NCT02183740 - 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)

Blekken LE, Nakrem S, Gjeilo KH, Norton C, Mørkved S, Vinsnes AG
Feasibility, acceptability, and adherence of two educational programs for care staff concerning nursing home patients' fecal incontinence: a pilot study preceding a cluster-randomized controlled trial. Implement Sci. 2015 May 23;10:72. doi: 10.1186/s13012-015-0263-8.
Blekken LE, Vinsnes AG, Gjeilo KH, Mørkved S, Salvesen Ø, Norton C, Nakrem S
Effect of a multifaceted educational program for care staff concerning fecal incontinence in nursing home patients: study protocol of a cluster randomized controlled trial. Trials. 2015 Mar 1;16:69. doi: 10.1186/s13063-015-0595-3.

Effect of an Educational Program for Staff in Nursing Homes Concerning Patients Fecal Incontinence: a Cluster-randomized Controlled Trial

Clinical trial NCT02183740 - References