Trial · NCT01407068
Administration of Two Injections for Multiple Dupuytren's Contractures
NCT01407068, Phase 3, Completed, Endo USA Inc., a Keenova Therapeutics Company; results first posted 2015-02-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Administration of Two Injections for Multiple Dupuytren's Contractures. Trials, record NCT01407068. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01407068
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Administration of Two Injections for Multiple Dupuytren's Contractures
- NCT number
- NCT01407068
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 60 participants, actual
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Conditions
- Dupuytren's Contracture
- Interventions
- AA4500 collagenase clostridium histolyticum
- First posted
- 2011-08-01
- Last updated
- 2017-10-05
- Results first posted
- 2015-02-20
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Total Fixed Flexion | 30 days after last injection | Total fixed flexion is defined as the sum of the fixed flexion contractures of the two joints receiving treatment. Change in fixed-flexion contracture is measured in degrees where a decrease of 100% would correspond to a reduction in contracture to 0 degrees |
| Primary | Change in Total Range of Motion | 30 days after last injection | The total range of motion is the sum of the range of motion measurements of the two treated joints. Range of motion is defined as difference between full flexion angle and full extension angle expressed in degrees. |
| Secondary | Subject Satisfaction With Treatment | 60 days after last injection | At the Day 60 follow-up visit, each subject will be asked to rate his/her satisfaction with treatment as follows: 1. Very Satisfied 2. Quite Satisfied 3. Neither Satisfied nor Dissatisfied 4. Quite Dissatisfied 5. Very Dissatisfied |
| Secondary | Investigator Assessment of Improvement With Treatment | 60 days after last injection | At the Day 60 follow-up visit, the investigator will determine the degree of improvement in the severity of the subject's treated finger(s) compared with screening as follows: 1. Very Much Improved 2. Much improved 3. Minimally Improved 4. No Change 5. Minimally Worse 6. Much Worse 7. Very Much Worse |
| Secondary | Clinical Success by Joint Type | 30 days after injection | Clinical success is defined as a reduction in fixed flexion contracture to 5° or less 30 days after injection of AA4500. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Total Fixed Flexion | 30 days after last injection | Efficacy analysis is based of the intent-to-treat population (ITT). The population is defined as all enrolled subjects who received two injections of AA4500 and had at least one-post-injection measurement. | percentage of contracture change | MEAN |
| SECONDARY | Subject Satisfaction With Treatment | 60 days after last injection | Efficacy analysis is based of the intent-to-treat population (ITT). The population is defined as all enrolled subjects who received two injections of AA4500 and had at least one-post-injection measurement. | participants | NUMBER |
| SECONDARY | Investigator Assessment of Improvement With Treatment | 60 days after last injection | Efficacy analysis is based of the intent-to-treat population (ITT). The population is defined as all enrolled subjects who received two injections of AA4500 and had at least one-post-injection measurement. | participants | NUMBER |
| PRIMARY | Change in Total Range of Motion | 30 days after last injection | Efficacy analysis is based of the intent-to-treat population (ITT). The population is defined as all enrolled subjects who received two injections of AA4500 and had at least one-post-injection measurement. | degrees | MEAN |
| SECONDARY | Clinical Success by Joint Type | 30 days after injection | Efficacy analysis is based of the intent-to-treat population (ITT). The population is defined as all enrolled subjects who received two injections of AA4500 and had at least one-post-injection measurement. | number of joints | NUMBER |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in Total Fixed Flexion | AA4500 | 75.5 | Standard Deviation 24.11 | percentage of contracture change | |
| Subject Satisfaction With Treatment | AA4500 | Very satisfied | 36 | participants | |
| Subject Satisfaction With Treatment | AA4500 | Quite satisfied | 17 | participants | |
| Subject Satisfaction With Treatment | AA4500 | Neither satisfied nor dissatisfied | 5 | participants | |
| Subject Satisfaction With Treatment | AA4500 | Quite dissatisfied | 1 | participants | |
| Subject Satisfaction With Treatment | AA4500 | Very dissatisfied | 1 | participants | |
| Subject Satisfaction With Treatment | AA4500 | Not done | 0 | participants | |
| Investigator Assessment of Improvement With Treatment | AA4500 | Very much improved | 33 | participants | |
| Investigator Assessment of Improvement With Treatment | AA4500 | Much improved | 22 | participants | |
| Investigator Assessment of Improvement With Treatment | AA4500 | Minimally improved | 4 | participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AA4500 | 60 | |
| Overall Study | COMPLETED | AA4500 | 60 | |
| Overall Study | NOT COMPLETED | AA4500 | 0 |
Source ClinicalTrials.gov
Adverse events14
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | oedema peripheral | General disorders | AA4500 | 49 | 60 | 53 |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | AA4500 | 49 | 60 | 53 |
| other | Contusion | Injury, poisoning and procedural complications | AA4500 | 48 | 60 | 55 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | AA4500 | 22 | 60 | 23 |
| other | Pruritus | Skin and subcutaneous tissue disorders | AA4500 | 20 | 60 | 20 |
| other | Skin laceration | Injury, poisoning and procedural complications | AA4500 | 15 | 60 | 16 |
| other | Injection site haematoma | General disorders | AA4500 | 11 | 60 | 14 |
| other | Injection site swelling | General disorders | AA4500 | 8 | 60 | 9 |
| other | Blood blister | Skin and subcutaneous tissue disorders | AA4500 | 7 | 60 | 7 |
| other | Ecchymosis | Skin and subcutaneous tissue disorders | AA4500 | 3 | 60 | 3 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AA4500 | ||
| Total, other adverse events | AA4500 | 60 | 60 |
| Total, serious adverse events | AA4500 | 3 | 60 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01407068
GET https://conductscience.org/api/trials/v1/NCT01407068/registered