[No standalone website (unbranded, no questionnaire)] A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

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Study’s contact

Call center

877‐277‐8566

Email address

IR-CTRegistration@allergan.com

Condition

Diabetes Mellitus,Gastroparesis

Treatment type

Interventional

Investigational product

Placebo

Phase

Phase 3

Sponsor

Allergan

ClinicalTrials.gov identifier

NCT03383146

Study number

RLM-MD-04

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About the study

A 52-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG) with respect to the core signs and symptoms of diabetic gastroparesis.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria
  1. Two different groups of participants may enter into the study:
  2. Participants must meet all the inclusion criteria at screening (Visit 1) and at the end of the Run-in Period (Visit 3) for randomization into the Treatment Period of RLM-MD-01 (NCT03285308) or RLM-MD-02 (NCT03426345) (including compliance with dosing,entry of diary data into the DGSSD during the lead-in study Run-in Period). Participants are eligible for randomization into Study RLM-MD-04 if:
  3. 1) They had no vomiting episodes recorded in the DGSSD and had an average daily DGSSS ≥ 12 at the end of the lead-in study Run-in Period. OR
  4. 2) They had vomiting episodes recorded in the DGSSD but had an average daily DGSSS of ≥ 12 and < 16 at the end of the lead-in study Run-in Period. In the current study, these "rollover participants" will enter the study at Visit 1 (Randomization); they will not undergo Screening (Visit -2) or the Run-in Visit (Visit -1) procedures Patients who undergo screening and run-in procedures in Study RLM-MD-04 are "de novo participants". To be eligible for randomization in the current study, de novo participants must meet all Screening and Run-in Period criteria for Study RLM-MD-04, including: 1. At Screening, be male or female age 18 years and older, T1DM or T2DM with controlled and stable blood glucose levels and HbA1c ≤ 11%; symptoms suggestive of DG for at least 3 months (one of which must be nausea), with mechanical obstruction of the GI tract as the cause of symptoms having been ruled out; 2. After Run-in Period: Evidence of compliance during the Run-in Period with the use of the electronic hand-held device for entry of data, with twice daily SC injections of the study treatment, and no treatment with GI promotility agents; a score of ≥ 12 for the average of the daily DGSSS measured during the Run-in Period, delayed GE by gastric emptying breath test (GEBT).
Exclusion criteria
  1. Participants with a know allergy or hypersensitivity to the study treatments and their excipients (i.e., mannitol or phenol)
  2. Rollover participants will be excluded from this study if any of the lead-in study exclusion criteria apply at Screening and at the end of the Run-in Period for randomization into the Treatment Period of the study

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

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