NCT02078856

Brief Summary

The purpose of this trial is to determine the efficacy and safety of A3384 administered to patients with Bile Acid Malabsorption (BAM)/Bile Acid Diarrhoea (BAD).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2014

Shorter than P25 for phase_2

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 5, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 7, 2024

Status Verified

March 1, 2024

Enrollment Period

9 months

First QC Date

March 3, 2014

Last Update Submit

March 6, 2024

Conditions

Bile Acid Malabsorption

Outcome Measures

Primary Outcomes (1)

  • The primary efficacy objective of this study is to demonstrate the efficacy of different daily doses of A3384 as determined by the # of bowel movements (BMs).

    2 weeks

Secondary Outcomes (1)

  • Secondary efficacy objectives of this study are to demonstrate the efficacy of different daily doses on other BM parameters and BAM/BAD symptoms

    Baseline and 2 weeks

Study Arms (3)

A3384 Low dose

EXPERIMENTAL

Administered twice daily for the duration of the study

Drug: A3384

A3384 High dose

EXPERIMENTAL

Administered twice daily for the duration of the study

Drug: A3384

Placebo

PLACEBO COMPARATOR

Administered twice daily for the duration of the study

Drug: A3384

Interventions

A3384DRUG
A3384 High doseA3384 Low dosePlacebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient meets protocol specified criteria for Bile Acid Malabsorption/Bile Acid Diarrhoea
  • Patient has successfully completed study requirements with no clinically relevant findings for physical exam, ECG, laboratory tests as applicable

You may not qualify if:

  • Medical history or medical condition that would not make the patient a good candidate for the study or limit the patient´s ability to complete the study
  • Patient needs medications prohibited as specified in the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Sahlgrenska Academy

Gothenburg, Sweden

Location

Kärnsjukhuset

Skövde, Sweden

Location

Hammersmith Hospital, Imperial College Healthcare NHS Trust

London, W12 0HS, United Kingdom

Location

Study Officials

  • Ipsen Medical Director

    Ipsen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2014

First Posted

March 5, 2014

Study Start

March 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

March 7, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

Time Frame
Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
Access Criteria
Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
More information

Locations

SE(2)GB(1)