NCT00032682 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Kavanagh JJ, Copeland LJ, Gershenson DM, Saul PB, Wharton JT, Rutledge FN
Continuous-infusion vinblastine in refractory carcinoma of the cervix: a phase II trial. Gynecol Oncol. 1985 Jun;21(2):211-4.
Robinson CB, Fritch M, Hullett L, Petersen MA, Sikkema S, Theuninck L, Timmer K
Development of a protocol to prevent opioid-induced constipation in patients with cancer: a research utilization project. Clin J Oncol Nurs. 2000 Mar-Apr;4(2):79-84.
Wright PS, Thomas SL
Constipation and diarrhea: the neglected symptoms. Semin Oncol Nurs. 1995 Nov;11(4):289-97. Review.

A Pilot Study Evaluating the Assessment Process for Constipation in Pediatric Oncology Patients Who Are Receiving Vinca Alkaloids and/or Narcotics

Clinical trial NCT00032682 - References