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NCT02299089 · OUTCOME

Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) AUC

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
MEAN
Unit
day*ng/mL
Interval / dispersion
Standard Deviation
Time frame
Pre-dose; study Day -28- to Day 0 (PK analysis:Sandostatin (LAR®) sampling time points: 0, 1hour, 24hours, 7days, 14days, 21days and 28days)

What was measured

Pharmacokinetics (PK) of octreotide after injection of Sandostatin Long-acting Release (LAR) was determined for the dosing period Day -28 to Day 0; AUC0-28d (day\*ng/mL). AUC0-28d: AUC from 0 to 28 days over the final dosing interval (day\*ng/mL) for Sandostatin LAR.

Analysis population: Pharmacokinetic population

Groups in this outcome

Sandostatin LAR 10 mg (Acromegaly)

Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR

Sandostatin LAR 30mg (Acromegaly)

Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR

Sandostatin LAR 20 mg (NET)

Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR

Sandostatin LAR 30 mg (NET)

Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR

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

Analysis denominator · Participants

GroupSource count
Sandostatin LAR 10 mg (Acromegaly)1
Sandostatin LAR 30mg (Acromegaly)4
Sandostatin LAR 20 mg (NET)1
Sandostatin LAR 30 mg (NET)4

Reported measurements

Source class 1
Values in day*ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Sandostatin LAR 10 mg (Acromegaly)6.23NANot reportedNot reportedSingle participant analyzed
Sandostatin LAR 30mg (Acromegaly)24.111.6Not reportedNot reportedNot reported
Sandostatin LAR 20 mg (NET)27.8NANot reportedNot reportedSingle participant analyzed
Sandostatin LAR 30 mg (NET)39.920.5Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Single participant analyzed
        group Id
        OG000
        spread
        NA
        value
        6.23
      2. group Id
        OG001
        spread
        11.6
        value
        24.1
      3. comment
        Single participant analyzed
        group Id
        OG002
        spread
        NA
        value
        27.8
      4. group Id
        OG003
        spread
        20.5
        value
        39.9
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      1
    4. group Id
      OG003
      value
      4
    units
    Participants
description
Pharmacokinetics (PK) of octreotide after injection of Sandostatin Long-acting Release (LAR) was determined for the dosing period Day -28 to Day 0; AUC0-28d (day\*ng/mL). AUC0-28d: AUC from 0 to 28 days over the final dosing interval (day\*ng/mL) for Sandostatin LAR.
dispersion Type
Standard Deviation
groups
  1. description
    Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
    id
    OG000
    title
    Sandostatin LAR 10 mg (Acromegaly)
  2. description
    Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
    id
    OG001
    title
    Sandostatin LAR 30mg (Acromegaly)
  3. description
    Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
    id
    OG002
    title
    Sandostatin LAR 20 mg (NET)
  4. description
    Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
    id
    OG003
    title
    Sandostatin LAR 30 mg (NET)
param Type
MEAN
population Description
Pharmacokinetic population
reporting Status
POSTED
time Frame
Pre-dose; study Day -28- to Day 0 (PK analysis:Sandostatin (LAR®) sampling time points: 0, 1hour, 24hours, 7days, 14days, 21days and 28days)
title
Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) AUC
type
PRIMARY
unit Of Measure
day*ng/mL

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

Preserved source evidence · Not medical advice