Treatment Of Dupuytren's Contracture With Collagenase Clostridium Histolyticum Injection (Xiapex) (POINT X)
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01229436
First received: October 26, 2010
Last updated: November 28, 2012
Last verified: November 2012
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Purpose
This study will evaluate the impact of Xiapex treatment on the range of motion (ROM) of the affected fingers and the patient and physician reported treatment satisfaction and disease severity and their relation to ROM. Recovery to normal activities, recovery time (How long overall, time to use hand, time to return to work or daily activities, amount of work or daily activity time missed or reduced and affects on productivity and daily activities) will be assessed via patient diary. Use of concomitant analgesic medications will be recorded and total healthcare resource utilization (HCRU).
| Condition | Intervention | Phase |
|---|---|---|
|
Dupuytren's Contracture |
Drug: Xiapex |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Prospective Open-Label Investigation Of The Non-surgical Treatment With Collagenase Clostridium Histolyticum (Xiapex) |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- TPED and PED* (Total Passive Extension Deficit: a sum of the Passive Extension Deficits (PED) in the Metacarpal-Phalangeal, Proximal Interphalangel, and Distal Interphalangeal joints). [ Time Frame: 11 months ] [ Designated as safety issue: No ]
- Change in TPED and PED for each joint treated. [ Time Frame: 11 months ] [ Designated as safety issue: No ]
- Range Of Movement [ Time Frame: 11 months ]
- Patient and physician global assessment of treatment satisfaction and disease severity [ Time Frame: 11 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Type and amount of concomitant pain medications [ Time Frame: 11 months ] [ Designated as safety issue: No ]
- Total recovery time, time to use the hand, daily activities, work vs. hobbies [ Time Frame: 11 months ] [ Designated as safety issue: No ]
- Healthcare resource utilization questionnaire [ Time Frame: 11 months ] [ Designated as safety issue: No ]
- Functional Assesment (URAM scale) [ Time Frame: 11 months ] [ Designated as safety issue: No ]
| Enrollment: | 254 |
| Study Start Date: | December 2010 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Xiapex Injection |
Drug: Xiapex
Xiapex 0.58 mg in diluent, 0.25 ml for MP joints and 0.20 ml for PIP joints, injection to cord over joint using either 26 or 27 gauge needle, maximum 3 injections with 30 days interval between injections to any single site, maximum 5 injections in this protocol
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Presenting with a Dupuytren's contracture of at least 20 degrees caused by a palpable cord in at least one finger other than the thumb.
- Positive "table top test" defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top.
Exclusion Criteria:
- Received a treatment on the selected joint, within 90 days of enrollment in the study, for Dupuytren's contracture including needle aponeurotomy or any surgical procedure
- On anticoagulant medication or has received anticoagulant medication (except aspirin less than 150 mg daily) within 7 days before the first injection
- Has a chronic muscular, neurological, or neuromuscular disorder that affects the hands
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01229436
Locations
| Denmark | |
| Pfizer Investigational Site | |
| Copenhagen, Denmark, 1402 K | |
| Pfizer Investigational Site | |
| Silkeborg, Denmark, 8600 | |
| France | |
| Pfizer Investigational Site | |
| Montpellier cedex 5, France, 34295 | |
| Pfizer Investigational Site | |
| Nice, France, 06000 | |
| Pfizer Investigational Site | |
| Paris, France, Cedex 15 75908 | |
| Pfizer Investigational Site | |
| Paris, France, 75016 | |
| Germany | |
| Pfizer Investigational Site | |
| Bad Neustadt, Germany, 97616 | |
| Pfizer Investigational Site | |
| Berlin, Germany, 10627 | |
| Pfizer Investigational Site | |
| Bonn, Germany, 53123 | |
| Pfizer Investigational Site | |
| Muenster, Germany, 48149 | |
| Pfizer Investigational Site | |
| Nurnberg, Germany, 90471 | |
| Pfizer Investigational Site | |
| Tubingen, Germany, 72076 | |
| Hungary | |
| Pfizer Investigational Site | |
| Miskolc, Hungary, 3526 | |
| Italy | |
| Pfizer Investigational Site | |
| Sesto San Giovanni, Milano, Italy, 20099 | |
| Pfizer Investigational Site | |
| Modena, Italy, 41124 | |
| Pfizer Investigational Site | |
| Savona, Italy, 17100 | |
| Spain | |
| Pfizer Investigational Site | |
| Elche, Alicante, Spain, 03203 | |
| Pfizer Investigational Site | |
| Hospitalet De Llobregat, Barcelona/ Spain, Spain, 08907 | |
| Pfizer Investigational Site | |
| Barcelona, Spain, 08022 | |
| Pfizer Investigational Site | |
| Barcelona, Spain, 08036 | |
| Pfizer Investigational Site | |
| Málaga, Spain, 29010 | |
| Sweden | |
| Pfizer Investigational Site | |
| Malmö, Sweden, SE-205 02 | |
| Pfizer Investigational Site | |
| Stockholm, Sweden, SE 118 83 | |
| Pfizer Investigational Site | |
| Uppsala, Sweden, 751 85 | |
| United Kingdom | |
| Pfizer Investigational Site | |
| Derby, United Kingdom, DE22 3NE | |
| Pfizer Investigational Site | |
| Glasgow, United Kingdom, G4 0SF | |
| Pfizer Investigational Site | |
| Norwich, United Kingdom, NR4 7UY | |
| Pfizer Investigational Site | |
| Southampton, United Kingdom, SO16 6YD | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01229436 History of Changes |
| Other Study ID Numbers: | B1531002 |
| Study First Received: | October 26, 2010 |
| Last Updated: | November 28, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Pfizer:
|
Dupuytren's treatment injection recovery health care resources |
Additional relevant MeSH terms:
|
Contracture Dupuytren Contracture Joint Diseases |
Musculoskeletal Diseases Muscular Diseases Connective Tissue Diseases |
ClinicalTrials.gov processed this record on May 21, 2013