Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 40 of 40 for:    somatostatin analogues | Neuroendocrine Tumors

Real-world Evidence Study EvaLuating PAtient-Reported Outcomes With XERMELO (RELAX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03223428
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
Lexicon Pharmaceuticals

Brief Summary:
The primary objective of the study is to estimate the proportion of carcinoid syndrome (CS) patients who are satisfied with their overall symptom control, 6 months after initiating treatment with telotristat ethyl (XERMELO).

Condition or disease Intervention/treatment
Carcinoid Syndrome Drug: Xermelo

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 643 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: An Observational Study to Evaluate the Real-world Experience of Patients Who Are Initiating Treatment With Telotristat Ethyl (XERMELO™)
Actual Study Start Date : June 22, 2017
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021


Group/Cohort Intervention/treatment
Carcinoid Syndrome patients initiating Xermelo
Patients with Carcinoid Syndrome who are initiating treatment with XERMELO.
Drug: Xermelo
This study will include patients with carcinoid syndrome who are initiating treatment with XERMELO.
Other Name: Telotristat ethyl




Primary Outcome Measures :
  1. Proportion of patients who are satisfied with their overall symptom control [ Time Frame: 6 months ]
    The proportion of CS patients who are satisfied with their overall symptom control, 6 months after initiating treatment with telotristat ethyl (XERMELO).


Secondary Outcome Measures :
  1. Proportion of patients reporting satisfaction of CS-related diarrhea control [ Time Frame: 6 months ]
  2. Proportion of patients reporting satisfaction of CS- related flushing control [ Time Frame: 6 months ]
  3. Proportion of patients reporting reduction in rescue somatostatin analog (SSA) use [ Time Frame: 6 months ]
  4. Proportion of patients reporting reduction in the dose of long-acting SSA injection [ Time Frame: 6 months ]
  5. Proportion of patients reporting reduction in the frequency of long-acting SSA injection [ Time Frame: 6 months ]
  6. Proportion of patients reporting an overall improvement in CS control after initiating XERMELO based on patient global impression of change (PGIC) [ Time Frame: 6 months ]
  7. Proportion of patients that had reduction in in work-related absenteeism, presenteeism, activity impairment, and overall productivity loss based on Worker Productivity and Activity Impairment: Specific Health Problem v2.0 (WPAI- SHP) [ Time Frame: 6 months ]
  8. Proportion of patients reporting weight gain [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
The study will include patients with CS and who are initiating treatment with XERMELO.
Criteria

Inclusion Criteria:

  • Adult, ≥18 years of age at the time of informed consent
  • A new, valid prescription for XERMELO
  • Initiating XERMELO for the treatment of carcinoid syndrome
  • Able and willing to provide informed consent prior to participation in the study

Exclusion Criteria:

  • Unable to understand and read English
  • Unable to access the internet
  • Prior exposure to XERMELO

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03223428


Contacts
Layout table for location contacts
Contact: Karie Arnold 281-863-3000 karnold@lexpharma.com

Locations
Layout table for location information
United States, North Carolina
RTI-HS Recruiting
Research Triangle Park, North Carolina, United States, 27709
Sponsors and Collaborators
Lexicon Pharmaceuticals
Investigators
Layout table for investigator information
Study Director: Suman Wason, MD Lexicon Pharmaceuticals, Inc.

Additional Information:

Layout table for additonal information
Responsible Party: Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03223428     History of Changes
Other Study ID Numbers: LX1606.1-401-CS
LX1606.401 ( Other Identifier: Lexicon Pharmaceuticals, Inc. )
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes

Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoid Tumor
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Malignant Carcinoid Syndrome
Serotonin Syndrome
Adenocarcinoma
Carcinoma
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders