AdhesionPhase 2NCT03660787
Efficacy and Dose Ranging Study of Seroguard
A Phase 2 study testing Seroguard in people with Adhesion, run by Pharmasyntez at 14 sites in Russia.
Trial summary
This trial was a multi-center, double-blind, randomized, parallel group, placebo-controlled, phase II study in adult hospitalized female patients with the confirmed diagnosis of pelvic adhesive disease in Study centres in Russia. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Adhesion
- What is being tested?
- Seroguard
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 14 sitesRussia
- Study dates
- 4 May 2017to 23 Jan 2018
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients aged from 18 to 45 years with the confirmed diagnosis of pelvic adhesions having indications for surgery (laparoscopic adhesiolysis).
- Voluntarily and personally signed and dated Form of Informed Consent.
- Female patients with pelvic adhesions confirmed by gynecological and ultrasound examination.
Who cannot join
- Female patients having contraindications to surgical treatment (including acute or exacerbated chronical adnexal inflammation);
- Body mass index of 30.0 kg/m2 and more;
- Known hypersensitivity to the test drug components (Seroguard);
- Pregnancy, breastfeeding or planning a pregnancy during the clinical trial;
- Refusal to use effective contraception methods throughout the study;
- Positive HIV, RW, HBV or HCV test result;
Show all 32Show fewer
- Alcohol abuse, drug addiction, and toxicomania (except smoking);
- American Society of Anesthesiologists physical status category III and more (ASA);
- Purulent process in the abdominal cavity;
- Disseminated endometriosis;
- WBC count more than 10*109/L at the complete blood count;
- Need of using any drugs during the surgery other than 0.02% chlorhexidine aqueous solution throughout the surgery, as well as the test drug or the placebo (0.9% sodium chloride) administered intraperitoneally in the end of surgery.
- Concomitant diseases that may require conversion of the surgical intervention by other indications;
- Type I or II diabetes mellitus;
- Deep vein thrombosis and/or PATE at the screening or in the medical history;
- Renal impairment (glomerular filtration rate less than 60 mL/min/1.73 m2 assessed by the CKD-EPI equation);
- Liver disorders defined as more than 2-fold rise of the upper limit of normal of one of the following enzymes: ALT, AST, GGTP, AP, or more than 2-fold total bilirubin increase;
- Myocardial infarction within 6 months before screening;
- Any concomitant diseases accompanied by heart failure;
- Clinically significant ECG changes (as to the investigator's opinion);
- Any concomitant diseases accompanied by respiratory failure;
- Any oncological disease within 3 years before enrollment into the study;
- Systemic inflammatory diseases;
- Diseases associated with chronic hemorrhages;
- Blood diseases (anemias of any origin, hemoglobinopathies, inherited and acquired coagulopathies, hemostasis disorders, thrombocytopenias, and thrombocytopathias, any hemoblastoses);
- Any other disease that, in the investigator's opinion, may affect study results or present an additional threat to well-being of a patient after administration of the study drug;
- Use of anticoagulants, antiaggregants (except for acetylsalicylic acid at the dose of less than 325 mg/day) at the moment of inclusion into the study or planning to do so during the study;
- Use of drugs with pronounced hemato-, hepato-, or nephrotoxic action, drugs of biological origin;
- Need to administer cytostatics, systemic glucocorticosteroids, and other immunosuppressive agents during the patient's participation in the study.
- Participation in any other clinical trial within 30 days before screening;
- Contraindications to MRI (presence of implants or implanted electronic devices);
- Impossibility or inability to comply with the requirements of the protocol, including for physical, psychic or social reasons, in the investigator's opinion.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Russia14 sites
State Funded Health Care Institution "Bryansk Municipal Hospital No 1
Bryansk, The Bryansk Region, 241035
State Educational Government-Financed Institution of Higher Professional Education "Kazan State Medical University" of the Ministry of Health of the Russian at the clinical site of Kazan Maternity Hospital No. 3 named after V.S. Gruzdev
Kazan', Tatarstan Republic, 420012
Federal State Educational Government-Financed Institution of Higher Education "Kemerovo State Medical University" of the Ministry of Healthcare of the Russian Federation at the clinical site of Kemerovo Oblast Publicly Funded Healthcare Institution "L.A.
Kemerovo, The Kemerovo Region, 650000
Krai Government-Owned State Funded Healthcare Institution "Krai Clinical Hospital"
Krasnoyarsk, Krasnoyarsk Krai, 660022
State Educational Government-Financed Institution of Higher Professional Education "Krasnoyarsk State Medical University named after Prof. V.F. Voino-Yasenetsky" of the Ministry of Healthcare of the Russian Federation at the clinical site Publicly Funded
Krasnoyarsk, Krasnoyarsk Krai, 660074
State Funded Healthcare Institution of Moscow of City Health Department "V.M. Buyanov Municipal Clinical Hospital"
Moscow, Moscow Oblast, 115516
Federal State Institution "V.I. Kulakov Research Center for Obstetrics, Gynecology, and Perinatology" of the Ministry of Healthcare and Social Development of the Russian Federation.
Moscow, Moscow Oblast, 117997
Moscow Oblast State Funded Healthcare Institution "Moscow Oblast Research Institute of Obstetrics and Gynecology"
Moscow, The Moscow Region, 101000
State Funded Healthcare Institution of Moscow of City Health Department "Moscow Municipal Clinical Hospital No 31"
Moscow, The Moscow Region, 119415
State Educational Government-Financed Institution of Higher Professional Education "Rostov State Medical University" of the Ministry of Healthcare of the Russian Federation at the clinical site of Obstetrics and Pediatrics Research Institute
Rostov-on-Don, The Rostov Region, 344013
Federal State Educational Government-Financed Institution of Higher Education "I.P. Pavlov Ryazan State Medical University" of the Ministry of Healthcare of the Russian Federation at the clinical site of State Funded Healthcare Institution "Municipal Clin
Ryazan, The Ryazan Region
Federal State Funded Healthcare Institution "L.G. Sokolov Federal Biomedical Agency Clinical Hospital No 122".
Saint Petersburg, The Leningrad Region, 194291
Federal State Funded Scientific Institution "Research Institute of Obstetrics, Gynecology and Reproductology named after D.O. Ott" of the Ministry of Healthcare of the Russian Federation
Saint Petersburg, The Leningrad Region, 199034
Federal State Funded Healthcare Institution "Ural Research Institute of Maternal and Infant Care" of the Ministry of Healthcare of the Russian Federation
Yekaterinburg, The Sverdlovsk Region, 620028
About this study
Official title: Phase II Multi-center Randomized Double-blind Placebo-controlled Efficacy and Dose Ranging Trial of the Drug Product Seroguard, Solution (JSC Pharmasyntez, Russia) Used for the Prevention of Pelvic Adhesions
This trial was a multi-center, double-blind, randomized, parallel group, placebo-controlled, phase II study in adult hospitalized female patients with the confirmed diagnosis of pelvic adhesive disease in Study centres in Russia.
Read the detailed description
In order to evaluate efficacy and safety of Seroguard, solution for IP administration, a study design meeting the set objectives was selected: prospective, multi-center, double-blind, randomized, parallel group, placebo-controlled study.
Given the fact that comparison with placebo is considered the best way to prove efficacy and safety of a drug and that currently there are no drugs with a similar mechanism of action at the pharmaceutical product market, a placebo-controlled, parallel group study design was selected.
A randomized, parallel group study design was chosen in order to ensure minimization of a selection bias.
Subjects were randomized into four groups (two groups of the test drug and two placebo groups corresponding to the two doses) to enable a comparison of Seroguard administration at two doses.
A double-blind study design was selected in order to ensure minimization of an outcome evaluation bias.
- Conditions
- Adhesion
- Being tested
- Seroguard, Placebo
- Keywords
- Adhesion, Efficacy
- Medical subject headings
- Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeroguardDrug
Seroguard 0.41 g/L solution
PlaceboDrug
Saline
| Study group | Role | What they receive |
|---|---|---|
| Placebo, 1.5 mL/kg | Placebo comparator | each subject received the placebo at the dose of 1.5 mL/kg of body weight; Receives: Drug: Placebo |
| Placebo, 2.4 mL/kg | Placebo comparator | each subject received the placebo at the dose of 2.4 mL/kg of body weight; Receives: Drug: Placebo |
| Seroguard, 1.5 mL/kg | Experimental | each subject received the test drug at the dose of 1.5 mL/kg of body weight; Receives: Drug: Seroguard |
| Seroguard, 2.4 mL/kg | Experimental | each subject received the test drug at the dose of 2.4 mL/kg of body weight. Receives: Drug: Seroguard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Reduction of Adhesions Number by 3 or More
The number of adhesions according to the first MRI data was compared to the number according to the data of second MRI
Measured: 30±4 days after surgical intervention
Secondary outcomes (6)
Change in Thickness of Pelvic Adhesions
The change from baseline was defined. It was evaluated by comparing baseline MRI data and repeated MRI data. Results were estimated according to scale from 0 to 3 where 0 - no adhesions, 1 - thin (filmy or filiform), 2 - marked, 3 - marked with an impaired passage through organs involved.
Measured: 30±4 days after surgery
Number of Participants With Detection of Pelvic Organs Limited Mobility
The frequency was estimated based on transvaginal ultrasound results
Measured: 30±4 days after surgery
Number of Participants With Detection of Hyperechoic Linear Lesions Post Surgery
The frequency was estimated based on transvaginal ultrasound results
Measured: 30±4 days after surgery
Change in Number of Participants in Detecting Pelvic Organs Limited Mobility
Absolute change of count of participants was measured with detecting pelvic organs limited mobility from the baseline
Measured: 30±4 days after surgery
Change Number of Participants in Detecting Hyperechoic Linear Lesions
Frequency of detecting after repeated transvaginal ultrasound results was compared to baseline indications (4 or more)
Measured: 30±4 days after surgery
Number of Participants With Detection of no Ultrasound Signs of Pelvic Adhesive Disease Post Surgery
No limited mobility of pelvic organs and no hyperechoic linear lesions should be shown
Measured: 30±4 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start4 May 2017
- Primary completion23 Jan 2018
- Study completion23 Jan 2018
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 (35)Papers the sponsor has linked to this study.
- Other trials for AdhesionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmasyntez
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cromos Pharma LLC
- Responsible party
- Sponsor
- Investigators
- Mikhail Shurygin, PhD,D.M.Sc., Study chair, Pharmasyntez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03660787
- Sponsor's protocol ID
- SG-2/1215
- Status last verified
- Jun 2019
- First submitted
- 31 Aug 2018
- Last updated
- 19 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Miller JH, Weinberg RK, Canino NL, Klein NA, Soules MR. The pattern of infertility diagnoses in women of advanced reproductive age. Am J Obstet Gynecol. 1999 Oct;181(4):952-7. doi: 10.1016/s0002-9378(99)70331-5.
PubMed 10521760Dun EC, Nezhat CH. Tubal factor infertility: diagnosis and management in the era of assisted reproductive technology. Obstet Gynecol Clin North Am. 2012 Dec;39(4):551-66. doi: 10.1016/j.ogc.2012.09.006.
PubMed 23182560Westrom L. Effect of acute pelvic inflammatory disease on fertility. Am J Obstet Gynecol. 1975 Mar 1;121(5):707-13. doi: 10.1016/0002-9378(75)90477-9.
PubMed 123123Westrom LV. Sexually transmitted diseases and infertility. Sex Transm Dis. 1994 Mar-Apr;21(2 Suppl):S32-7.
PubMed 8042113Patil M. Assessing tubal damage. J Hum Reprod Sci. 2009 Jan;2(1):2-11. doi: 10.4103/0974-1208.51335.
PubMed 19562067Sutherland AM. The changing pattern of tuberculosis of the female genital tract. A thirty year survey. Arch Gynecol. 1983;234(2):95-101. doi: 10.1007/BF00207681.
PubMed 6667046Mueller BA, Daling JR, Moore DE, Weiss NS, Spadoni LR, Stadel BV, Soules MR. Appendectomy and the risk of tubal infertility. N Engl J Med. 1986 Dec 11;315(24):1506-8. doi: 10.1056/NEJM198612113152402.
PubMed 3785307Schwartz L, Diamond M. Formation, Reduction, and Treatment of Adhesive Disease. Seminars in Reproductive Medicine. 1991; 9(02): p. 89-99.
Vaid K, Mehra S, Verma M, Jain S, Sharma A, Bhaskaran S. Pan endoscopic approach "hysterolaparoscopy" as an initial procedure in selected infertile women. J Clin Diagn Res. 2014 Feb;8(2):95-8. doi: 10.7860/JCDR/2014/7271.4018. Epub 2014 Feb 3.
PubMed 24701493Neerja, Jain K. Role of laporoscopy-hysteroscopy in cases of infertility with pregnancy outcome. J Indian Med Assoc. 2014 Feb;112(2):85-6, 88.
PubMed 25935960Diamond MP, Daniell JF, Feste J, Surrey MW, McLaughlin DS, Friedman S, Vaughn WK, Martin DC. Adhesion reformation and de novo adhesion formation after reproductive pelvic surgery. Fertil Steril. 1987 May;47(5):864-6. doi: 10.1016/s0015-0282(16)59181-x.
PubMed 2952528DeCherney AH, Mezer HC. The nature of posttuboplasty pelvic adhesions as determined by early and late laparoscopy. Fertil Steril. 1984 Apr;41(4):643-6. doi: 10.1016/s0015-0282(16)47793-9.
PubMed 6231195Al-Jabri S, Tulandi T. Management and prevention of pelvic adhesions. Semin Reprod Med. 2011 Mar;29(2):130-7. doi: 10.1055/s-0031-1272475. Epub 2011 Mar 24.
PubMed 21437827Brochhausen C, Schmitt VH, Planck CN, Rajab TK, Hollemann D, Tapprich C, Kramer B, Wallwiener C, Hierlemann H, Zehbe R, Planck H, Kirkpatrick CJ. Current strategies and future perspectives for intraperitoneal adhesion prevention. J Gastrointest Surg. 2012 Jun;16(6):1256-74. doi: 10.1007/s11605-011-1819-9.
PubMed 22297658Coulthard LR, White DE, Jones DL, McDermott MF, Burchill SA. p38(MAPK): stress responses from molecular mechanisms to therapeutics. Trends Mol Med. 2009 Aug;15(8):369-79. doi: 10.1016/j.molmed.2009.06.005. Epub 2009 Aug 6.
PubMed 19665431
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Multi-center Randomized Double-blind Placebo-controlled Efficacy and Dose Ranging Trial of the Drug Product Seroguard, Solution (JSC Pharmasyntez, Russia) Used for the Prevention of Pelvic Adhesions
- ClinicalTrials.gov ID
- NCT03660787
- Acronym / sponsor ID
- SG-2/1215
- Conditions
- Adhesion
- Keywords
- Adhesion, Efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- PharmasyntezIndustry (pharma, biotech, devices)
- Collaborators
- Cromos Pharma LLC
- Study start
- 4 May 2017 (actual)
- Primary completion
- 23 Jan 2018 (actual)
- Study completion
- 23 Jan 2018 (actual)
- First posted
- 7 Sep 2018 (actual)
- Results
- Posted 19 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial was a multi-center, double-blind, randomized, parallel group, placebo-controlled, phase II study in adult hospitalized female patients with the confirmed diagnosis of pelvic adhesive disease in Study centres in Russia.
Detailed description
In order to evaluate efficacy and safety of Seroguard, solution for IP administration, a study design meeting the set objectives was selected: prospective, multi-center, double-blind, randomized, parallel group, placebo-controlled study.
Given the fact that comparison with placebo is considered the best way to prove efficacy and safety of a drug and that currently there are no drugs with a similar mechanism of action at the pharmaceutical product market, a placebo-controlled, parallel group study design was selected.
A randomized, parallel group study design was chosen in order to ensure minimization of a selection bias.
Subjects were randomized into four groups (two groups of the test drug and two placebo groups corresponding to the two doses) to enable a comparison of Seroguard administration at two doses.
A double-blind study design was selected in order to ensure minimization of an outcome evaluation bias.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo, 1.5 mL/kg | Placebo comparator | Drug: Placeboeach subject received the placebo at the dose of 1.5 mL/kg of body weight; |
| Placebo, 2.4 mL/kg | Placebo comparator | Drug: Placeboeach subject received the placebo at the dose of 2.4 mL/kg of body weight; |
| Seroguard, 1.5 mL/kg | Experimental | Drug: Seroguardeach subject received the test drug at the dose of 1.5 mL/kg of body weight; |
| Seroguard, 2.4 mL/kg | Experimental | Drug: Seroguardeach subject received the test drug at the dose of 2.4 mL/kg of body weight. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female patients aged from 18 to 45 years with the confirmed diagnosis of pelvic adhesions having indications for surgery (laparoscopic adhesiolysis).
- Voluntarily and personally signed and dated Form of Informed Consent.
- Female patients with pelvic adhesions confirmed by gynecological and ultrasound examination.
Key exclusion criteria (32 listed)
- Female patients having contraindications to surgical treatment (including acute or exacerbated chronical adnexal inflammation);
- Body mass index of 30.0 kg/m2 and more;
- Known hypersensitivity to the test drug components (Seroguard);
- Pregnancy, breastfeeding or planning a pregnancy during the clinical trial;
- Refusal to use effective contraception methods throughout the study;
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 |
|---|---|---|
| SeroguardSeroguard 0.41 g/L solution | Drug | Seroguard, 1.5 mL/kg, Seroguard, 2.4 mL/kg |
| PlaceboSaline | Drug | Placebo, 1.5 mL/kg, Placebo, 2.4 mL/kg |
Primary outcome
Number of Participants With Reduction of Adhesions Number by 3 or More
Time frame: 30±4 days after surgical intervention
The number of adhesions according to the first MRI data was compared to the number according to the data of second MRI
6 secondary outcomes
Change in Thickness of Pelvic Adhesions
Time frame: 30±4 days after surgery
Number of Participants With Detection of Pelvic Organs Limited Mobility
Time frame: 30±4 days after surgery
Number of Participants With Detection of Hyperechoic Linear Lesions Post Surgery
Time frame: 30±4 days after surgery
Change in Number of Participants in Detecting Pelvic Organs Limited Mobility
Time frame: 30±4 days after surgery
Change Number of Participants in Detecting Hyperechoic Linear Lesions
Time frame: 30±4 days after surgery
Number of Participants With Detection of no Ultrasound Signs of Pelvic Adhesive Disease Post Surgery
Time frame: 30±4 days after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10521760Miller JH, Weinberg RK, Canino NL, Klein NA, Soules MR. The pattern of infertility diagnoses in women of advanced reproductive age. Am J Obstet Gynecol. 1999 Oct;181(4):952-7. doi: 10.1016/s0002-9378(99)70331-5.
- Background: PubMed 23182560Dun EC, Nezhat CH. Tubal factor infertility: diagnosis and management in the era of assisted reproductive technology. Obstet Gynecol Clin North Am. 2012 Dec;39(4):551-66. doi: 10.1016/j.ogc.2012.09.006.
- Background: PubMed 123123Westrom L. Effect of acute pelvic inflammatory disease on fertility. Am J Obstet Gynecol. 1975 Mar 1;121(5):707-13. doi: 10.1016/0002-9378(75)90477-9.
- Background: PubMed 8042113Westrom LV. Sexually transmitted diseases and infertility. Sex Transm Dis. 1994 Mar-Apr;21(2 Suppl):S32-7.
- Background: PubMed 19562067Patil M. Assessing tubal damage. J Hum Reprod Sci. 2009 Jan;2(1):2-11. doi: 10.4103/0974-1208.51335.
- Background: PubMed 6667046Sutherland AM. The changing pattern of tuberculosis of the female genital tract. A thirty year survey. Arch Gynecol. 1983;234(2):95-101. doi: 10.1007/BF00207681.
- Background: PubMed 3785307Mueller BA, Daling JR, Moore DE, Weiss NS, Spadoni LR, Stadel BV, Soules MR. Appendectomy and the risk of tubal infertility. N Engl J Med. 1986 Dec 11;315(24):1506-8. doi: 10.1056/NEJM198612113152402.
- BackgroundSchwartz L, Diamond M. Formation, Reduction, and Treatment of Adhesive Disease. Seminars in Reproductive Medicine. 1991; 9(02): p. 89-99.
- Background: PubMed 24701493Vaid K, Mehra S, Verma M, Jain S, Sharma A, Bhaskaran S. Pan endoscopic approach "hysterolaparoscopy" as an initial procedure in selected infertile women. J Clin Diagn Res. 2014 Feb;8(2):95-8. doi: 10.7860/JCDR/2014/7271.4018. Epub 2014 Feb 3.
- Background: PubMed 25935960Neerja, Jain K. Role of laporoscopy-hysteroscopy in cases of infertility with pregnancy outcome. J Indian Med Assoc. 2014 Feb;112(2):85-6, 88.
- Background: PubMed 2952528Diamond MP, Daniell JF, Feste J, Surrey MW, McLaughlin DS, Friedman S, Vaughn WK, Martin DC. Adhesion reformation and de novo adhesion formation after reproductive pelvic surgery. Fertil Steril. 1987 May;47(5):864-6. doi: 10.1016/s0015-0282(16)59181-x.
- Background: PubMed 6231195DeCherney AH, Mezer HC. The nature of posttuboplasty pelvic adhesions as determined by early and late laparoscopy. Fertil Steril. 1984 Apr;41(4):643-6. doi: 10.1016/s0015-0282(16)47793-9.
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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.
Mikhail Shurygin, PhD,D.M.Sc. study chair
Pharmasyntez
14 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 Seroguard in people with Adhesion, run by Pharmasyntez at 14 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 3 inclusion and 32 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 19 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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. 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 19 Jun 2019). 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?
Number of Participants With Reduction of Adhesions Number by 3 or More (time frame: 30±4 days after surgical intervention). 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 NCT03660787, which also lists 35 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 19 Jun 2019.