ACTiF- Assessment of Closed Tibial Fractures

NCT00533377 | Completed Phase 2

• 1 other identifier: A3241010
• Study Type: interventional
• Target: 276
• Locations: 11 countries
• Sites: 56

Brief Summary

The purpose of this study is to find out the good and bad effects of an investigational drug called CP-533,536 in patients with closed fracture of the tibial shaft undergoing internal fixation using reamed inter-locked IM nailing procedure

Conditions

Tibial Fractures

Outcome Measures

Primary Outcomes (1)

• Time to fracture healing compared with placebo

  24 weeks

Secondary Outcomes (5)

• Proportion of subjects who require a secondary intervention to promote fracture healing

  48 weeks

• Impact on the subject's ability to return to normal function, general health status, work productivity, and degree of pain at fracture site compared with placebo and Standard of Care groups

  24 weeks

• Time to fracture healing compared with Standard of Care

  24 weeks

• Proportion of patients healed compared with placebo

  16 weeks

• Time to regular callus formation compared with placebo

  24 weeks

Study Arms (6)

CP-533,536 Dose Level 2

EXPERIMENTAL

Drug: CP-533, 536

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Standard of Care

OTHER

Procedure: Standard of Care

CP-533,536 Dose Level 1

EXPERIMENTAL

Drug: CP-533,536

CP-533,536 Dose Level 3

EXPERIMENTAL

Drug: CP-533,536

CP-533.536 Dose Level 4

EXPERIMENTAL

Drug: CP-533,536

Interventions

CP-533, 536 DRUG

Active study drug

CP-533,536 Dose Level 2

Placebo DRUG

Placebo vehicle

Placebo

Standard of Care PROCEDURE

Standard surgical procedure

Standard of Care

CP-533,536 DRUG

Active study drug

CP-533,536 Dose Level 1

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females 17 years or older with confirmed closure of the tibial epiphyses, with a closed fracture of the tibial diaphysis undergoing treatment with reamed locked IM nailing procedure and the absence of an associated compartment syndrome or vascular injury;
• Closed tibial fractures Types A, B \& C (See OTA fracture classification) can be included.

You may not qualify if:

• Previous fractures of the same tibia that may impact nailing procedure or impaired visibility of current fracture or a history of osteomyelitis;
• Subjects with any other clinically significant injuries, which may significantly impair weight bearing of the affected limb;
• Subjects with a fracture gap of \>1cm after initial surgery and prior to drug administration;
• Any other planned invasive or non invasive interventions intended to promote bone healing of the tibial fracture under study are not allowed in the first 24 weeks after treatment.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (56)

Pfizer Investigational Site

Wichita, Kansas, 67214, United States

Location

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Worcester, Massachusetts, 01655, United States

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Minneapolis, Minnesota, 55415, United States

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Columbia, Missouri, 65212, United States

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Durham, North Carolina, 27710, United States

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Chattanooga, Tennessee, 37403, United States

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Dallas, Texas, 75246, United States

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Houston, Texas, 77030, United States

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Salt Lake City, Utah, 84108, United States

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Morgantown, West Virginia, 26505, United States

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Morgantown, West Virginia, 26506, United States

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Herston, Queensland, 4029, Australia

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Adelaide, South Australia, 5000, Australia

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Sarajevo, 71000, Bosnia and Herzegovina

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Red Deer, Alberta, T4N 4E7, Canada

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Red Deer, Alberta, T4N 6V7, Canada

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Hamilton, Ontario, L8L 2X2, Canada

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London, Ontario, N6A 4G5, Canada

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London, Ontario, N6A 5W9, Canada

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Ottawa, Ontario, K1Y 4E9, Canada

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Sarnia, Ontario, N7T 4P3, Canada

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Sarnia, Ontario, N7T 4R9, Canada

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Sarnia, Ontario, N7T 6H3, Canada

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Sarnia, Ontario, N7T 6H5, Canada

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Sarnia, Ontario, N7T 6H6, Canada

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Sarnia, Ontario, N7T 6S3, Canada

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Sarnia, Ontario, N7T G6G, Canada

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Toronto, Ontario, M5B 1W8, Canada

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Varaždin, 42000, Croatia

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Zagreb, 10000, Croatia

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Secunderabad, Andhra Pradesh, 500 003, India

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Bangalore, Karnataka, 560 001, India

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Bangalore, Karnataka, 560 034, India

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Mangalore, Karnataka, 575 001, India

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Mumbai, Maharashtra, 400 012, India

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Ludhiana, Punjab, 141008, India

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Lucknow, Uttar Pradesh, 226003, India

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Nagoya, Aichi-ken, Japan

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Kitakyushu-shi, Fukuoka, Japan

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Mizumaki-cho Onga-gun, Fukuoka, Japan

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Okawa-shi, Fukuoka, Japan

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Fujisawa-shi, Kanagawa, Japan

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Kouchi, Kouchi-ken, Japan

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Sasebo-Shi, Nagasaki, Japan

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Toda-shi, Saitama, Japan

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Shinagawa-ku, Tokyo, Japan

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Saint Petersburg, 193312, Russia

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Saint Petersburg, 195427, Russia

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Parktown, Gauteng, 2193, South Africa

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Glenwood, KwaZulu-Natal, 4000, South Africa

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Soweto, 2013, South Africa

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Tygerberg, 7505, South Africa

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Seville, Sevilla, 41013, Spain

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Ankara, 06100, Turkey (Türkiye)

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Istanbul, 34098, Turkey (Türkiye)

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Pfizer Investigational Site

Izmir, 35100, Turkey (Türkiye)

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Tibial Fractures

Interventions

Standard of Care; CP533536

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2007
• First Posted: September 21, 2007
• Study Start: January 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: February 17, 2012

Record last verified: 2012-02

Locations

IN (7); JP (9); TU (3); CR (2); US (11); ES (1); RU (2); ZA (4); CA (14); BO (1); AU (2)