NCT01208922

Brief Summary

The purpose of this study is to prove the non-inferiority of Rifamycin SV-MMX® versus Ciprofloxacin for the treatment of adults with traveller's diarrhoea.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
835

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2010

Longer than P75 for phase_3

Geographic Reach
3 countries

19 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

First Submitted

Initial submission to the registry

September 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 24, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

February 27, 2019

Completed
Last Updated

February 27, 2019

Status Verified

October 1, 2018

Enrollment Period

5.2 years

First QC Date

September 23, 2010

Results QC Date

February 8, 2018

Last Update Submit

October 16, 2018

Conditions

Traveler's Diarrhea

Outcome Measures

Primary Outcomes (1)

  • Time to Last Unformed Stool (TLUS)

    Time to Last Unformed Stool (TLUS), defined as the interval in hours between the first dose of study drug and the last unformed stool passed, after which clinical cure was declared.

    5 days

Secondary Outcomes (1)

  • Number of Patients With Clinical Cure

    5 days

Study Arms (2)

Group A

EXPERIMENTAL

Rifamycin SV-MMX® 200 mg tablets

Drug: Rifamycin SV-MMX®

Group B

ACTIVE COMPARATOR

Ciprofloxacin 500 mg capsules

Drug: Ciprofloxacin

Interventions

Rifamycin SV-MMX®DRUG

2 Rifamycin SV-MMX® 200 mg tablets and 1 placebo to ciprofloxacin capsule, b.i.d.

Group A
CiprofloxacinDRUG

1 ciprofloxacin 500 mg capsule and 2 placebos to Rifamycin SV-MMX® 200 mg tablets, b.i.d.

Group B

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent,
  • Men or women between 18 and 85 years of age,
  • History of arriving from their country of residence in the industrialized part of the world within the past 4 weeks,
  • Presenting with acute infectious diarrhoea (defined as at least 3 unformed, watery or soft stools accompanied by symptoms within 24 hours preceding randomisation with duration of illness ≤ 72 hours),
  • Presence of one or more signs or symptoms of enteric infection (moderate to severe gas/flatulence, nausea, vomiting, abdominal cramps or pain, rectal tenesmus, fecal urgency),
  • Women of childbearing potential had to apply during the entire duration of the study a highly effective method of birth control

You may not qualify if:

  • Residency in any country with high incidence rate of TD within the past 6 months,
  • Fever (defined as a body (oral) temperature \>100.4°F or 38.0°C; antipyretic medication should not have been administered in the 6 hours prior to this assessment),
  • Known or suspected infection with non-bacterial pathogen,
  • Presence of diarrhoea of \>72 hours duration,
  • Presence of grossly bloody stool,
  • Presence of moderate or severe dehydration (i.e. symptoms of hypovolemia such as orthostatic hypotension, dizziness or wrinkling of skin),
  • History of inflammatory bowel disease or celiac disease,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Site 401

Quito, Ecuador

Location

Site 200

Quetzaltenango, Guatemala

Location

Site 101

Mapusa, Karaswada, India

Location

Site 124

Ajmer, India

Location

Site 118

Bardez, India

Location

Site 120

Calangute, India

Location

Site 104

Hyderabad, India

Location

Site 114

Kolkata, India

Location

Site 116

Lucknow, India

Location

Site 107

Madgaon, India

Location

Site 110

Madgaon, India

Location

Site 123

New Delhi, India

Location

Site 122

Panjim, India

Location

Site 102

Puducherry, India

Location

Site 115

Pushkar, India

Location

Site 119

Salcette, India

Location

Site 111

Tiswadi, India

Location

Site 109

Varanasi, India

Location

Site 103

Vijayawada, India

Location

MeSH Terms

Interventions

Ciprofloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Department of Clinical Research
Organization
Dr. Falk Pharma GmbH
zentrale@drfalkpharma.de
0049 7611514

Study Officials

  • Professor Robert Steffen, M. D.

    University of Zurich, Switzerland

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
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

September 23, 2010

First Posted

September 24, 2010

Study Start

November 1, 2010

Primary Completion

January 1, 2016

Study Completion

May 1, 2016

Last Updated

February 27, 2019

Results First Posted

February 27, 2019

Record last verified: 2018-10

Locations

GU(1)IN(17)EC(1)