Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT02788565
NCT02788565CompletedNot Applicable

SOMATOSTATIN TREATMENT EXPERIENCE TRIAL An Observational Cross Sectional Trial Investigating Quality of Life, Treatment Experience and Direct Cost of Treatment With Somatostatin Analogues in Subjects With Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETS)

Ipsen2 sites in 1 country156 target enrollmentStarted: March 2016Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Ipsen
Enrollment
156
Locations
2
Primary Endpoint
Proportion of subjects with injection problems according to the subject
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Data from this study will contribute additional knowledge regarding patient outcomes and direct somatostatin analogue (SSA) treatment related costs in clinical practice in the Nordic countries. Such knowledge can be of importance in a treatment decision, decision support for development of care, follow up and training of both patients and primary care nurses.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Signed informed consent
  • •Diagnosed with a Gastroenteropancreatic Neuroendocrine Tumour (GEP-NET) and treated with SSA for at least three months but not more than 3 years
  • •GEP-NET proliferation index Ki 67 <10%
  • •Over 18 years of age

Exclusion Criteria

  • •No specific exclusion criteria defined

Outcomes

Primary Outcomes

Proportion of subjects with injection problems according to the subject

Time Frame: Day 1

Subject questionnaire asks "In your opinion, how did the last injection go?", subject chooses either 'no problems' or 'problems occurred'.

Secondary Outcomes

  • Mean number of packs of H01CB03 and H01CB02 purchased.(Retrospective data collection of a 1 year period)
  • Mean number of two consecutive dispensed prescriptions of H01CB03, H01CB02 within seven days during the pre-specified one-year period of retrospective data extraction.(Retrospective data collection of a 1 year period)
  • Median number of two consecutive dispensed prescriptions of H01CB03, H01CB02 within seven days during the pre-specified one-year period of retrospective data extraction.(Retrospective data collection of a 1 year period)
  • Median time - visits to primary care for injections; visits to treating physician at hospital; time to travel(Day 1)
  • Median frequency of visits to treating physician in hospital will be derived as number of (frequency) of revisits recorded in the subject questionnaire.(Day 1)
  • Median time for giving injections of SSA in subjects, derived as the time reported in the nurse questionnaire.(Day 1)
  • Quality of life, mean physical health score in SF-12 derived according to the SF-12 manual.(Day 1)
  • Quality of life, mean mental health score in SF-12 derived according to the SF-12 manual.(Day 1)
  • Median number of packs of H01CB03 and H01CB02 purchased.(Retrospective data collection of a 1 year period)
  • Proportion of nurses who reported "moderately" or "very" or "very much" confidence in giving injections(Day 1)
  • Subject experience: proportion of subjects reporting "much" or "very much" anxiety in subject questionnaire.(Day 1)

Investigators

Sponsor
Ipsen
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

Loading locations...

Similar Trials

Completed
Phase 4
Identifying the Effect of Somatostatin Treatment in Early Postoperative Simple Small Bowel ObstructionSmall Bowel Obstruction
NCT01082627Nanjing PLA General Hospital44
Active, not recruiting
Phase 2
Somatostatin Analogues With Perioperative Antibiotics Versus Prolonged AntibioticsPancreatic Diseases
NCT04329039Mayo Clinic103
Completed
Not Applicable
Randomized, placebo controlled, patient and observer masked study to evaluate the efficacy of treatment with Sandostatin LAR 20 mg i.m. or placebo every 4 weeks during 6 months in 120 patients with exudative age-related macular degeneration.
NL-OMON25954120
Terminated
Not Applicable
Study to Evaluate Outcomes of Patients Receiving Treatment for Wound Care, Pain Management or Surface Skin Scar TherapyFungal InfectionChronic Pain
NCT02445235Bracane Company88
Completed
Not Applicable
An Observational Study to Evaluate Effectiveness and Safety of Amosartan Plus TabletHypertension,Essential
NCT05462535Hanmi Pharmaceutical Company Limited4,785