PainPhase 2SERENEATINCT00799656
Efficacy and Safety Study of Ataciguat Versus Placebo in Patients With Neuropathic Pain
A Phase 2 study testing ataciguat (HMR1766) in people with Pain, run by Sanofi at 3 sites in 3 countries.
Trial summary
The primary objective of this study is to assess the efficacy of ataciguat versus placebo in reducing pain intensity in patients with neuropathic pain. The secondary objective is to assess the safety and tolerability of ataciguat versus placebo. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain
- What is being tested?
- ataciguat (HMR1766)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Nov 2008to Sep 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic neuropathic pain due to diabetic polyneuropathy or a nerve lesion following surgery. The pain must be present for more than 3 months.
Who cannot join
- Presence or history of cancer within the past five years
- Patients with a history of HIV infection
- Patients with active hepatitis B or C
- Patients with any pain other than the neuropathic pain of greater or equal severity
- Patients with a diabetes mellitus for less than 6 months
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Efficacy and Safety of Oral Ataciguat (HMR1766) 200 mg Administered Once Daily for 28 Days on Pain Reduction in Patients With Neuropathic Pain. A Randomized, Double-blind, Placebo-controlled, Cross-over Study
The primary objective of this study is to assess the efficacy of ataciguat versus placebo in reducing pain intensity in patients with neuropathic pain.
The secondary objective is to assess the safety and tolerability of ataciguat versus placebo.
Read the detailed description
This study consists of two consecutive 28 day treatment periods which are separated by a 2 week medication free period and a safety follow-up period of 2 weeks after the second treatment period.
- Conditions
- Pain
- Being tested
- ataciguat (HMR1766), placebo
- Keywords
- Diabetic neuropathy, painful pain, postoperative
- Medical subject headings
- Pain, Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ataciguat (HMR1766)Drug
oral administration 200mg once daily for 28 days
placeboDrug
oral administration once daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | First period: Ataciguat - Second period: Placebo Receives: Drug: ataciguat (HMR1766); Drug: placebo |
| 2 | Experimental | First period: Placebo - Second period: Ataciguat Receives: Drug: ataciguat (HMR1766); Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in average daily pain intensity
Measured: after 28-days treatment
Secondary outcomes (3)
Responder rate
Measured: after 28-days treatment
Rescue medication intake
Measured: during 28-days treatment
Change in Neuropathic Pain Symptom Inventory (NPSI)
Measured: after 28-days treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionJun 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Hans-Goerg Kress, Professor, Principal investigator, Medizinische Universität / AKH Wien - Währinger Gürtel 18-20 - A-1090 Wien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00799656
- Sponsor's protocol ID
- DFI10569
- Other IDs
- EudraCT 2008-001518-26
- Acronym
- SERENEATI
- Status last verified
- Mar 2011
- First submitted
- 27 Nov 2008
- Last updated
- 1 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Oral Ataciguat (HMR1766) 200 mg Administered Once Daily for 28 Days on Pain Reduction in Patients With Neuropathic Pain. A Randomized, Double-blind, Placebo-controlled, Cross-over Study
- ClinicalTrials.gov ID
- NCT00799656
- Acronym / sponsor ID
- SERENEATI / DFI10569
- Conditions
- Pain
- Keywords
- Diabetic neuropathy, painful pain, postoperative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 1 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to assess the efficacy of ataciguat versus placebo in reducing pain intensity in patients with neuropathic pain.
The secondary objective is to assess the safety and tolerability of ataciguat versus placebo.
Detailed description
This study consists of two consecutive 28 day treatment periods which are separated by a 2 week medication free period and a safety follow-up period of 2 weeks after the second treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ataciguat (HMR1766), Drug: placeboFirst period: Ataciguat - Second period: Placebo |
| 2 | Experimental | Drug: ataciguat (HMR1766), Drug: placeboFirst period: Placebo - Second period: Ataciguat |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with chronic neuropathic pain due to diabetic polyneuropathy or a nerve lesion following surgery. The pain must be present for more than 3 months.
Key exclusion criteria (6 listed)
- Presence or history of cancer within the past five years
- Patients with a history of HIV infection
- Patients with active hepatitis B or C
- Patients with any pain other than the neuropathic pain of greater or equal severity
- Patients with a diabetes mellitus for less than 6 months
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 |
|---|---|---|
| ataciguat (HMR1766)oral administration 200mg once daily for 28 days | Drug | 1, 2 |
| placebooral administration once daily for 28 days | Drug | 1, 2 |
Primary outcome
Change in average daily pain intensity
Time frame: after 28-days treatment
3 secondary outcomes
Responder rate
Time frame: after 28-days treatment
Rescue medication intake
Time frame: during 28-days treatment
Change in Neuropathic Pain Symptom Inventory (NPSI)
Time frame: after 28-days treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2011.
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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.
Hans-Goerg Kress, Professor principal investigator
Medizinische Universität / AKH Wien - Währinger Gürtel 18-20 - A-1090 Wien
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ataciguat (HMR1766) in people with Pain, run by Sanofi at 3 sites in 3 countries.
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 6 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 1 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Austria, Czechia, Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in average daily pain intensity (time frame: after 28-days treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2011.