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NCT02299089 · OUTCOME

CAM2029 Effect on Insulin-like Growth Factor (IGF-1) (Acromegaly)

Phase II Study of Subcutaneous Inj. Depot of Octreotide in Patients With Acromegaly and Neuroendocrine Tumours (NETs) · Source last updated 2017-12-15

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Day 84

What was measured

Data is presented as number of patients * Within the reference limits (see below) * Above ULN (Upper Limits of Normal) In the Acromegaly group both males and females were included the age was between 42-70 years. The IGF normal range for the different genders and age are presented below. REFERENCE VALUES Males (NMOL/L) 8.34-27.44 (41-45 years) 7.7-26.36 (46-50 years) 7.3-26.34 (51-55 years) 6.64-25.44 (56-60 years) 6.17-25.02 (61-65 years) 5.96-25.48 (66-70 years) Females (NMOL/L) 8.06-26.89 (41-45 years) 7.39-25.44 (46-50 years) 6.92-24.98 (51-55 years) 5.92-22.7 (56-60 years) 5.42-21.96 (61-65 years) 5.07-21.97 (66-70 years)

Analysis population: Pharmacokinetic population (5 acromegaly subjects total)

Groups in this outcome

CAM2029 10 mg q2w (Acromegaly)

CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks octreotide FluidCrystal® injection depot

CAM2029 20 mg q4w (Acromegaly)

CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly octreotide FluidCrystal® injection depot

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
CAM2029 10 mg q2w (Acromegaly)3
CAM2029 20 mg q4w (Acromegaly)2

Reported measurements

Within Normal Limits
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CAM2029 10 mg q2w (Acromegaly)2Not reportedNot reportedNot reportedNot reported
CAM2029 20 mg q4w (Acromegaly)1Not reportedNot reportedNot reportedNot reported
Above ULN
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CAM2029 10 mg q2w (Acromegaly)1Not reportedNot reportedNot reportedNot reported
CAM2029 20 mg q4w (Acromegaly)1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
    title
    Within Normal Limits
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
    title
    Above ULN
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      2
    units
    Participants
description
Data is presented as number of patients * Within the reference limits (see below) * Above ULN (Upper Limits of Normal) In the Acromegaly group both males and females were included the age was between 42-70 years. The IGF normal range for the different genders and age are presented below. REFERENCE VALUES Males (NMOL/L) 8.34-27.44 (41-45 years) 7.7-26.36 (46-50 years) 7.3-26.34 (51-55 years) 6.64-25.44 (56-60 years) 6.17-25.02 (61-65 years) 5.96-25.48 (66-70 years) Females (NMOL/L) 8.06-26.89 (41-45 years) 7.39-25.44 (46-50 years) 6.92-24.98 (51-55 years) 5.92-22.7 (56-60 years) 5.42-21.96 (61-65 years) 5.07-21.97 (66-70 years)
groups
  1. description
    CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks octreotide FluidCrystal® injection depot
    id
    OG000
    title
    CAM2029 10 mg q2w (Acromegaly)
  2. description
    CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly octreotide FluidCrystal® injection depot
    id
    OG001
    title
    CAM2029 20 mg q4w (Acromegaly)
param Type
NUMBER
population Description
Pharmacokinetic population (5 acromegaly subjects total)
reporting Status
POSTED
time Frame
Day 84
title
CAM2029 Effect on Insulin-like Growth Factor (IGF-1) (Acromegaly)
type
SECONDARY
unit Of Measure
participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice