Labor, InducedPhase 2NCT00259103
Recombinant Human Relaxin (rhRlx) in Pregnant Women Scheduled for Induction of Labor
A Phase 2 study testing Serelaxin in people with Labor, Induced, run by Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies at 3 sites in Russia.
Trial summary
The purpose of this study is to assess the safety and efficacy of rhRlx for cervical ripening, when compared to a placebo. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Labor, Induced
- What is being tested?
- Serelaxin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 3 sitesRussia
- Study dates
- Nov 2005to Oct 2006
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 40 years
- Normal pregnancy
- At least 40 weeks of gestation
- Otherwise healthy
Who cannot join
- Anemia or hypertension
- Presence of chronic disease
- Endometriosis
- Known fetal anomaly
- Substance abuse
- History of cancer
Trial locations and contacts
3 sites in 1 country.
Russia3 sites
Novosibirsk State Medical Academy
Novosibirsk
Evidence CPR
Saint Petersburg, 199034
D.O. Ott Research Institute of Obstetrics and Gynecology
Saint Petersburg
About this study
Official title: A Phase II Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Safety, Pharmacokinetics and Efficacy of Intravenous Recombinant Human Relaxin (rhRlx) in Pregnant Women Scheduled for Induction of Labour
The purpose of this study is to assess the safety and efficacy of rhRlx for cervical ripening, when compared to a placebo.
Read the detailed description
A multicenter, randomized, double-blind, placebo-controlled, dose escalation study of healthy female subjects at ≥ 40 weeks gestation and who are scheduled for induction. A dose-escalation portion of the study is followed by a randomized, double-blind, placebo-controlled portion of the study. The endpoints include cervical ripening, as well as progression to labor and delivery.
- Conditions
- Labor, Induced
- Being tested
- Serelaxin, Placebo
- Keywords
- relaxin, pregnancy, cervical ripening, normal pregnancy at least at 40 weeks of gestation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SerelaxinDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 7.5 µg/kg/d | Experimental | Participants who received intravenous (IV) infusion of 7.5 µg/kg/d serelaxin, all during part A. Receives: Drug: Serelaxin |
| 25 µg/kg/d | Experimental | Participants who received intravenous (IV) infusion of 25 µg/kg/d serelaxin, all during part A. Receives: Drug: Serelaxin |
| 75 µg/kg/d | Experimental | Participants who received IV infusion of 75 µg/kg/d serelaxin, some during part A and others during part B. Receives: Drug: Serelaxin |
| Placebo | Experimental | Participants who received IV infusion of placebo, some during part A and others during part B. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical ripening
Measured: Through 24 hours
Secondary outcomes (1)
Progression to active labor and delivery
Measured: Within 7 Days of Drug Infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2005 (estimated)
- Study startNov 2005
- Primary completionOct 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Labor, InducedStudies of the same condition, open and under way.
- 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sam Teichman, MD, Study director, Chief Medical Officer of BAS Medical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00259103
- Sponsor's protocol ID
- RLX.CR.001
- Status last verified
- May 2014
- First submitted
- 15 Nov 2005
- Last updated
- 7 May 2014
- Results posted
- No
Publications
Weiss G, Teichman S, Stewart D, Nader D, Wood S, Breining P, Unemori E. Recombinant human relaxin versus placebo for cervical ripening: a double-blind randomised trial in pregnant women scheduled for induction of labour. BMC Pregnancy Childbirth. 2016 Sep 5;16(1):260. doi: 10.1186/s12884-016-1046-1.
PubMed 27596360
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Safety, Pharmacokinetics and Efficacy of Intravenous Recombinant Human Relaxin (rhRlx) in Pregnant Women Scheduled for Induction of Labour
- ClinicalTrials.gov ID
- NCT00259103
- Acronym / sponsor ID
- RLX.CR.001
- Conditions
- Labor, Induced
- Keywords
- relaxin, pregnancy, cervical ripening, normal pregnancy at least at 40 weeks of gestation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companiesIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 29 Nov 2005 (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 purpose of this study is to assess the safety and efficacy of rhRlx for cervical ripening, when compared to a placebo.
Detailed description
A multicenter, randomized, double-blind, placebo-controlled, dose escalation study of healthy female subjects at ≥ 40 weeks gestation and who are scheduled for induction. A dose-escalation portion of the study is followed by a randomized, double-blind, placebo-controlled portion of the study. The endpoints include cervical ripening, as well as progression to labor and delivery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 7.5 µg/kg/d | Experimental | Drug: SerelaxinParticipants who received intravenous (IV) infusion of 7.5 µg/kg/d serelaxin, all during part A. |
| 25 µg/kg/d | Experimental | Drug: SerelaxinParticipants who received intravenous (IV) infusion of 25 µg/kg/d serelaxin, all during part A. |
| 75 µg/kg/d | Experimental | Drug: SerelaxinParticipants who received IV infusion of 75 µg/kg/d serelaxin, some during part A and others during part B. |
| Placebo | Experimental | Drug: PlaceboParticipants who received IV infusion of placebo, some during part A and others during part B. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 18 and 40 years
- Normal pregnancy
- At least 40 weeks of gestation
- Otherwise healthy
Key exclusion criteria (6 listed)
- Anemia or hypertension
- Presence of chronic disease
- Endometriosis
- Known fetal anomaly
- Substance abuse
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 |
|---|---|---|
| Serelaxin | Drug | 25 µg/kg/d, 7.5 µg/kg/d, 75 µg/kg/d |
| Placebo | Drug | Placebo |
Primary outcome
Cervical ripening
Time frame: Through 24 hours
1 secondary outcome
Progression to active labor and delivery
Time frame: Within 7 Days of Drug Infusion
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 7 May 2014.
- Derived from this study: PubMed 27596360Weiss G, Teichman S, Stewart D, Nader D, Wood S, Breining P, Unemori E. Recombinant human relaxin versus placebo for cervical ripening: a double-blind randomised trial in pregnant women scheduled for induction of labour. BMC Pregnancy Childbirth. 2016 Sep 5;16(1):260. doi: 10.1186/s12884-016-1046-1.
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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.
Sam Teichman, MD study director
Chief Medical Officer of BAS Medical, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Serelaxin in people with Labor, Induced, run by Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies at 3 sites in Russia.
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 4 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 7 May 2014. 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 Russia. 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?
Cervical ripening (time frame: Through 24 hours). 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 NCT00259103, which also lists 1 linked publication.
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 7 May 2014.