Hepatitis CPhase 2NCT00704184

Safety and Efficacy of Vaniprevir (MK7009) Administered With Pegylated-Interferon and Ribavirin (MK-7009-007)

A Phase 2 study testing Comparator: Vaniprevir, Comparator: Pegylated-Interferon (Peg-IFN) and Comparator: Ribavirin in people with Hepatitis C, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Hepatitis C
What is being tested?: Comparator: Vaniprevir, Comparator: Pegylated-Interferon (Peg-IFN) and Comparator: Ribavirin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 95 participants
Where: No sites listed yet
Study dates: 25 Jul 2008to 14 Apr 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient has chronic Genotype 1 Hepatitis C infection

Who cannot join

Subject has been previously treated for HCV
Has Human Immunodeficiency Virus (HIV)
Has Hepatitis B
Has a history of clinically significant medical condition that may interfere with the study (e.g., stroke or chronic seizures or major neurological disorder) or is contraindicated for treatment with peg-IFN and Ribavirin

About this study

Official title: A Phase II, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of MK7009 Administered Concomitantly With Pegylated-Interferon and Ribavirin for 28 Days in Treatment-Naive Patients With Chronic Hepatitis C Infection

A study to evaluate how effective different levels of Vaniprevir (MK-7009), when administered with Pegylated-Interferon (Peg-IFN) and Ribavirin, are at achieving rapid viral response (RVR) i.e., undetectable hepatitis C virus [HCV] viral ribonucleic acid [RNA] at Week 4 in participants with chronic HCV infection. The primary hypothesis was that the proportion of participants in one or more of the Vaniprevir treatment groups achieving RVR would be greater than the proportion of placebo participants achieving RVR when Vaniprevir and placebo were co-administered with Peg-IFN/Ribavirin.

Conditions: Hepatitis C
Being tested: Comparator: Vaniprevir, Comparator: Pegylated-Interferon (Peg-IFN), Comparator: Ribavirin, Comparator: placebo
Medical subject headings: Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Comparator: VaniprevirDrug
Also called MK-7009
Vaniprevir 300 mg b.i.d., 600 mg b.i.d., 600 mg q.d., or 800 mg q.d.; duration of treatment: 28 days
Comparator: Pegylated-Interferon (Peg-IFN)Drug
Peg-IFN 180 mcg once-weekly subcutaneous injection; duration of treatment: 48 weeks
Comparator: RibavirinDrug
Ribavirin 200 mg tablet b.i.d. (dose based on body weight); duration of treatment: 48 weeks
Comparator: placeboDrug
Matching placebo to vaniprevir; duration of treatment: 28 days

Study groups in NCT00704184
Study group	Role	What they receive
Placebo + Peg-IFN/Ribavirin	Placebo comparator	Participants took double-blind Placebo + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48. Receives: Drug: Comparator: Pegylated-Interferon (Peg-IFN); Drug: Comparator: Ribavirin
Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin	Experimental	Participants took double-blind Vaniprevir 300 mg twice daily (b.i.d.) + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48. Receives: Drug: Comparator: Vaniprevir; Drug: Comparator: Pegylated-Interferon (Peg-IFN); Drug: Comparator: Ribavirin
Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin	Experimental	Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48. Receives: Drug: Comparator: Vaniprevir; Drug: Comparator: Pegylated-Interferon (Peg-IFN); Drug: Comparator: Ribavirin
Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin	Experimental	Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48. Receives: Drug: Comparator: Vaniprevir; Drug: Comparator: Pegylated-Interferon (Peg-IFN); Drug: Comparator: Ribavirin
Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin	Experimental	Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48. Receives: Drug: Comparator: Vaniprevir; Drug: Comparator: Pegylated-Interferon (Peg-IFN); Drug: Comparator: Ribavirin; Drug: Comparator: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants Achieving RVR
Rapid Viral Response (RVR) was declared if Hepatitis C Virus (HCV) ribonucleic acid (RNA) was undetectable at Week 4.
Measured: Week 4
Number of Participants Experiencing an Adverse Event (AE)
The number of participants experiencing AEs in each treatment group was monitored during the Vaniprevir/Placebo treatment (Day 1 to Day 28) and safety follow-up (Day 29 to Day 42) periods.
Measured: Up to Day 42
Number of Participants Discontinuing From Study Therapy Due to AEs
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study therapy, whether or not considered related to the use of the product.
Measured: Day 1 to Day 28

Secondary outcomes (3)

Number of Participants With ≥2-log10 Decrease in HCV RNA
The number of participants with at least a 2-log10 decrease from baseline in HCV RNA following 4 weeks of treatment with Placebo or Vaniprevir.
Measured: Baseline and Week 4
Number of Participants With ≥3-log10 Decrease in HCV RNA
The number of participants with at least a 3-log10 decrease from baseline in HCV RNA following 4 weeks of treatment with Placebo or Vaniprevir.
Measured: Baseline and Week 4
Mean Log Change From Baseline in HCV RNA
The mean changes from baseline in log10 HCV RNA in each vaniprevir group was compared against control treatment at Week 4.
Measured: Baseline and Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Jul 200814 Apr 2010

First posted24 Jun 2008 (estimated)
Study start25 Jul 2008
Primary completion12 Dec 2008
Study completion14 Apr 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Hepatitis CStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 95 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00704184
Sponsor's protocol ID: 7009-007
Other IDs: MK7009-007, 2007_658
Status last verified: Sep 2018
First submitted: 23 Jun 2008
Last updated: 9 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

Manns MP, Gane E, Rodriguez-Torres M, Stoehr A, Yeh CT, Marcellin P, Wiedmann RT, Hwang PM, Caro L, Barnard RJ, Lee AW; MK-7009 Protocol 007 Study Group. Vaniprevir with pegylated interferon alpha-2a and ribavirin in treatment-naive patients with chronic hepatitis C: a randomized phase II study. Hepatology. 2012 Sep;56(3):884-93. doi: 10.1002/hep.25743. Epub 2012 Jul 17.
PubMed 22473713
Lawitz E, Sulkowski M, Jacobson I, Kraft WK, Maliakkal B, Al-Ibrahim M, Gordon SC, Kwo P, Rockstroh JK, Panorchan P, Miller M, Caro L, Barnard R, Hwang PM, Gress J, Quirk E, Mobashery N. Characterization of vaniprevir, a hepatitis C virus NS3/4A protease inhibitor, in patients with HCV genotype 1 infection: safety, antiviral activity, resistance, and pharmacokinetics. Antiviral Res. 2013 Sep;99(3):214-20. doi: 10.1016/j.antiviral.2013.05.015. Epub 2013 Jun 7.
PubMed 23747481

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
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All Hepatitis C trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of MK7009 Administered Concomitantly With Pegylated-Interferon and Ribavirin for 28 Days in Treatment-Naive Patients With Chronic Hepatitis C Infection
ClinicalTrials.gov ID: NCT00704184
Acronym / sponsor ID: 7009-007
Conditions: Hepatitis C
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 95 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 25 Jul 2008 (actual)
Primary completion: 12 Dec 2008 (actual)
Study completion: 14 Apr 2010 (actual)
First posted: 24 Jun 2008 (estimated)
Results: Posted 1 Oct 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
Placebo + Peg-IFN/Ribavirin	Placebo comparator	Drug: Comparator: Pegylated-Interferon (Peg-IFN), Drug: Comparator: RibavirinParticipants took double-blind Placebo + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.
Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin	Experimental	Drug: Comparator: Vaniprevir, Drug: Comparator: Pegylated-Interferon (Peg-IFN), Drug: Comparator: RibavirinParticipants took double-blind Vaniprevir 300 mg twice daily (b.i.d.) + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.
Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin	Experimental	Drug: Comparator: Vaniprevir, Drug: Comparator: Pegylated-Interferon (Peg-IFN), Drug: Comparator: RibavirinParticipants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.
Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin	Experimental	Drug: Comparator: Vaniprevir, Drug: Comparator: Pegylated-Interferon (Peg-IFN), Drug: Comparator: RibavirinParticipants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.
Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin	Experimental	Drug: Comparator: Vaniprevir, Drug: Comparator: Pegylated-Interferon (Peg-IFN), Drug: Comparator: Ribavirin, Drug: Comparator: placeboParticipants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavirin from Week 5 to Week 48.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patient has chronic Genotype 1 Hepatitis C infection

Key exclusion criteria (4 listed)

Subject has been previously treated for HCV
Has Human Immunodeficiency Virus (HIV)
Has Hepatitis B
Has a history of clinically significant medical condition that may interfere with the study (e.g., stroke or chronic seizures or major neurological disorder) or is contraindicated for treatment with peg-IFN and Ribavirin

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Comparator: VaniprevirAlso: MK-7009Vaniprevir 300 mg b.i.d., 600 mg b.i.d., 600 mg q.d., or 800 mg q.d.; duration of treatment: 28 days	Drug	Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin, Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin, Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin, Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin
Comparator: Pegylated-Interferon (Peg-IFN)Peg-IFN 180 mcg once-weekly subcutaneous injection; duration of treatment: 48 weeks	Drug	Placebo + Peg-IFN/Ribavirin, Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin, Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin, Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin, Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin
Comparator: RibavirinRibavirin 200 mg tablet b.i.d. (dose based on body weight); duration of treatment: 48 weeks	Drug	Placebo + Peg-IFN/Ribavirin, Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin, Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin, Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin, Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin
Comparator: placeboMatching placebo to vaniprevir; duration of treatment: 28 days	Drug	Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin

Primary outcome

Percentage of Participants Achieving RVR
Time frame: Week 4
Rapid Viral Response (RVR) was declared if Hepatitis C Virus (HCV) ribonucleic acid (RNA) was undetectable at Week 4.
Number of Participants Experiencing an Adverse Event (AE)
Time frame: Up to Day 42
The number of participants experiencing AEs in each treatment group was monitored during the Vaniprevir/Placebo treatment (Day 1 to Day 28) and safety follow-up (Day 29 to Day 42) periods.
Number of Participants Discontinuing From Study Therapy Due to AEs
Time frame: Day 1 to Day 28
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study therapy, whether or not considered related to the use of the product.

3 secondary outcomes

Number of Participants With ≥2-log10 Decrease in HCV RNA
Time frame: Baseline and Week 4
Number of Participants With ≥3-log10 Decrease in HCV RNA
Time frame: Baseline and Week 4
Mean Log Change From Baseline in HCV RNA
Time frame: Baseline and Week 4

Results and safety

Results posted to the registry on 1 Oct 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo + Peg-IFN/Ribavirin	20	19
Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin	18	18
Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin	20	20
Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin	18	18
Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin	19	19

Primary outcome: Percentage of Participants Achieving RVR

Time frame: Week 4. Number. Unit: Percentage of Participants

Measure	Placebo + Peg-IFN/Ribavirin n = 18	Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin n = 16	Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin n = 19	Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin n = 16	Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin n = 18
Value	5.6	75.0	78.9	68.8	83.3

Placebo + Peg-IFN/Ribavirin vs Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin: Adjusted difference in %: 69.3 (95% CI 40.3 to 86.7), p <0.001, Miettinen and Nurminen method
Placebo + Peg-IFN/Ribavirin vs Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin: Adjusted difference in %: 73.6 (95% CI 46.0 to 88.6), p <0.001, Miettinen and Nurminen method
Placebo + Peg-IFN/Ribavirin vs Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin: Adjusted difference in %: 63.3 (95% CI 32.8 to 82.7), p <0.001, Miettinen and Nurminen method

Population analysed: The Per Protocol population included all participants who did not have clinically important deviations from protocol-specified criteria. Only participants with an HCV RNA result at the Week 4 time point were included in the analysis.

Primary outcome: Number of Participants Experiencing an Adverse Event (AE)

Time frame: Up to Day 42. Number. Unit: Participants

Measure	Placebo + Peg-IFN/Ribavirin n = 19	Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin n = 18	Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin n = 20	Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin n = 18	Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin n = 19
Value	18	15	18	16	18

Population analysed: The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.

Primary outcome: Number of Participants Discontinuing From Study Therapy Due to AEs

Time frame: Day 1 to Day 28. Number. Unit: Participants

Measure	Placebo + Peg-IFN/Ribavirin n = 19	Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin n = 18	Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin n = 20	Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin n = 18	Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin n = 19
Value	0	0	0	0	0

Population analysed: The Safety Population consists of all randomized participants who received at least 1 dose of study therapy

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo + Peg-IFN/Ribavirin	1 of 19 (5.3%)	19 of 19 (100%)	Not reported
Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin	3 of 18 (16.7%)	16 of 18 (88.9%)	Not reported
Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin	1 of 20 (5%)	20 of 20 (100%)	Not reported
Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin	2 of 18 (11.1%)	17 of 18 (94.4%)	Not reported
Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin	2 of 19 (10.5%)	18 of 19 (94.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22473713Manns MP, Gane E, Rodriguez-Torres M, Stoehr A, Yeh CT, Marcellin P, Wiedmann RT, Hwang PM, Caro L, Barnard RJ, Lee AW; MK-7009 Protocol 007 Study Group. Vaniprevir with pegylated interferon alpha-2a and ribavirin in treatment-naive patients with chronic hepatitis C: a randomized phase II study. Hepatology. 2012 Sep;56(3):884-93. doi: 10.1002/hep.25743. Epub 2012 Jul 17.
Derived from this study: PubMed 23747481Lawitz E, Sulkowski M, Jacobson I, Kraft WK, Maliakkal B, Al-Ibrahim M, Gordon SC, Kwo P, Rockstroh JK, Panorchan P, Miller M, Caro L, Barnard R, Hwang PM, Gress J, Quirk E, Mobashery N. Characterization of vaniprevir, a hepatitis C virus NS3/4A protease inhibitor, in patients with HCV genotype 1 infection: safety, antiviral activity, resistance, and pharmacokinetics. Antiviral Res. 2013 Sep;99(3):214-20. doi: 10.1016/j.antiviral.2013.05.015. Epub 2013 Jun 7.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Comparator: Vaniprevir, Comparator: Pegylated-Interferon (Peg-IFN) and Comparator: Ribavirin in people with Hepatitis C, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving RVR (time frame: Week 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00704184, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2018.