The Duration Study

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00210730
• Date of registration: 13/09/2005
• Primary sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Public title: The Duration Study
• Scientific title: An Open Label Randomized Study To Evaluate The Response Rate Of Epoetin Alfa (PROCRIT?) Versus No/Delayed PROCRIT Treatment In Patients With Cancer And Persistent Chemotherapy-Induced Myelosuppression (Anemia)
• Date of first enrolment: June 2004
• Target sample size: 2
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00210730
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Contacts

• Name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
• Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Key inclusion & exclusion criteria

Inclusion Criteria:

- Histologically confirmed diagnosis of non-myeloid malignancy

- Baseline hemoglobin value >= 11 g/dL and <= 12 g/dL unrelated to transfusion

- Female patients with reproductive potential must have a negative serum pregnancy test
at screening. Patients must have signed an informed consent

Exclusion Criteria:

- Uncontrolled hypertension

- History (within 6 months) of uncontrolled cardiac arrhythmias, or history of
pulmonary emboli, deep vein thrombosis, ischemic stroke, other arterial or venous
thrombotic events (excluding superficial thromboses), or known history of chronic
coagulation disorder

- Transfusion within 28 days prior to first dose

- Planned myelosuppressive chemotherapy or radiation during study and no prior
chemotherapy within 8 weeks or radiation within 4 weeks of study entry.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Anemia

Intervention(s)

Drug: epoetin alfa

Primary Outcome(s)

The primary efficacy endpoint is hematologic response, defined as follows: Transfusion free during study, and the average of post baseline Hb values > 11 g/dL without a post baseline Hb < 10 g/dL.

Secondary Outcome(s)

Proportion of patients transfused, time to first transfusion, proportion of patients with two post baseline Hb values > 12 g/dL, mean final Hb, mean lowest Hb, proportion of patients with Hb < 10, weekly Hb, QOL

Secondary ID(s)

CR004591

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ortho Biotech Products, L.P.