Efficacy and Safety Study of Ataciguat Versus Placebo in Patients With Neuropathic Pain

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00799656

Acronym

SERENEATI

Enrollment

Registered

2008-12-01

Start date

2008-11-30

Completion date

2009-09-30

Last updated

2011-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Diabetic neuropathy, painful pain, postoperative

Brief 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.

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.

Interventions

DRUGataciguat (HMR1766)

oral administration 200mg once daily for 28 days

DRUGplacebo

oral administration once daily for 28 days

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame
Change in average daily pain intensity	after 28-days treatment

Secondary

Measure	Time frame
Responder rate	after 28-days treatment
Rescue medication intake	during 28-days treatment
Change in Neuropathic Pain Symptom Inventory (NPSI)	after 28-days treatment

Countries

Austria, Czechia, Romania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026