy of Delayed Manipulation After Xiaflex Treatment in Subjects With Dupuytren's Contracture

Read the detailed description

Patients with Metacarpophalangeal joint contractures caused by Dupuytren's disease will be evaluated as to the timing of the finger manipulation procedure that is performed following collagenase injection. Three groups will be evaluated: group 1 will have the manipulation procedure on the day following collagenase injection, group 2 will have the manipulation procedure on the second day following collagenase injection,and group 3 will have the manipulation procedure on the fourth day following collagenase injection,

Conditions: Dupuytren's Disease
Being tested: Clostridial collagenase injectable
Keywords: dupuytren, dupuytren's
Medical subject headings: Dupuytren Contracture

What participants receive

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

Clostridial collagenase injectableBiological
Finger manipulation performed 1, 2, or 4 days following collagenase injection

Study groups in NCT01226121
Study group	Role	What they receive
Day 1 manipulation	Active comparator	Finger manipulation one day following Clostridial collagenase injectable Receives: Biological: Clostridial collagenase injectable
Day 2 manipulation	Active comparator	Finger manipulation two days following Clostridial collagenase injectable Receives: Biological: Clostridial collagenase injectable
Day 4 manipulation	Active comparator	Finger manipulation four days following Clostridial collagenase injectable Receives: Biological: Clostridial collagenase injectable

What is being measured

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

Percentage of Patients With Clinical Improvement (> 50% Reduction in Contracture)
Measured: 30 days after injection

Secondary outcomes (1)

Percentage of Patients Obtaining Clinical Success at 90 Days (<=5 Degree Residual Contracture)
Measured: 90 days

Timeline

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

Dec 2010Dec 2012

First posted21 Oct 2010 (estimated)
Study startDec 2010
Primary completionDec 2012
Study completionDec 2012

Why it stopped: difficulty enrolling additional patients

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Dupuytren's DiseaseStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01226121
Sponsor's protocol ID: IHtSC-Delay 101
Status last verified: May 2014
First submitted: 20 Oct 2010
Last updated: 16 Jun 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Radiation Therapy for Dupuytren's Contracture Following Non-Surgical Release
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Skin Involvement in Dupuytren Surgical Treatment Outcome
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Safety and Efficacy Study of Collagenase CNT201 Injection for Treatment of Dupuytren's Contracture
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All Dupuytren's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Post Market, Open-Label Study of the Safety and Efficacy of Delayed Manipulation After Xiaflex Treatment in Subjects With Dupuytren's Contracture
ClinicalTrials.gov ID: NCT01226121
Acronym / sponsor ID: IHtSC-Delay 101
Conditions: Dupuytren's Disease
Keywords: dupuytren, dupuytren's
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: difficulty enrolling additional patients
Enrolment: 37 participants (actual)
Lead sponsor: Indiana Hand to Shoulder CenterUniversity, hospital or other
Collaborators: Stony Brook University
Study start: Dec 2010
Primary completion: Dec 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 21 Oct 2010 (estimated)
Results: Posted 16 Jun 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Day 1 manipulation	Active comparator	Biological: Clostridial collagenase injectableFinger manipulation one day following Clostridial collagenase injectable
Day 2 manipulation	Active comparator	Biological: Clostridial collagenase injectableFinger manipulation two days following Clostridial collagenase injectable
Day 4 manipulation	Active comparator	Biological: Clostridial collagenase injectableFinger manipulation four days following Clostridial collagenase injectable

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Adult subjects (> 18 years) of either gender with an metacarpophalangeal joint contracture and a palpable cord of > 20 degrees of a digit (excluding the thumb) due to Dupuytren's contracture

Key exclusion criteria (5 listed)

Any subject who has had prior surgical, percutaneous needle aponeurotomy or Xiaflex treatment for Dupuytren's contracture.
Any subject using anti-coagulant therapy other than low dose aspirin (up to 150mg/day).
Any subject in the opinion of the MD investigators with chronic, severe or terminal medical illness which would make them unsuitable for study participation.
Any subject with known allergy to Xiaflex (Clostridial collagenase).
Any subject who cannot conform to the study visit schedule

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
Clostridial collagenase injectableFinger manipulation performed 1, 2, or 4 days following collagenase injection	Biological	Day 1 manipulation, Day 2 manipulation, Day 4 manipulation

Primary outcome

Percentage of Patients With Clinical Improvement (> 50% Reduction in Contracture)
Time frame: 30 days after injection

1 secondary outcome

Percentage of Patients Obtaining Clinical Success at 90 Days (<=5 Degree Residual Contracture)
Time frame: 90 days

Results and safety

Results posted to the registry on 16 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Day 1 Manipulation	13	11
Day 2 Manipulation	11	11
Day 4 Manipulation	13	12

Primary outcome: Percentage of Patients With Clinical Improvement (> 50% Reduction in Contracture)

Time frame: 30 days after injection. Number. Unit: percentage of participants

Measure	Day 1 Manipulation n = 12	Day 2 Manipulation n = 11	Day 4 Manipulation n = 13
Value	92	91	85

1 secondary outcome is reported in the full results.

Adverse events

Time frame: data collected for 90 day period patients were followed following injection. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Day 1 Manipulation	0 of 13 (0%)	13 of 13 (100%)	Not reported
Day 2 Manipulation	0 of 11 (0%)	11 of 11 (100%)	Not reported
Day 4 Manipulation	0 of 13 (0%)	13 of 13 (100%)	Not reported

Limitations and caveats (from the sponsor): Study was terminated early due to slow enrollment

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19726771Hurst 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.

Related trials for Dupuytren's Disease

Not yet recruiting
Kinesitherapy Plus Osteopathy After Surgery for Dupuytren Disease
Dupuytren Disease
Not yet recruitingPhase 3
DEPART Study at Yale
Dupuytren's Contracture
Recruiting
Radiation Therapy for Dupuytren's Contracture Following Non-Surgical Release
Dupuytren Contracture
Active, not recruiting
Skin Involvement in Dupuytren Surgical Treatment Outcome
Dupuytren Disease
RecruitingPhase 1/2
Safety and Efficacy Study of Collagenase CNT201 Injection for Treatment of Dupuytren's Contracture
Dupuytren Contracture, Dupuytren Disease of Finger

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.

F. Thomas D. Kaplan, MD principal investigator

Indiana Hand to Shoulder Center

Lawrence C Hurst, MD principal investigator

Stony Brook University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Clostridial collagenase injectable in people with Dupuytren's Disease, run by Indiana Hand to Shoulder Center at 2 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 1 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 16 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 16 Jun 2014). 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?

Percentage of Patients With Clinical Improvement (> 50% Reduction in Contracture) (time frame: 30 days after 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 NCT01226121, 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 16 Jun 2014.